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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

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.

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Detailed Description

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Conditions

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Emergency Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ellaOne + microgynon 30

Group Type EXPERIMENTAL

Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)

Intervention Type DRUG

UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

placebo + microgynon 30

Group Type PLACEBO_COMPARATOR

placebo + ethinylestradiol/levonorgestrel

Intervention Type DRUG

placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

Interventions

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Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)

UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

Intervention Type DRUG

placebo + ethinylestradiol/levonorgestrel

placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

Intervention Type DRUG

Other Intervention Names

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ellaOne + Microgynon 30 Microgynon 30

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes