NCT02817841已完成3 期
A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Estetra
- 入组人数
- 2,148
- 试验地点
- 2
- 主要终点
- The Number of On-treatment Pregnancies (With + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 16 to 35 Years, Inclusive, at the Time of Screening
研究概览
简要总结
The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Heterosexually active female at risk for pregnancy and requesting contraception.
- •Negative serum pregnancy test at subject screening.
- •Willing to use the investigational product as the primary method of contraception for 13 consecutive cycles.
- •Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, and vital signs.
- •Body mass index (BMI) below or equal to (≤) 35.0 kg/m
- •Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent.
- •Willing and able to complete the diaries and questionnaires.
排除标准
- •Known hypersensitivity to any of the investigational product ingredients.
- •Smoking if ≥ 35 years old, at screening.
- •Any condition associated with decrease fertility.
- •Dyslipoproteinemia requiring active treatment with antilipidemic agent.
- •Diabetes mellitus with vascular involvement (nephropathy, retinopathy, neuropathy, other) or diabetes mellitus of more than 20-year duration.
- •Arterial hypertension.
- •Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
- •Any condition associated with abnormal uterine/vaginal bleeding.
- •Abnormal Pap test based on current international recommendations.
- •Presence of an undiagnosed breast mass.
- •Current symptomatic gallbladder disease.
- •History of combined oral contraceptive (COC) related cholestasis.
- •Presence or history of severe hepatic disease.
- •Presence or history of pancreatitis if associated with hypertriglyceridemia.
- •Porphyria.
- •Presence or history of hepatocellular adenoma or malignant liver tumors.
- •Renal impairment.
- •Hyperkaliemia or presence of conditions that predispose to hyperkaliemia.
- •Presence or history of hormone-related malignancy.
- •History of non-hormone-related malignancy within 5 years before screening. Subjects with a non-melanoma skin cancer are allowed in the study.
- •History of alcohol or drug abuse (including laxatives) within 12 months prior to screening.
- •Use of drugs potentially triggering interactions with COCs.
- •Any condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.
- •Uncontrolled thyroid disorders.
- •Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to study entry. Subjects who participated in an oral contraceptive clinical study, using FDA/European (EU) approved active ingredients, may be enrolled 2 months (60 days) after completing the preceding study.
- •Sponsor, Contract Research Organization (CRO) or Investigator's site personnel directly affiliated with this study.
- •Is judged by the Investigator to be unsuitable for any reason.
研究组 & 干预措施
15 mg E4/3 mg DRSP
Experimental
15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive
干预措施: 15 mg E4/3 mg DRSP (Drug)
结局指标
主要结局
The Number of On-treatment Pregnancies (With + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 16 to 35 Years, Inclusive, at the Time of Screening
时间窗: Up to 12 months (13 cycles with 1 cycle = 28 days)
On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. Only at-risk cycles were included in the denominator of the Pearl Index calculation, unless a conception occurred during a cycle. At-risk-cycle was defined as cycle in which no other methods of birth control (including condoms and emergency contraception) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.
次要结局
- Rate of Pregnancy (Life-table Analysis) in Participants Aged 16 to 35 Years(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Unscheduled Spotting Days Per Cycle(Up to 11 months (12 cycles with 1 cycle = 28 days))
- The Number of On-treatment Pregnancies (With +7-day Window) as Assessed by the Method Failure Pearl Index in Subjects Aged 16 to 35 Years, Inclusive, at the Time of Screening(Up to 12 months (13 cycles with 1 cycle = 28 days))
- The Number of On-treatment Pregnancies as Assessed by the Method Failure Pearl Index in the Overall Study Population (16-50 Years)(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Subjects With Unscheduled Bleeding/Spotting Episodes(Up to 11 months (12 cycles with 1 cycle = 28 days))
- Number of Unscheduled Bleeding Days Per Cycle(Up to 11 months (12 cycles with 1 cycle = 28 days))
- Mean Number of Bleeding and Spotting Days by Reference Period(up to 12 months (13 cycles))
- Number of Subjects With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability.(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Participants With Clinically Significant out-of Range Hematology Results(Up to 12 months (13 cycles with 1 cycle = 28 days))
- The Number of On-treatment Pregnancies (With + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in the Overall Study Population (16-50 Years)(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Rate of Pregnancy (Life-table Analysis) in Participants Aged 16 to 50 Years(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Participants With Clinically Significant out-of Range Serum Chemistry and Lipid Profile Results(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Participants With Clinically Abnormal Gynecological Examination Results(Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days))
- Number of Subjects With Absence of Scheduled Bleeding and/or Spotting(Up to 11 months (12 cycles with 1 cycle = 28 days))
- Number of Scheduled Bleeding and/or Spotting Days Per Cycle(Up to 11 months (12 cycles with 1 cycle = 28 days))
- Number of Subjects With Bleeding and/or Spotting Episodes by Reference Period(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Subjects With Clinically Abnormal Vital Signs(Up to 12 months (13 cycles with 1 cycle = 28 days))
- Number of Participants With Clinically Abnormal Physical Examination Results(Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days))
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Percentage Maximum (Sum of First 14 Items)(Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days))
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Satisfaction With Medicine and Overall Life Satisfaction and Contentment Over the Past Week(Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days))
- Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)(Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days))
研究者
研究点 (2)
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