Efficacy Trial of CDB 2914 for Emergency Contraception - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00271583

Purpose

Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.

Condition	Intervention	Phase
Emergency Contraception	Drug: CDB-2914 Drug: levonorgestrel	Phase II Phase III

MedlinePlus related topics: Birth Control Menstruation

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Pregnancy (efficacy) [ Time Frame: until follow-up about one week after next menses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability (side effects) [ Time Frame: until follow-up about one week after next menses ]
Menstrual cycle effects [ Time Frame: until follow-up about one week after next menses ]

Enrollment:	1672
Study Start Date:	September 1999
Study Completion Date:	September 2001

Detailed Description:

Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Duration: A one-time treatment with either CDB-2914 or levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

Treatment: A one-time treatment with one of the following:

Two doses of 0.75 mg of levonorgestrel to be taken 12 hours apart
One dose of 50 mg CDB-2914 and a second placebo dose to be taken 12 hours later

Study Sites: Multicenter study in the United States

Subjects: Women of reproductive age (at least 18 years) at risk of pregnancy within 72 hours of unprotected coitus

Sample Size: Approximately 811 women will be enrolled in each treatment group to obtain 1540 evaluable subjects

Outcome Evaluations

Primary: To evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.

Secondary: To compare the tolerability (as measured by vomiting and nausea) of CDB-2914 used by subjects as an emergency postcoital contraceptive with that of a group of subjects receiving levonorgestrel.

Safety/Other: To assess the frequency and intensity of adverse events and the effects on the menstrual cycle of subjects administered CDB-2914 in comparison to subjects given levonorgestrel.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Menstruating women at least 18 years old;
Give voluntary, written informed consent, and agree to observe all study requirements;
Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
Willing to abstain from further acts of unprotected intercourse during that cycle;
History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
At least one normal menstrual cycle (2 menses) post delivery or abortion;
If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
Available for follow-up for at least the next four weeks.

Exclusion Criteria:

Currently pregnant (positive high-sensitivity urine pregnancy test);
pregnant or breast-feeding within the past two months;
use of hormonal methods of contraception during the current or previous two cycles;
current user of IUD;
tubal ligation;
partners with history of vasectomy;
unsure about the date of the last menstrual period (+3 days);
irregular menstrual cycles as defined in the inclusion criteria;
nausea and vomiting within the previous two weeks;
impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.

Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271583

Locations

United States, California
California Family Health Council
Los Angeles, California, United States
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, New York
New York University
New York, New York, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15215
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States

Sponsors and Collaborators

University of Pittsburgh

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Diana Blithe, PhD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Publications of Results:

Creinin MD, Schlaff W, Archer DF, Wan L, Frezieres R, Thomas M, Rosenberg M, Higgins J. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1089-97.

Study ID Numbers:	CCN002, N01-HD-9-3298
Study First Received:	December 29, 2005
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00271583
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

emergency contraception
antiprogestin

Study placed in the following topic categories:

Levonorgestrel
Emergencies

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral

Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009