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

NCT ID: NCT01656434

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-02
• Study Completion Date: 2014-02-12

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NOMAC-E2

Participants 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.

Group Type: EXPERIMENTAL

NOMAC-E2

Intervention Type: DRUG

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

Placebo

Intervention Type: OTHER

tablet

NETA-EE

Participants 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.

Group Type: ACTIVE_COMPARATOR

NETA-EE

Intervention Type: DRUG

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

ethinylestradiol (EE)

Intervention Type: DRUG

EE 10 μg tablet

ferrous fumarate

Intervention Type: DRUG

ferrous fumarate 75 mg tablet

Interventions

NOMAC-E2

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

Intervention Type: DRUG

NETA-EE

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

Intervention Type: DRUG

Placebo

tablet

Intervention Type: OTHER

ethinylestradiol (EE)

EE 10 μg tablet

Intervention Type: DRUG

ferrous fumarate

ferrous fumarate 75 mg tablet

Intervention Type: DRUG

Other Intervention Names

MK-8175A; SCH 900121; Org 10486-0 (NOMAC); Org 2317 (E2); Lo Loestrin® Fe

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 31069056 (View on PubMed)

Other Identifiers

MK-8175A-022

Identifier Type: OTHER

Identifier Source: secondary_id

SCH 900121 P06448

Identifier Type: OTHER

Identifier Source: secondary_id

P06448

Identifier Type: -

Identifier Source: org_study_id