A Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3,055
- 试验地点
- 80
- 主要终点
- Number of Participants With On-treatment Pregnancies
研究概览
简要总结
The purpose of this study is evaluating Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive in Premenopausal Females Aged 14 to 35 Years (Inclusive).
详细描述
This is a Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive). Potential participants must be sexually active and engage in heterosexual vaginal intercourse at least once per month with a partner who is not known to be subfertile, sterilized, or infertile, and should not routinely use any other form of contraception.
A total of 2,680 fertile premenopausal women aged 14 to 35 years (inclusive) will be screened to achieve about 1,878 (with at least 657 participants with BMI ≥30 kg/m2) being allocated to study treatment. Over 1,000 total participants are expected to complete 1 year of treatment (13 cycles).
The total duration of study participation will be up to 60 weeks, which includes a Pre-treatment Period of approximately 6 weeks, a Treatment Period of 52 weeks, and a Follow-up Period of 2 weeks after the last intake of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenarcheal, premenopausal female aged 14 to 35 years (inclusive)
- •At risk for pregnancy (including heterosexual vaginal intercourse at least once a month and not sterilized).
- •No desire for pregnancy within 1 year following screening and is not intending to use any other form of contraception
- •Good physical and mental health
- •History of regular menstrual cycles prior to the use of any hormonal contraceptive.
- •Able and willing to adhere study procedures
排除标准
- •Current known or expected pregnancy
- •History of subfertility or infertility
- •Less than 2 normal menstrual cycles following recent pregnancy of gestational age
- •Breastfeeding within 2 months of study drug start
- •Known HIV infection
- •Untreated gonorrhea, chlamydia, or trichomonas
- •abnormal PAP within timeline of standard of care guidelines
- •Unexplained/unresolved abnormal vaginal bleeding
- •Presence/history of VTE, ATE, transient ischemic attack, angina pectoris, or claudication
- •Higher risk for VTE
- •Uncontrolled or severe hypertension
- •Severe dyslipoproteinemia
- •History of migraine with aura or focal neurological symptoms
- •Diabetes mellitus (with either end-organ involvement or >20 years duration)
- •Multiple cardiovascular risk factors
- •History of pancreatitis associated with severe hypertriglyceridemia
- •Presence/history of clinically significant liver disease
- •History of malabsorptive surgical procedures
- •History of malignancy in last 5 years
- •Presence/history of meningioma
- •Disease that may worsen under hormonal treatment
- •Presence/history of severe depression (unless currently stable and asymptomatic)
- •Known allergy/sensitivity to NOMAC-E2
- •Drug or alcohol abuse/dependence in last 2 years
- •Clinically relevant abnormal lab result at screening
- •Expected use of other contraceptive medications or medications that induce liver enzymes during study
- •Used another investigational drug within 2 months of study drug start
研究组 & 干预措施
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
干预措施: NOMAC-E2 COC (Drug)
结局指标
主要结局
Number of Participants With On-treatment Pregnancies
时间窗: 1 year
Raw count of the number of pregnancies that occurred while participants were taking study drug
次要结局
- Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)(1 year)
- Proportion of Participants Who Prematurely Discontinue Study Drug Treatment(1 year)
- Number of Cycles of Exposure Prior to Pregnancy(1 year)
- Mean Number of Bleeding and/or Spotting Days Per Cycle(28-day cycles across one year)
- Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle(1 year)
- Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)(1 year)
- Proportion of Participants With Bleeding-spotting Days(28-day cycles across one year)
- Average Number of Bleeding-spotting Days Per Reference Period(91-day reference periods across one year)
- Proportion of Participants With 8 or More Bleeding-spotting Days(28-day cycles across one year)
- Mean NOMAC Concentration, Visit 3 Pre-Dose(Treatment Week 5)
- Mean NOMAC Concentration, Visit 3 Post-Dose(Treatment Week 5)
- Mean NOMAC Concentration, Visit 4 Pre-Dose(Treatment Week 17)
- Mean NOMAC Concentration, Visit 4 Post-Dose(Treatment Week 17)