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OpenTrials
Completed

NCT Number: NCT01569113

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

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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Key information

Conditions

Emergency Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dinox, Groningen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Other names: ellaOne + Microgynon 30

placebo + ethinylestradiol/levonorgestrel

Drug

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

Other names: Microgynon 30

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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