Phase 3
Completed N=2,221
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Source: ClinicalTrials.gov NCT00551616 ↗Enrolled (actual)
2,221
Serious AEs
0.3%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Pregnancy — 20; 30 Participants
◆ Published Evidence
Highly cited
526citations · ~33 / year
Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis.
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.
Linked Publications
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Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.