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

Phase 4

Completed

• Conditions: Ovulation Inhibition
• Interventions: Drug: Zoely; Drug: Meliane ED

• Registration Number: NCT03077555
• Lead Sponsor: Mahidol University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-21
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• healthy women, age 18 - 40 years
• prior normal and regular interval of menstruation

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoely	Zoely	1.5 mg estradiol/2.5 mg nomegestrol acetate
Meliane ED	Meliane ED	20 mcg ethinyl estradiol/70 mcg gestodene

Primary Outcome Measures

Name	Time	Method
ovulation inhibition	1 month	comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting

Secondary Outcome Measures

Name	Time	Method
follicular development	through study completion, an average of 1 month	pattern of ovarian follicular change after receive intervention

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand