Clinical trial NCT00411684: Safety and Efficacy of CDB-2914 for Emergency Contraception
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Emergency Contraception
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 1623
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Rate
timeFrame: Up to 60 days after enrollment
Secondary outcomes:
measure: Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
timeFrame: within the menstrual cycle of the unprotected Intercourse
measure: Impact on Menstrual Bleeding Patterns
timeFrame: within the menstrual cycle of the unprotected Intercourse
measure: Frequencies of Subjects With Treatment Emergent Adverse Events
timeFrame: 12-14 days after expected menses
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Planned Parenthood of Mar Monte
state: California
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Miami
country: United States
facility: Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
state: Florida
city: Pembroke Pines
country: United States
facility: Planned Parenthood of South Palm Beach, Pembroke Pines
state: Florida
city: Bloomington
country: United States
facility: Planned Parenthood of Indiana
state: Indiana
city: Ames
country: United States
facility: Planned Parenthood of Greater Iowa
state: Iowa
city: Baltimore
country: United States
facility: Planned Parenthood of Maryland
state: Maryland
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: Planned Parenthood of Mid-Michigan Alliance
state: Michigan
city: Minneapolis
country: United States
facility: Planned Parenthood of Minnesota
state: Minnesota
city: Cleveland
country: United States
facility: Planned Parenthood of Greater Cleveland
state: Ohio
city: Portland
country: United States
facility: Planned Parenthood of Columbia-Willamette
state: Oregon
city: Philadelphia
country: United States
facility: Planned Parenthood of SE Philadelphia
state: Pennsylvania
city: Austin
country: United States
facility: Planned Parenthood of the Texas Capital Region
state: Texas
city: Houston
country: United States
facility: Planned Parenthood of Houston and Southeast Texas
state: Texas
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Seattle
country: United States
facility: Planned Parenthood of Western Washington
state: Washington
Study officials:
affiliation: Planned Parenthood of Houston and Southeast Texas
name: Paul Fine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.