Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.

June 12, 2013 updated by: HRA Pharma

A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo.

The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713
        • Dinox
  • Sweden
      • Stockholm, Sweden, SE-171 76
        • Karolinska University Hospital Solna
  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH3 9ES
        • Chalmers Sexual Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women aged 18-35 years old
  • BMI < 30 Kg/m2
  • Not at risk of pregnancy
  • No use of progesterone-only-pill for 3 months before start of treatment cycle
  • No use of implant hormonal contraception for 3 months before start of treatment cycle
  • No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
  • No use of depo provera for 12 months before start of treatment cycle
  • Able to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ellaOne + microgynon 30
Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
Other Names:
  • ellaOne + Microgynon 30
Placebo Comparator: placebo + microgynon 30
Drug: placebo + ethinylestradiol/levonorgestrel
placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
Other Names:
  • Microgynon 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).
Time Frame: Day 1 to day 21 of intake of microgynon 30
Day 1 to day 21 of intake of microgynon 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.
Time Frame: Day 1 to day 21 of intake of microgynon 30
Day 1 to day 21 of intake of microgynon 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HRA Pharma

Investigators

  • Principal Investigator: Sharon Cameron, MD, Chalmers Sexual Health Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2914-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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