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

P06448

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.

2012-11-02

2014-02-12

2014-02-12

Terminated

Early phase I

3173

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3173, 'type': 'ACTUAL'}}

2024-05-24