Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
NCT ID: NCT00551616
Last Updated: 2022-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2221 participants
INTERVENTIONAL
2007-04-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CDB-2914
CDB-2914
Single dose
Levonorgestrel
Levonorgestrel
Single dose
Interventions
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CDB-2914
Single dose
Levonorgestrel
Single dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
FEMALE
No
Sponsors
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HRA Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Anna F Glasier, MD
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian Family Planning Service
Locations
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Planned Parenthood Hollywood
Los Angeles, California, United States
Planned Parenthood Santa Monica
Santa Monica, California, United States
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
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
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
Planned Parenthood of Texas Capitol Region
Austin, Texas, United States
Fannin Health Center
Houston, Texas, United States
Planned Parenthood of Houston and Southeast Texas Research Department
Houston, Texas, United States
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
Well Woman Centre
Dublin, , Ireland
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
Countries
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References
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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. doi: 10.1016/S0140-6736(10)60101-8. Epub 2010 Jan 29.
Other Identifiers
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2914-004
Identifier Type: -
Identifier Source: org_study_id
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