Emergency Contraception
Conditions
Keywords
emergency contraception, antiprogestin
Brief summary
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.
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.
Interventions
DRUGCDB-2914
DRUGlevonorgestrel
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy (efficacy) | until follow-up about one week after next menses |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability (side effects) | until follow-up about one week after next menses |
| Menstrual cycle effects | until follow-up about one week after next menses |
Countries
United States
Outcome results
None listed