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

Phase 4

Completed

• Conditions: Emergency Contraception
• Interventions: Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon); Drug: placebo + ethinylestradiol/levonorgestrel

• Registration Number: NCT01569113
• Lead Sponsor: HRA Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ellaOne + microgynon 30	Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)	-
placebo + microgynon 30	placebo + ethinylestradiol/levonorgestrel	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Dinox; 🇳🇱 Groningen, Netherlands

Chalmers Sexual Health Clinic; 🇬🇧 Edinburgh, Scotland, United Kingdom

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden