NCT03077555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

March 2, 2017

Last Update Submit

March 21, 2018

Conditions

Ovulation Inhibition

Keywords

quick starting contraception

Outcome Measures

Primary Outcomes (1)

  • ovulation inhibition

    comparison of ovulation inhibition effect between Zoely and Meliane ED with mid follicular phase starting

    1 month

Secondary Outcomes (1)

  • follicular development

    through study completion, an average of 1 month

Study Arms (2)

Meliane ED

ACTIVE COMPARATOR

20 mcg ethinyl estradiol/70 mcg gestodene

Drug: Meliane ED

Zoely

EXPERIMENTAL

1.5 mg estradiol/2.5 mg nomegestrol acetate

Drug: Zoely

Interventions

ZoelyDRUG

quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate

Also known as: estradiol hemihydrate combined pills
Zoely
Meliane EDDRUG

quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene

Also known as: ethinyl estradiol combined pills
Meliane ED

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women, age 18 - 40 years
  • prior normal and regular interval of menstruation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: two intervention groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 13, 2017

Study Start

January 21, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

TH(1)