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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovulation Inhibition

Intervention / Treatment
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* Drug: Zoely
* Drug: Meliane ED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy women, age 18 - 40 years prior normal and regular interval of menstruation 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two intervention groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meliane ED<br>20 mcg ethinyl estradiol/70 mcg gestodene | Drug: Meliane ED<br>* quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene<br>* Other names: ethinyl estradiol combined pills;|
| Experimental: Zoely<br>1.5 mg estradiol/2.5 mg nomegestrol acetate | Drug: Zoely<br>* quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate<br>* Other names: estradiol hemihydrate combined pills;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation inhibition | comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follicular development | pattern of ovarian follicular change after receive intervention | through study completion, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quick starting contraception