ContraceptionPhase 3NCT00511355

Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)

A Phase 3 study testing NOMAC-E2 and Levonorgestrel and Ethinyl Estradiol in people with Contraception, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: NOMAC-E2 and Levonorgestrel and Ethinyl Estradiol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: No sites listed yet
Study dates: Oct 2006to Jan 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index = 17 and = 29 kg/m^2;
Good physical and mental health;
Willing to give informed consent in writing

Who cannot join

Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
Contraindications for contraceptive steroids
Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;
Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;

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Before spontaneous menstruation has occurred following a delivery or abortion;
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort);
Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.

About this study

Official title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids and Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.

Conditions: Contraception
Being tested: NOMAC-E2, Levonorgestrel and Ethinyl Estradiol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NOMAC-E2Drug
Also called SCH 900121, Org 10486-0 (NOMAC), Org 2317 (E2)
Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Levonorgestrel and Ethinyl EstradiolDrug
Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.

Study groups in NCT00511355
Study group	Role	What they receive
NOMAC-E2	Experimental	Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive Receives: Drug: NOMAC-E2
LNG-EE	Active comparator	Levonorgestrel and Ethinyl Estradiol Tablets (LNG-EE), 150 mcg LNG and 30 mcg EE Receives: Drug: Levonorgestrel and Ethinyl Estradiol

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Concentration of Prothrombin Fragments 1 + 2
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of D-Dimer
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor VIIa
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor VIIc
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor VIII
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor II
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Antithrombin III
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Protein S (Free)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Protein S (Total)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Protein C
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Sex Hormone Binding Globulin (SHBG)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of C-Reactive Protein (CRP)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of HDL2-cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of HDL3-cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Apolipoprotein A-1
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Apolipoprotein B
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Lipoprotein(a)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Triglycerides
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])
Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Incremental AUC3 for Glucose (OGTT)
Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
AUC3 for Insulin (OGTT)
Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Incremental AUC3 for Insulin (OGTT)
Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Hemoglobin Type A1c (HbA1c)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Cortisol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Corticosteroid Binding Globulin (CBG)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline to Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Thyroid Stimulating Hormone (TSH)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Free Thyroxine (T4)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Thyroxin Binding Globulin (TBG)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)

Secondary outcomes (14)

Serum Concentration of Total Testosterone
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Free Testosterone
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Androstenedione
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Dihydrotestosterone (DHT)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Measured: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Measured: 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Measured: Every 28-day cycle for 5 cycles
Average Number of Breakthrough Bleeding/Spotting Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Average Number of Withdrawal Bleeding/Spotting Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.
Measured: Every 28-day cycle for 6 cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Jan 2008

First posted3 Aug 2007 (estimated)
Study startOct 2006
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00511355
Sponsor's protocol ID: P05764
Other IDs: Organon Protocol No. 292004
Status last verified: Feb 2022
First submitted: 2 Aug 2007
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Agren UM, Anttila M, Maenpaa-Liukko K, Rantala ML, Rautiainen H, Sommer WF, Mommers E. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism. Eur J Contracept Reprod Health Care. 2011 Dec;16(6):444-57. doi: 10.3109/13625187.2011.604450.
PubMed 22066891

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids and Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE
ClinicalTrials.gov ID: NCT00511355
Acronym / sponsor ID: P05764
Conditions: Contraception
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 3 Aug 2007 (estimated)
Results: Posted 30 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NOMAC-E2	Experimental	Drug: NOMAC-E2Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive
LNG-EE	Active comparator	Drug: Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl Estradiol Tablets (LNG-EE), 150 mcg LNG and 30 mcg EE

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
At least 18 but not older than 50 years of age at the time of screening;
Body mass index = 17 and = 29 kg/m^2;
Good physical and mental health;

Key exclusion criteria (11 listed)

Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
Contraindications for contraceptive steroids
Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NOMAC-E2Also: SCH 900121, Org 10486-0 (NOMAC), Org 2317 (E2)Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.	Drug	NOMAC-E2
Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.	Drug	LNG-EE

Primary outcome

Serum Concentration of Prothrombin Fragments 1 + 2
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of D-Dimer
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.
Serum Concentration of Clotting Factor VIIa
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Clotting Factor VIIc
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Clotting Factor VIII
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Clotting Factor II
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Antithrombin III
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Protein S (Free)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Protein S (Total)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Protein C
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.
Serum Concentration of Sex Hormone Binding Globulin (SHBG)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of C-Reactive Protein (CRP)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Total Cholesterol
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of HDL2-cholesterol
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of HDL3-cholesterol
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Apolipoprotein A-1
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Apolipoprotein B
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Lipoprotein(a)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Total Triglycerides
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.
Incremental AUC3 for Glucose (OGTT)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.
AUC3 for Insulin (OGTT)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.
Incremental AUC3 for Insulin (OGTT)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.
Serum Concentration of Hemoglobin Type A1c (HbA1c)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.
Serum Concentration of Total Cortisol
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Corticosteroid Binding Globulin (CBG)
Time frame: Baseline to Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Thyroid Stimulating Hormone (TSH)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Free Thyroxine (T4)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Serum Concentration of Thyroxin Binding Globulin (TBG)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.

14 secondary outcomes

Serum Concentration of Total Testosterone
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Free Testosterone
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Androstenedione
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Dihydrotestosterone (DHT)
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Time frame: 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Time frame: Every 28-day cycle for 5 cycles
Average Number of Breakthrough Bleeding/Spotting Days
Time frame: Every 28-day cycle for 6 cycles
Average Number of Withdrawal Bleeding/Spotting Days
Time frame: Every 28-day cycle for 6 cycles

Results and safety

Results posted to the registry on 30 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NOMAC-E2	60	53
LNG-EE	61	52

Primary outcome: Serum Concentration of Prothrombin Fragments 1 + 2

Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle). Mean (Standard Deviation). Unit: nmol/L

Measure	NOMAC-E2 n = 60	LNG-EE n = 58
Baseline (n=60 NOMAC-E2; n=58 LNG-EE)	0.18 (0.20)	0.19 (0.08)
Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	0.31 (1.06)	0.42 (1.17)

NOMAC-E2 vs LNG-EE: p = 0.0849, Cochran-Mantel-Haenszel

Population analysed: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6

Primary outcome: Serum Concentration of D-Dimer

Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle). Mean (Standard Deviation). Unit: mg/L Fibrinogen Equivalent Units (FEU)

Measure	NOMAC-E2 n = 60	LNG-EE n = 58
Baseline (n=60; NOMAC-E2; n=58)	0.21 (0.16)	0.19 (0.14)
Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	0.18 (0.14)	0.26 (0.21)

Population analysed: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6

Primary outcome: Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)

Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle). Mean (Standard Deviation). Unit: Ratio

Measure	NOMAC-E2 n = 60	LNG-EE n = 58
Baseline (n=59 NOMAC-E2; n=58 LNG-EE)	0.80 (0.33)	0.83 (0.40)
Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	1.14 (0.45)	1.99 (0.76)

NOMAC-E2 vs LNG-EE: p <.0001, Cochran-Mantel-Haenszel

Population analysed: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6

Primary outcome: Serum Concentration of Clotting Factor VIIa

Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle). Mean (Standard Deviation). Unit: U/L

Measure	NOMAC-E2 n = 60	LNG-EE n = 58
Baseline (n=60 NOMAC-E2; n=58 LNG-EE)	84 (32)	85 (37)
Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE)	118 (180)	98 (66)

NOMAC-E2 vs LNG-EE: p = 0.4191, Cochran-Mantel-Haenszel

Population analysed: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NOMAC-E2	1 of 60 (1.7%)	9 of 60 (15%)	Not reported
LNG-EE	0 of 58 (0%)	18 of 58 (31%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22066891Agren UM, Anttila M, Maenpaa-Liukko K, Rantala ML, Rautiainen H, Sommer WF, Mommers E. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17beta-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism. Eur J Contracept Reprod Health Care. 2011 Dec;16(6):444-57. doi: 10.3109/13625187.2011.604450.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NOMAC-E2 and Levonorgestrel and Ethinyl Estradiol in people with Contraception, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Concentration of Prothrombin Fragments 1 + 2 (time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00511355, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.