Clinical trial NCT00551616: Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-31
Enrollment: 2221
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 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:

* 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

Primary outcomes:
measure: Number of Participants With Pregnancy
timeFrame: Within 72 hours of unprotected Intercourse
Secondary outcomes:
measure: Actual Pregnancy Rate Compared to Expected Pregnancy Rate
timeFrame: Within 120 hours of unprotected Intercourse
measure: Menstrual Bleeding Patterns
timeFrame: within the menstrual cycle of the unprotected Intercourse
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Planned Parenthood Hollywood
state: California
city: Santa Monica
country: United States
facility: Planned Parenthood Santa Monica
state: California
city: Boulder
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Littleton
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Lake Worth
country: United States
facility: Planned Parenthood of Greater Miami
state: Florida
city: Miami
country: United States
facility: Planned Parenthood of Greater Miami
state: Florida
city: North Miami
country: United States
facility: Planned Parenthood of Greater Miami
state: Florida
city: Stuart
country: United States
facility: Planned Parenthood of Greater Miami
state: Florida
city: West Palm Beach
country: United States
facility: Planned Parenthood of Greater Miami
state: Florida
city: Akron
country: United States
facility: Planned Parenthood of Northeast Ohio Akron Health Center
state: Ohio
city: Bedford
country: United States
facility: Planned Parenthood of Northeast Ohio Bedford Health Center
state: Ohio
city: Cleveland
country: United States
facility: Planned Parenthood of Northeast Ohio East Cleveland Health Center
state: Ohio
city: Cleveland
country: United States
facility: Planned Parenthood of Northeast Ohio Old Brooklyn Health Center
state: Ohio
city: Kent
country: United States
facility: Planned Parenthood of Northeast Ohio Kent Health Center
state: Ohio
city: Rocky River
country: United States
facility: Planned Parenthood of Northeast Ohio Rocky River Health Center
state: Ohio
city: Austin
country: United States
facility: Planned Parenthood of Texas Capitol Region
state: Texas
city: Houston
country: United States
facility: Fannin Health Center
state: Texas
city: Houston
country: United States
facility: Planned Parenthood of Houston and Southeast Texas Research Department
state: Texas
city: Ogden
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Orem
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: West Valley City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Dublin
country: Ireland
facility: Well Woman Centre
city: Aberdeen
country: United Kingdom
facility: NHS Grampian Sexual and Reproductive Health
city: Belfast
country: United Kingdom
facility: Brook Family Planning Clinic
city: Edinburgh
country: United Kingdom
facility: NHS Lothian Family Planning Service
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow & Clyde Family Planning Service
city: Liverpool
country: United Kingdom
facility: Liverpool PCT Family Planning Services
city: London
country: United Kingdom
facility: London Sexual and Reproductive Health
city: Manchester
country: United Kingdom
facility: Manchester Primary Care Trust
city: Nottingham
country: United Kingdom
facility: Nottingham Contraception & Sexual Health Service
city: Oxford
country: United Kingdom
facility: Oxfordshire PCT Community Health
Study officials:
affiliation: NHS Lothian Family Planning Service
name: Anna F Glasier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.