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

Organon

Status and phase: Terminated; Phase 3

Conditions: Contraception

Treatments: Drug: ethinylestradiol (EE); Drug: ferrous fumarate; Other: Placebo; Drug: NETA-EE; Drug: NOMAC-E2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656434

SCH 900121 P06448 (Other Identifier)

MK-8175A-022 (Other Identifier)

P06448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,173 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,173 participants in 2 patient groups

NOMAC-E2

Experimental group

Description:

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.

Treatment:

Drug: NOMAC-E2

Other: Placebo

NETA-EE

Active Comparator group

Description:

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.

Treatment:

Drug: NETA-EE

Drug: ferrous fumarate

Drug: ethinylestradiol (EE)