Skip to main content
OpenTrials
Completed

NCT Number: NCT00411684

Safety and Efficacy of CDB-2914 for Emergency Contraception

The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emergency Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Planned Parenthood of Mar Monte, San Jose, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or more
  • Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
  • Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
  • No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
  • For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
  • Willing to not use hormonal methods of contraception until study completion
  • At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
  • Able to provide informed consent in English
  • Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
  • Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained

Exclusion criteria

  • One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
  • All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
  • Currently pregnant as confirmed by positive HSUP test performed at screening
  • Currently breast-feeding
  • Current use of hormonal contraception
  • 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
  • Currently enrolled in any other trial of an investigational medicine

Treatment and study plan

CDB-2914

Drug

Primary outcomes

  1. Pregnancy Rate

    Time frame: Up to 60 days after enrollment

    A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points:

    • 5-7 days after expected date of menses
    • 1 week later
    • every two week after

Secondary outcomes

  1. Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)

    Time frame: within the menstrual cycle of the unprotected Intercourse

    Number of prevented pregnancies divided by the number of expected pregnancies

  2. Impact on Menstrual Bleeding Patterns

    Time frame: within the menstrual cycle of the unprotected Intercourse

    Menstrual cycle length post treatment

  3. Frequencies of Subjects With Treatment Emergent Adverse Events

    Time frame: 12-14 days after expected menses

    Most common related adverse events in ITT population.

Sponsors and collaborators

Lead sponsor

HRA Pharma

Industry

Registry information

Official study title

A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 14, 2006
Registry last updated
Sep 21, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.