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

This study has been completed.
Sponsor:
Information provided by:
HRA Pharma
ClinicalTrials.gov Identifier:
NCT00551616
First received: October 30, 2007
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: CDB-2914
Drug: Levonorgestrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • Pregnancy rate

Secondary Outcome Measures:
  • Prevented fraction (number of prevented pregnancies divided by number of expected pregnancies)
  • Menstrual bleeding patterns
  • Frequencies of subjects with treatment emergent adverse events

Enrollment: 2321
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CDB-2914
Single dose
Active Comparator: 2 Drug: Levonorgestrel
Single dose

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 IUD 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551616

Locations
United States, California
Planned Parenthood Hollywood
Los Angeles, California, United States
Planned Parenthood Santa Monica
Santa Monica, California, United States
United States, Colorado
Planned Parenthood of the Rocky Mountains
Boulder, Colorado, United States
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States
Planned Parenthood of the Rocky Mountains
Littleton, Colorado, United States
United States, Florida
Planned Parenthood of Greater Miami
Lake Worth, Florida, United States
Planned Parenthood of Greater Miami
Miami, Florida, United States
Planned Parenthood of Greater Miami
North Miami, Florida, United States
Planned Parenthood of Greater Miami
Stuart, Florida, United States
Planned Parenthood of Greater Miami
West Palm Beach, Florida, United States
United States, Ohio
Planned Parenthood of Northeast Ohio Akron Health Center
Akron, Ohio, United States
Planned Parenthood of Northeast Ohio Bedford Health Center
Bedford, Ohio, United States
Planned Parenthood of Northeast Ohio East Cleveland Health Center
Cleveland, Ohio, United States
Planned Parenthood of Northeast Ohio Old Brooklyn Health Center
Cleveland, Ohio, United States
Planned Parenthood of Northeast Ohio Kent Health Center
Kent, Ohio, United States
Planned Parenthood of Northeast Ohio Rocky River Health Center
Rocky River, Ohio, United States
United States, Texas
Planned Parenthood of Texas Capitol Region
Austin, Texas, United States
Planned Parenthood of Houston and Southeast Texas Research Department
Houston, Texas, United States
Fannin Health Center
Houston, Texas, United States
United States, Utah
Planned Parenthood Association of Utah
Ogden, Utah, United States
Planned Parenthood Association of Utah
Orem, Utah, United States
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States
Planned Parenthood Association of Utah
West Valley City, Utah, United States
Ireland
Well Woman Centre
Dublin, Ireland
United Kingdom
NHS Grampian Sexual and Reproductive Health
Aberdeen, United Kingdom
Brook Family Planning Clinic
Belfast, United Kingdom
NHS Lothian Family Planning Service
Edinburgh, United Kingdom
NHS Greater Glasgow & Clyde Family Planning Service
Glasgow, United Kingdom
Liverpool PCT Family Planning Services
Liverpool, United Kingdom
London Sexual and Reproductive Health
London, United Kingdom
Manchester Primary Care Trust
Manchester, United Kingdom
Nottingham Contraception & Sexual Health Service
Nottingham, United Kingdom
Oxfordshire PCT Community Health
Oxford, United Kingdom
Sponsors and Collaborators
HRA Pharma
Investigators
Principal Investigator: Anna F Glasier, MD NHS Lothian Family Planning Service
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00551616     History of Changes
Other Study ID Numbers: 2914-004
Study First Received: October 30, 2007
Last Updated: June 16, 2010
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 23, 2014