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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovulation Inhibition
• Intervention / Treatment: Drug: Meliane ED; Drug: Zoely

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meliane ED; 20 mcg ethinyl estradiol/70 mcg gestodene	Drug: Meliane ED; quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene; Other Names: ethinyl estradiol combined pills
Experimental: Zoely; 1.5 mg estradiol/2.5 mg nomegestrol acetate	Drug: Zoely; quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate; Other Names: estradiol hemihydrate combined pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovulation inhibition	comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
follicular development	pattern of ovarian follicular change after receive intervention	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: quick starting contraception
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Estradiol; Ethinyl Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: Si804/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No