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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Ovulation Inhibition

Treatments: Drug: Zoely; Drug: Meliane ED

Study type: Interventional

Funder types: Other

Identifiers

NCT03077555

Si804/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups

Meliane ED

Active Comparator group

Description:

20 mcg ethinyl estradiol/70 mcg gestodene

Treatment:

Drug: Meliane ED

Zoely

Experimental group

Description:

1.5 mg estradiol/2.5 mg nomegestrol acetate

Treatment:

Drug: Zoely