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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3,173
- 主要终点
- Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: NOMAC-E2 (Drug)
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.
干预措施: Placebo (Other)
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.
干预措施: NETA-EE (Drug)
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.
干预措施: ethinylestradiol (EE) (Drug)
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.
干预措施: ferrous fumarate (Drug)
结局指标
主要结局
Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)
时间窗: Up to 1 year (13 cycles)
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.
次要结局
- Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting(Up to 1 year (13 cycles))
- Percentage of Participants With an Absence of Withdrawal Bleeding(Up to 1 year (13 cycles))
- Percentage of Participants Who Experienced At Least One Adverse Event(Up to 54 weeks)
- Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event(Up to 54 weeks)
- Change From Baseline in Body Weight(Baseline and Week 52)