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Study 31 of 60 for search of: | nichd (Reproductive Health) |
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Sponsors and Collaborators: |
University of Pittsburgh Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00271583 |
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 |
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 |
Enrollment: | 1672 |
Study Start Date: | September 1999 |
Study Completion Date: | September 2001 |
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.
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 |
Principal Investigator: | Diana Blithe, PhD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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 |
emergency contraception antiprogestin |
Levonorgestrel Emergencies |
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 |