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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Emergency Contraception

Intervention / Treatment
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* Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
* Drug: placebo + ethinylestradiol/levonorgestrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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). |  | Day 1 to day 21 of intake of microgynon 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ella, ellaOne, quickstart, contraception, combined oral pill, microgynon