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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

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

Phase: Phase 3

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17-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.

Clinical Details

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 - 17-estradiol) in Healthy, Sexually-active Women Aged 18-50 Years

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)

Secondary outcome:

Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting

Percentage of Participants With an Absence of Withdrawal Bleeding

Percentage of Participants Who Experienced At Least One Adverse Event

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

Change From Baseline in Body Weight

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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)

Locations and Contacts

Additional Information

Starting date: November 2012
Last updated: March 12, 2015

Page last updated: August 23, 2015

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