Safety and Efficacy of CDB-2914 for Emergency Contraception
NCT ID: NCT00411684
Last Updated: 2021-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1623 participants
INTERVENTIONAL
2006-11-30
2009-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDB-2914
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
CDB-2914
Interventions
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CDB-2914
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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HRA Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Fine, MD
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood of Houston and Southeast Texas
Locations
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Planned Parenthood of Mar Monte
San Jose, California, United States
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States
Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
Miami, Florida, United States
Planned Parenthood of South Palm Beach, Pembroke Pines
Pembroke Pines, Florida, United States
Planned Parenthood of Indiana
Bloomington, Indiana, United States
Planned Parenthood of Greater Iowa
Ames, Iowa, United States
Planned Parenthood of Maryland
Baltimore, Maryland, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Planned Parenthood of Mid-Michigan Alliance
Ann Arbor, Michigan, United States
Planned Parenthood of Minnesota
Minneapolis, Minnesota, United States
Planned Parenthood of Greater Cleveland
Cleveland, Ohio, United States
Planned Parenthood of Columbia-Willamette
Portland, Oregon, United States
Planned Parenthood of SE Philadelphia
Philadelphia, Pennsylvania, United States
Planned Parenthood of the Texas Capital Region
Austin, Texas, United States
Planned Parenthood of Houston and Southeast Texas
Houston, Texas, United States
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States
Planned Parenthood of Western Washington
Seattle, Washington, United States
Countries
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References
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Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa.
Other Identifiers
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2914-005
Identifier Type: -
Identifier Source: org_study_id
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