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

HRA Pharma76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Emergency Contraception

Interventions

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

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

placebo + ethinylestradiol/levonorgestrelDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (3)

Dinox

Groningen, Netherlands

Karolinska University Hospital Solna

Stockholm, Sweden

Chalmers Sexual Health Clinic

Edinburgh, Scotland, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: Day 1 to day 21 of intake of microgynon 30

Secondary Outcomes

Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.

Time frame: Day 1 to day 21 of intake of microgynon 30

Data from ClinicalTrials.gov

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