Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception Containing Estradiol Hemihydrate Compared to Ethinyl Estradiol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- ovulation inhibition
研究概览
简要总结
Quick starting combined oral contraception containing estradiol hemihydrate/nomegestrol acetate is effective to inhibit ovulation in healthy reproductive age women and non-inferiority to combined oral contraception containing ethinyl estradiol/gestodene.
详细描述
This study is a randomized control, non-inferiority trial which compare the proportion of ovulation between two oral combined pills when delay starting the first tablet at mid-follicular phase of menstrual cycle in 18 - 40 year old, healthy women with prior normal and regular periods. Participations will be undergone trans-vaginal or trans-rectal ultrasonography between day 1 - 3 of menstrual period for evaluation of ovarian follicle/cyst (if present). Only women who have normal looking of ovaries without dominant ovarian follicle will be included in study-protocol. Immediately after trans-vaginal/trans-rectal ultrasound between day 7 - 9 of menstrual period, all participants will be randomly assigned to receive one pack of investigated pills (1.5 mg estradiol hemihydrate/2.5 mg nomegestrol acetate or 20 mcg ethinyl estradiol/75 mcg gestodene) and to take the first tablet under direct observation by research-nurse. Participants will take one consecutive tablet at about the same time each day until complete pack. The next appointments will be every 2 - 3 days to monitor ovarian function by using Hoogland score until ovulation or follicular quiescence will be presented. The last visit will be about 1 week after complete pack to monitor adverse effect and safety through out the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women, age 18 - 40 years
- •prior normal and regular interval of menstruation
排除标准
- •current breast feeding women
- •within 1 month period of child-delivery or miscarriage
- •body mass index 30 kg/m2 or more
- •contraindicated to use combined hormonal contraception
- •current using other hormonal drugs that affect ovulation function
研究组 & 干预措施
Meliane ED
20 mcg ethinyl estradiol/70 mcg gestodene
干预措施: Meliane ED (Drug)
Zoely
1.5 mg estradiol/2.5 mg nomegestrol acetate
干预措施: Zoely (Drug)
结局指标
主要结局
ovulation inhibition
时间窗: 1 month
comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting
次要结局
- follicular development(through study completion, an average of 1 month)
研究者
Preeyaporn Jirakittidul
Principle investigator
Mahidol University
