NCT01221831已完成2 期
A Randomised Open-label Multi-centre Comparative Study to Evaluate Cycle Control of 2 Dosages of Estetrol Combined With Either P1 or P2, Compared to a Combined Oral Contraceptive Containing E2V and DNG
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
- 396
- 试验地点
- 10
- 主要终点
- Recording of vaginal bleeding events (diary) as a measure of Cycle control
研究概览
简要总结
This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age.
Primary objective:
- To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest
Secondary objectives:
- To investigate ovulation inhibition
- To investigate the effect on SHBG
- To assess pregnancy rate
- To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight
- To investigate return of menstruation after treatment
- To evaluate general safety and acceptability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Women willing to use a Combined Oral Contraceptive for 6 subsequent cycles
- •Good physical and mental health
- •Regular menstrual cycle (24-35 days) prior to screening
- •Body mass index between (≥) 18 and (≤) 30 kg/m2
排除标准
- •Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (only applicable for women who are not using a hormonal contraceptive method at the time of screening)
- •Previous use of progestogen-only contraceptive methods during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception
- •Use of phytoestrogens
- •No spontaneous menstruation has occurred following a delivery or abortion
- •Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
- •Status post-partum or post-abortion within a period of 2 months before screening
- •Pregnancy during accurate hormonal contraceptive use in the past
- •Intention to become pregnant during the study
- •An abnormal cervical smear within one year before study start
- •Untreated Chlamydia infection
- •Known or suspected breast cancer or a history of breast cancer
- •A history of (within 12 months) alcohol or drug abuse
- •Any clinically relevant abnormality
- •Contraindications for the contraceptive steroids used in the clinical trial
- •Use of antihypertensive drugs or use of medications interacting with the contraceptive steroids used in the clinical trial
- •Administration of any other investigational drug within 2 months prior to screening
研究组 & 干预措施
estetrol dose 1 / P1
Experimental
干预措施: estetrol, P 1 and placebo tablets (Drug)
estetrol dose 1 / P2
Experimental
干预措施: estetrol, P2 and placebo tablets (Drug)
estradiol valerate/dienogest pill
Active Comparator
干预措施: Estradiol valerate, dienogest and placebo tablets (Drug)
estetrol dose 2 / P1
Experimental
干预措施: estetrol, P 1 and placebo tablets (Drug)
estetrol dose 2 / P2
Experimental
干预措施: estetrol, P2 and placebo tablets (Drug)
结局指标
主要结局
Recording of vaginal bleeding events (diary) as a measure of Cycle control
时间窗: 6 cycles of 28 days
次要结局
- Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition(6 cycles of 28 days)
- Patient Reported Outcome questionnaire as a measure of Subject satisfaction(6 cycles of 28 days)
- Contacts patient-investigator to document Return of menstruation(for up to 1 year follow-up)
- Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability(up to 8 months)
- Measurement of SHBG in blood samples to assess the effect of treatment on SHBG(6 cycles of 28 days)
- Reporting of in-treatment pregnancies as a measure of pregnancy rate(6 cycles of 28 days)
研究者
研究点 (10)
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