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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03077555
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
Preeyaporn Jirakittidul, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Ovulation Inhibition Drug: Zoely Drug: Meliane ED Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two intervention groups
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception Containing Estradiol Hemihydrate Compared to Ethinyl Estradiol
Actual Study Start Date : January 21, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

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 Name: 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 Name: estradiol hemihydrate combined pills

Primary Outcome Measures :
  1. ovulation inhibition [ Time Frame: 1 month ]
    comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting

Secondary Outcome Measures :
  1. follicular development [ Time Frame: through study completion, an average of 1 month ]
    pattern of ovarian follicular change after receive intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03077555

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Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University

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Responsible Party: Preeyaporn Jirakittidul, Principle investigator, Mahidol University Identifier: NCT03077555    
Other Study ID Numbers: Si804/2016
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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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
Keywords provided by Preeyaporn Jirakittidul, Mahidol University:
quick starting contraception
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female