NCT03077555

Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Ovulation Inhibition

Interventions

Type	Name	Description
DRUG	Zoely	quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate
DRUG	Meliane ED	quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene

Timeline

• Start date: 2017-01-21
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-03-13
• Last updated: 2018-03-23

Locations

1 site across 1 country: Thailand