An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Number of In-treatment Pregnancies
研究概览
简要总结
This study will investigate the efficacy and safety of the monophasic
combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in
healthy fertile Indian women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active and at risk for pregnancy
- •Of Indian descent, born in India, never emigrated out of India, with Indian
- •home address
- •Body mass index (BMI) ≥17 and ≤35 kg/m^2
排除标准
- •Presence or history of venous or arterial thrombotic/thromboembolic events
- •or cerebrovascular accident
- •Presence or history of prodromi of a thrombosis
- •History of migraine with focal neurological symptoms
- •Diabetes mellitus with vascular involvement
- •Presence of a severe or multiple risk factor(s) for venous or arterial
- •Severe hypertension
- •Severe dyslipoproteinemia
- •Presence or history of pancreatitis associated with severe
- •hypertriglyceridemia
- •Presence or history of severe hepatic disease
- •Undiagnosed vaginal bleeding
- •Known or suspected pregnancy
- •Currently breastfeeding or breastfeeding within 2 months of starting
- •trial medication
- •Investigational drug use or participation in another clinical trial within
- •2 months of signing Informed Consent Form for current trial
研究组 & 干预措施
NOMAC-E2 2.5 mg/1.5 mg
Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day.
干预措施: Nomegestrol acetate (NOMAC) (Drug)
NOMAC-E2 2.5 mg/1.5 mg
Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day.
干预措施: Estradiol (E2) (Drug)
结局指标
主要结局
Number of In-treatment Pregnancies
时间窗: Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)
次要结局
- Number of Participants Experiencing an Adverse Event (AE) or Serious AE("From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).)