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ContraceptionPhase 3NCT01656434

Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)

A Phase 3 study testing NOMAC-E2, NETA-EE and ethinylestradiol (EE) in people with Contraception, run by Organon and Co.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. 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, NETA-EE and ethinylestradiol (EE)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,173 participants
Where
No sites listed yet
Study dates
2 Nov 2012to 12 Feb 2014
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 woman, at risk for pregnancy and in need of contraception
  • Not planning to use other contraceptive methods (including barrier methods [e.g., condoms]) than the study drug, during the study
  • Willing to use a COC for 12 months (13 cycles)
  • Body mass index (BMI) of ≥18 and <38 kg/m^2
  • Good physical and mental health
  • Willing to complete an electronic diary on a daily basis for the duration of the study

Who cannot join

  • Current smoker and age of >35 years
  • Presence or history of either venous thromboembolic diseases (deep vein thrombosis [DVT], pulmonary embolism) or arterial thromboembolic diseases (myocardial infarction, stroke)
  • History of migraine with focal neurological symptoms
  • Diabetes mellitus with vascular involvement
  • Less than two weeks of full remobilization from prolonged immobilization, major surgery, any surgery to the legs, or major trauma
  • Severe hypertension
Show all 18Show fewer
  • Severe abnormal lipoproteins in the blood
  • Pancreatic dysfunction
  • Presence of history of severe liver disease or liver tumors
  • Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts)
  • Undiagnosed vaginal bleeding
  • Known or suspected pregnancy
  • Current or history of abuse of alcohol or drugs (e.g., laxatives)
  • Abnormal cervical smear at screening
  • Prior to start of treatment, spontaneous menstruation has not occurred following a delivery or abortion
  • Breastfeeding or has been breastfeeding within 2 months prior to start of treatment
  • Use of any investigational drugs and/or participation in any other clinical trial within 2 months prior to start of treatment
  • Use of any of the following medications prior to or during the study may prohibit inclusion: sex hormones (other than pre- and post-treatment non-injectable contraceptives), injectable hormonal contraception, phenytoin, barbiturates, primidone, bosentan, carbamazepine, topiramate, felbamate, rifampicin, ritonavir, nevirapine, efavirenz, griseofulvin, herbal remedies containing Hypericum perforatum (e.g., St. John's wort)

About this study

Official title: A Phase III, Randomized, Open-label, Active-controlled, Multicenter Trial to Study the Contraceptive Efficacy and Safety of the Commercial Batch of Oral Tablets of MK-8175A (Nomegestrol Acetate - 17ß-estradiol) in Healthy, Sexually-active Women Aged 18-50 Years

The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.

Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio was adapted accordingly for participants randomized after the sample size increase.

Read the detailed description

This study was terminated early. The decision to terminate the study was based upon difficulties encountered with data collection (related to incomplete e-Diary entries) in concert with business considerations. The decision was not related to any new or unexpected safety or efficacy findings with NOMAC-E2. As a result of this early termination, none of the pre-specified efficacy endpoints were analyzed.

Conditions
Contraception
Being tested
NOMAC-E2, NETA-EE, Placebo, ethinylestradiol (EE), ferrous fumarate
Keywords
Combined Oral Contraceptives

What participants receive

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

  • NOMAC-E2Drug

    Also called MK-8175A, SCH 900121, Org 10486-0 (NOMAC), Org 2317 (E2)

    NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.

  • NETA-EEDrug

    Also called Lo Loestrin® Fe

    NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.

  • PlaceboOther

    tablet

  • ethinylestradiol (EE)Drug

    EE 10 μg tablet

  • ferrous fumarateDrug

    ferrous fumarate 75 mg tablet

Study groups in NCT01656434
Study groupRoleWhat they receive
NOMAC-E2ExperimentalParticipants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
Receives: Drug: NOMAC-E2; Other: Placebo
NETA-EEActive comparatorParticipants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Receives: Drug: NETA-EE; Drug: ethinylestradiol (EE); Drug: ferrous fumarate

What is being measured

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

  1. Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)

    Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.

    Measured: Up to 1 year (13 cycles)

Secondary outcomes (5)

  1. Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting

    Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING.

    Measured: Up to 1 year (13 cycles)

  2. Percentage of Participants With an Absence of Withdrawal Bleeding

    Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.

    Measured: Up to 1 year (13 cycles)

  3. Percentage of Participants Who Experienced At Least One Adverse Event

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

    Measured: Up to 54 weeks

  4. Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event

    Measured: Up to 54 weeks

  5. Change From Baseline in Body Weight

    Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.

    Measured: Baseline and Week 52

Timeline

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

  1. First posted3 Aug 2012 (estimated)
  2. Study start2 Nov 2012
  3. Primary completion12 Feb 2014
  4. Study completion12 Feb 2014

Why it stopped: Business reasons

Resources

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
3,173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01656434
Sponsor's protocol ID
P06448
Other IDs
MK-8175A-022, SCH 900121 P06448
Status last verified
Feb 2022
First submitted
31 Jul 2012
Last updated
20 Jun 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019.

    PubMed 31069056

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NOMAC-E2, NETA-EE and ethinylestradiol (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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 20 Jun 2024. 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 17 Mar 2015). 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?

Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index) (time frame: Up to 1 year (13 cycles)). 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 NCT01656434, 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 20 Jun 2024.

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