Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
Information source: HRA Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Emergency Contraception
Intervention: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) (Drug); placebo + ethinylestradiol/levonorgestrel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: HRA Pharma Official(s) and/or principal investigator(s): Sharon Cameron, MD, Principal Investigator, Affiliation: Chalmers Sexual Health Clinic
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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: Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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.
Locations and Contacts
Dinox, Groningen 9713, Netherlands
Karolinska University Hospital Solna, Stockholm SE-171 76, Sweden
Chalmers Sexual Health Clinic, Edinburgh, Scotland EH3 9ES, United Kingdom
Additional Information
Starting date: March 2012
Last updated: June 12, 2013
|