Emergency contraception
Conditions
Interventions
Product Code: CBD-2914
Pharmaceutical Form: Tablet
INN or Proposed INN: ULIPRISTAL (proposed)
CAS Number: 126784-99-4
Current Sponsor code: VA 2914
Other descriptive name: RTI-3021-012 (previous code)
Sponsors
Laboratoire HRA Pharma
Eligibility
Sex/Gender
All
Inclusion 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 5 days; - Request emergency contraception within 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 miscarriage, delivery or abortion; - For women who present more than 72 hours after intercourse, decline the insertion of an IUD for emergency contraception and/or have contraindications to IUD insertion; - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - One or more acts of unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle; - Currently pregnant as confirmed by positive HSUP test performed at screening (Treatment Visit); - 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 investigational medicine - hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the pregnancy rate observed after taking CDB-2914 30 mg within 72 hours of unprotected intercourse is statistically significantly lower than the expected pregnancy rate in the absence of emergency contraception.;Secondary Objective: - To demonstrate that the pregnancy rate observed after taking CDB-2914 30 mg within 72 hours/120 hours of unprotected intercourse is statistically significantly lower than 4% considered as a clinical irrelevance threshold -To demonstrate the non-inferiority of CDB-2914 30 mg versus LNG1.5 mg as emergency contraception within 72 hours/120 hours of unprotected intercourse; - To demonstrate that the pregnancy rate observed after taking CDB-2914 30mg within 120 hours of unprotected intercourse is statistically significantly lower than the expected pregnancy rate in the absence of emergency contraception; - To compare the trend in pregnancy rates over time since intercourse of CDB-2914 30 mg to LNG 1.5mg; - To compare the contraceptive effectiveness (prevented fraction) between treatment groups; - To assess the impact of CDB-2914 30mg on menstrual cycle compared to LNG; - To evaluate safety and tolerability profile of CDB-2914 30mg in comparison to LNG 1.5 mg. ;Primary end point(s): The primary efficacy parameter is the pregnancy rate calculated as the number of subjects being pregnant after the intake of emergency contraception, divided by the number of subjects having received emergency contraception. Subjects with pregnancies not detected at screening but identified as having started before emergency contraception intake (as measured by pre-treatment serum bêta- hCG level assayed once pregnancy diagnosis has been made and gestational age confirmed by transvaginal ultrasound) or as “not compatible” with an emergency contraception failure, based on independent evaluation will be excluded from efficacy analysis. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed