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Clinical Trials/NCT03077555
NCT03077555CompletedPhase 4

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

Mahidol University1 site in 1 country69 target enrollmentStarted: January 21, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
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

Active Comparator

20 mcg ethinyl estradiol/70 mcg gestodene

Intervention: Meliane ED (Drug)

Zoely

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Preeyaporn Jirakittidul

Principle investigator

Mahidol University

Study Sites (1)

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