Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
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.
1 other identifier
interventional
76
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJune 13, 2013
June 1, 2013
5 months
March 30, 2012
June 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Day 1 to day 21 of intake of microgynon 30
Secondary Outcomes (1)
Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.
Day 1 to day 21 of intake of microgynon 30
Study Arms (2)
ellaOne + microgynon 30
EXPERIMENTALplacebo + microgynon 30
PLACEBO COMPARATORInterventions
UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HRA Pharmalead
Study Sites (3)
Dinox
Groningen, 9713, Netherlands
Karolinska University Hospital Solna
Stockholm, SE-171 76, Sweden
Chalmers Sexual Health Clinic
Edinburgh, Scotland, EH3 9ES, United Kingdom
Related Publications (1)
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.
PMID: 25994664DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Cameron, MD
Chalmers Sexual Health Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 2, 2012
Study Start
March 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
June 13, 2013
Record last verified: 2013-06