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

• Status: Terminated
• Trial end date: 2014-02-12
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Ethinyl Estradiol; Ferrous fumarate; Megestrol; Norethindrone acetate

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)