ContraceptionPhase 3NCT00511342
Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)
A Phase 3 study testing NOMAC-E2 and LNG-EE in people with Contraception, run by Organon and Co.
Trial summary
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- NOMAC-E2 and LNG-EE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Jun 2009
- 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 20 to 35 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 condoms
- during treatment;
- At least 20 but not older than 35 years of age at the time of screening;
- BMI = 17 and = 35;
- Good physical and mental health;
- Willing to give informed consent in writing;
- Willing to take part in the trial for two years.
Who cannot join
- Family history of osteoporotic fracture below the age of 70;
- Postgastrectomy;
- History of eating disorder, viz. anorexia nervosa, bulimia;
- Endocrine disorder (including controlled diabetes, [para]thyroid disease, Cushing's disease);
- Rheumatoid arthritis;
- Significant scoliosis;
Show all 30Show fewer
- Fasting parathyroid hormone (PTH) outside the reference range at screening;
- Fasting calcitonin outside the reference range at screening;
- Prolactin above the reference range (hyperprolactinemia) at screening;
- Fasting cholesterol and/or triglycerides above the reference range for age at screening (treatment with lipid lowering drugs not allowed);
- Engaging in vigorous exercise such as marathon, competitive swimming, triathlon;
- Smoking more than ten cigarettes/day;
- Use of more than two units of alcohol a day;
- Use of one or more of the following drugs:
- gonadotropin releasing hormone (GnRH) analogues (also past use for more than six months at any time, or for any period of time less than six months ago is a contraindication);
- systemic or inhaled administration of corticosteroids (also past use for more than one year, less than five years ago or any period of time in the past year is a contraindication);
- thiazide diuretics;
- thyroid hormone;
- bisphosphonates;
- calcium supplementation in combination with vitamin D supplementation/
- calcitonin;
- ever treatment after childhood with fluorides;
- Contraindications for contraceptive steroids
- An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia[CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;
- Clinically relevant abnormal laboratory result at screening as judged by the investigator;
- Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
- Within 12 months after a pregnancy prior to the start of trial medication;
- Breastfeeding or within 12 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, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
- 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: An Open-Label, Randomized, Single Center Trial in Healthy Young Women, to Evaluate the Effects of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg NOMAC and 1.5 mg E2 on Bone Mineral Density (BMD) Compared to a Monophasic COC Containing 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol
The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).
- Conditions
- Contraception
- Being tested
- NOMAC-E2, LNG-EE
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
Nomegestrol Acetate and Estradiol 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 26 consecutive 28-day menstrual cycles (2 years).
LNG-EEDrug
Also called SCH 900121
Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
| 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 COC Receives: Drug: NOMAC-E2 |
| LNG-EE | Active comparator | Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC Receives: Drug: LNG-EE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck
BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, \& more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).
Measured: Baseline and after cycle 26 (2 years)
Secondary outcomes (9)
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Contraceptive efficacy parameter of this trial was the 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 two days. Each 13 cycles (28 days per cycle) of exposure 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: 2 years (26 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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
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 cards. 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: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
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 cards. 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: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
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 cards. 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: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment
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 cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
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 cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Measured: Every 28-day cycle for 26 cycles (2 years total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionJun 2009
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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511342
- Sponsor's protocol ID
- P05765
- Other IDs
- Organon Protocol No. 292005
- 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
Sordal T, Grob P, Verhoeven C. Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17beta-estradiol in comparison to levonorgestrel/ethinylestradiol. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1279-85. doi: 10.1111/j.1600-0412.2012.01498.x. Epub 2012 Aug 21.
PubMed 22762147
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
- An Open-Label, Randomized, Single Center Trial in Healthy Young Women, to Evaluate the Effects of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg NOMAC and 1.5 mg E2 on Bone Mineral Density (BMD) Compared to a Monophasic COC Containing 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol
- ClinicalTrials.gov ID
- NCT00511342
- Acronym / sponsor ID
- P05765
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Posted 29 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 NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).
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 COC |
| LNG-EE | Active comparator | Drug: LNG-EELevonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sexually active women, at risk for pregnancy and not planning to use condoms
- during treatment;
- At least 20 but not older than 35 years of age at the time of screening;
- BMI = 17 and = 35;
- Good physical and mental health;
Key exclusion criteria (30 listed)
- Family history of osteoporotic fracture below the age of 70;
- Postgastrectomy;
- History of eating disorder, viz. anorexia nervosa, bulimia;
- Endocrine disorder (including controlled diabetes, [para]thyroid disease, Cushing's disease);
- Rheumatoid arthritis;
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 900121Nomegestrol Acetate and Estradiol 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 26 consecutive 28-day menstrual cycles (2 years). | Drug | NOMAC-E2 |
| LNG-EEAlso: SCH 900121Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). | Drug | LNG-EE |
Primary outcome
Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck
Time frame: Baseline and after cycle 26 (2 years)
BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, \& more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).
9 secondary outcomes
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Time frame: 2 years (26 cycles)
Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Number of Participants With an Occurrence of Breakthrough Bleeding
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Time frame: Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment
Average Number of Breakthrough Bleeding-Spotting Days
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Average Number of Withdrawal Bleeding-spotting Days
Time frame: Every 28-day cycle for 26 cycles (2 years total)
Results and safety
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 22762147Sordal T, Grob P, Verhoeven C. Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17beta-estradiol in comparison to levonorgestrel/ethinylestradiol. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1279-85. doi: 10.1111/j.1600-0412.2012.01498.x. Epub 2012 Aug 21.
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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 LNG-EE 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 7 inclusion and 30 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 29 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?
Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck (time frame: Baseline and after cycle 26 (2 years)). 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 NCT00511342, 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.