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

Ovulation Inhibition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077555
• Other study ID #: Si804/2016
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2017
• Last updated: March 21, 2018
• Start date: January 21, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: March 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovulation Inhibition

Intervention

Drug:
• Zoely
quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate
• Meliane ED
quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation inhibition	comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting	1 month
Secondary	follicular development	pattern of ovarian follicular change after receive intervention	through study completion, an average of 1 month