NCT03091595已完成2 期
A Single-center, Randomized, Open-label, Two-arm Study to Evaluate the Ovarian Function Inhibition of a Monophasic Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and a Monophasic COC Containing 20mcg Ethinylestradiol (EE)/3 mg DRSP (YAZ®), Administered Orally Once Daily in a 24/4 Day Regimen for Three Consecutive Cycles
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Estetra
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Proportion of subjects with ovarian inhibition at treatment Cycle 1
研究概览
简要总结
A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24 days followed by 4 placebo tablets, is being evaluated for further development. This study will investigate the effect of this COC on ovarian function inhibition, levels of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy female subjects, as determined by medical history, physical examination including breast examination, gynecological examination (including cervical smear [Pap smear]), vital signs, ECG, echocardiogram, and laboratory tests.
- •Negative pregnancy test at subject screening.
- •Women who ovulate in the Pre-Treatment Cycle.
- •Willing to use a non-hormonal method of contraception (e.g. condom) during the wash-out period, Pre-Treatment Cycle and Post-Treatment Cycle.
- •BMI between 18.0 and 35.0 kg/m², inclusive, at time of Screening.
- •Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent form (ICF).
排除标准
- •Irregular menstrual cycle.
- •Amenorrhea or abnormal uterine bleeding.
- •Clinically relevant abnormal laboratory result at Screening.
- •Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound.
- •Known hypersensitivity to any of the investigational or reference product ingredients.
- •Intention to become pregnant during the course of the study.
- •Pregnancy during accurate hormonal contraceptive use in the past.
- •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.
- •Any arterial hypertension.
- •Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
- •Complicated valvular heart disease.
- •History of pregnancy-related cardiomyopathy or moderately or severely impaired cardiac function.
- •Systemic lupus erythematosus.
- •Presence or history of migraine with aura.
- •Abnormal Papanicolaou (PAP) smear result.
- •Presence of an undiagnosed breast mass.
- •Current symptomatic gallbladder disease.
- •History of 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.
- •Use of drugs potentially triggering interactions with COCs.
- •History of alcohol or drug abuse.
- •Any prior procedure, disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.
- •Uncontrolled thyroid disorders.
- •Have received an investigational drug within the last 2 cycles prior to start of Pre-Treatment Cycle. Subjects who participated in an oral contraceptive clinical study, using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may start the Pre-Treatment Cycle one cycle after last medication intake of the preceding study.
- •Sponsor, contract research organization (CRO) or PI's site personnel directly affiliated with this study.
- •Is judged by the PI to be unsuitable for any reason.
研究组 & 干预措施
15 mg E4/3 mg DRSP
Experimental
15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen. One tablet per day orally for 3 treatment cycles.
干预措施: 15 mg E4/3 mg DRSP (Drug)
20 mcg EE/3 mg DRSP
Active Comparator
20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen. One tablet per day orally for 3 treatment cycles.
干预措施: 20 mcg EE/3 mg DRSP (Drug)
结局指标
主要结局
Proportion of subjects with ovarian inhibition at treatment Cycle 1
时间窗: All assessments will be performed once every 3 days starting treatment Cycle 1 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days).
Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on: * the follicular size assessed by transvaginal ultrasound (TVUS) * endogenous hormone levels: serum E2, and serum progesterone.
Proportion of subjects with ovarian inhibition at treatment Cycle 3
时间窗: All assessments will be performed once every 3 days starting treatment Cycle 3 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days).
Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on: * the follicular size assessed by TVUS * endogenous hormone levels: serum E2, and serum progesterone.
次要结局
- Serum level of luteinizing hormone (LH)(On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days))
- Number of participants who experience pregnancy during treatment(Cycle 1 Day 1 to Follow-Up Visit (+ 30 days) (each treatment cycle = 28 days))
- Serum level of estradiol (E2)(On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days))
- Serum level of progesterone (P)(On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days))
- Number of participants who experience a clinically significant change in electrocardiogram (ECG) results(Day 1 to End of Cycle 3 (Day 28) (each treatment cycle = 28 days))
- Number of participants who experience a clinically significant change in echocardiogram results(Day 1 to End of Cycle 3 (Day 28) (each treatment cycle = 28 days))
- Serum level of follicle stimulating hormone (FSH)(On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 (each treatment cycle = 28 days))
- Maximum endometrial thickness(From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days))
- Mean diameter of the largest follicle(Day 3 to Day 24 of Post-Treatment Cycle)
- Number of participants who experience at least one Treatment-Emergent Adverse Event (TEAE)(Day 1 to Follow-Up Visit (+ 30 days))
- Number of participants who experience a clinically significant change in physical examination results(Day 1 to End of Follow-Up Visit (+ 30 Days))
- Number of participants who experience a clinically significant change in gynecological examination results(Day 1 to End of Follow-Up Visit (+ 30 Days))
- Number of participants who experience a clinically significant change in clinical laboratory results(Day 1 to End of Follow-Up Visit (+ 30 Days))
- Change from Baseline in diastolic blood pressure(From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days))
- Change from Baseline in systolic blood pressure(From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days))
- Change from Baseline in pulse rate(From Baseline (study day 1), through 3 treatment cycles and up to Cycle Day 36 (±1) of the Post-Treatment Cycle (study day 120 (±1)) (each treatment cycle = 28 days))
研究者
研究点 (1)
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