Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception Containing Estradiol Hemihydrate Compared to Ethinyl Estradiol
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- ovulation inhibition
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Meliane ED
20 mcg ethinyl estradiol/70 mcg gestodene
Intervention: Meliane ED (Drug)
Zoely
1.5 mg estradiol/2.5 mg nomegestrol acetate
Intervention: Zoely (Drug)
Outcomes
Primary Outcomes
ovulation inhibition
Time Frame: 1 month
comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting
Secondary Outcomes
- follicular development(through study completion, an average of 1 month)
Investigators
Preeyaporn Jirakittidul
Principle investigator
Mahidol University
