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Completed

NCT Number: NCT00551616

Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.

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Key information

Conditions

Contraception

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Well Woman Centre, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
  • present within 120 hours of unprotected intercourse
  • regular menstrual cycles
  • No current use of hormonal contraception
  • Willing to not use hormonal methods of contraception until study completion
  • At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
  • For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
  • Able to provide informed consent
  • Willing to abstain from further acts of unprotected intercourse until study completion

Exclusion criteria

  • One or more acts of unprotected intercourse more than 120 hours
  • current or recent use of hormonal methods of contraception
  • currently pregnant or breastfeeding
  • tubal ligation or current use of IUD
  • Use of hormonal emergency contraception since last menstrual period
  • Current use of IUD
  • Tubal ligation
  • Partner with a vasectomy
  • Unsure about the date of the last menstrual period
  • Severe asthma insufficiently controlled by oral glucocorticoid
  • Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study

Treatment and study plan

CDB-2914

Drug

Single dose

Levonorgestrel

Drug

Single dose

Primary outcomes

  1. Number of Participants With Pregnancy

    Time frame: Within 72 hours of unprotected Intercourse

    The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.

Secondary outcomes

  1. Actual Pregnancy Rate Compared to Expected Pregnancy Rate

    Time frame: Within 120 hours of unprotected Intercourse

    Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone & Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.

  2. Menstrual Bleeding Patterns

    Time frame: within the menstrual cycle of the unprotected Intercourse

    Onset of next menses after emergency contraception compared to usual date.

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2007
Registry last updated
May 3, 2022

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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