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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
History of Changes

October 30, 2007
June 16, 2010
April 2007
April 2009   (final data collection date for primary outcome measure)
Pregnancy rate
Same as current
Complete list of historical versions of study NCT00551616 on ClinicalTrials.gov Archive Site
  • Prevented fraction (number of prevented pregnancies divided by number of expected pregnancies)
  • Menstrual bleeding patterns
  • Frequencies of subjects with treatment emergent adverse events
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Not Provided

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Contraception
  • Drug: CDB-2914
    Single dose
  • Drug: Levonorgestrel
    Single dose
  • Experimental: 1
    Intervention: Drug: CDB-2914
  • Active Comparator: 2
    Intervention: Drug: Levonorgestrel
Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010 Feb 13;375(9714):555-62. Epub 2010 Jan 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2321
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Female
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Ireland,   United Kingdom
 
NCT00551616
2914-004
Yes
Not Provided
HRA Pharma
Not Provided
Principal Investigator: Anna F Glasier, MD NHS Lothian Family Planning Service
HRA Pharma
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP