Phase 3
N=2,221
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00551616 ↗Enrolled (actual)
2,221
Serious AEs
0.3%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Pregnancy — 20; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CDB-2914 (Drug); Levonorgestrel (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- HRA Pharma
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pregnancy |
20; 30 | — |
| SECONDARY Actual Pregnancy Rate Compared to Expected Pregnancy Rate |
15; 22; 47; 46 | <0.001 sig |
| SECONDARY Menstrual Bleeding Patterns |
2.1; -1.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00551616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.