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临床试验/NCT03077555
NCT03077555已完成4 期

Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception Containing Estradiol Hemihydrate Compared to Ethinyl Estradiol

Mahidol University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年1月21日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

20 mcg ethinyl estradiol/70 mcg gestodene

干预措施: Meliane ED (Drug)

Zoely

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Preeyaporn Jirakittidul

Principle investigator

Mahidol University

研究点 (1)

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