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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-21

Study Completion Date

2018-02-28

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.

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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.

Conditions

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Ovulation Inhibition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two intervention groups

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Meliane ED

20 mcg ethinyl estradiol/70 mcg gestodene

Group Type ACTIVE_COMPARATOR

Meliane ED

Intervention Type DRUG

quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene

Zoely

1.5 mg estradiol/2.5 mg nomegestrol acetate

Group Type EXPERIMENTAL

Zoely

Intervention Type DRUG

quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate

Interventions

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Zoely

quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate

Intervention Type DRUG

Meliane ED

quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene

Intervention Type DRUG

Other Intervention Names

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estradiol hemihydrate combined pills ethinyl estradiol combined pills

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes