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

Primary Purpose

Emergency Contraception

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
placebo + ethinylestradiol/levonorgestrel
Sponsored by
HRA Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergency Contraception focused on measuring ella, ellaOne, quickstart, contraception, combined oral pill, microgynon

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Dinox
  • Karolinska University Hospital Solna
  • Chalmers Sexual Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ellaOne + microgynon 30

placebo + microgynon 30

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.

Full Information

First Posted
March 30, 2012
Last Updated
June 12, 2013
Sponsor
HRA Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01569113
Brief Title
Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HRA Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Contraception
Keywords
ella, ellaOne, quickstart, contraception, combined oral pill, microgynon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ellaOne + microgynon 30
Arm Type
Experimental
Arm Title
placebo + microgynon 30
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
Other Intervention Name(s)
ellaOne + Microgynon 30
Intervention Description
UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
Intervention Type
Drug
Intervention Name(s)
placebo + ethinylestradiol/levonorgestrel
Other Intervention Name(s)
Microgynon 30
Intervention Description
placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Cameron, MD
Organizational Affiliation
Chalmers Sexual Health Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dinox
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Chalmers Sexual Health Clinic
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH3 9ES
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25994664
Citation
Cameron ST, Berger C, Michie L, Klipping C, Gemzell-Danielsson K. The effects on ovarian activity of ulipristal acetate when 'quickstarting' a combined oral contraceptive pill: a prospective, randomized, double-blind parallel-arm, placebo-controlled study. Hum Reprod. 2015 Jul;30(7):1566-72. doi: 10.1093/humrep/dev115. Epub 2015 May 20.
Results Reference
derived

Learn more about this trial

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

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