Safety and Efficacy of CDB-2914 for Emergency Contraception

• CDB-2914 (Drug)

Primary outcomes

• Pregnancy Rate [Up to 60 days after enrollment]: A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after

Secondary outcomes

• Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies) [within the menstrual cycle of the unprotected Intercourse]: Number of prevented pregnancies divided by the number of expected pregnancies
• Impact on Menstrual Bleeding Patterns [within the menstrual cycle of the unprotected Intercourse]: Menstrual cycle length post treatment
• Frequencies of Subjects With Treatment Emergent Adverse Events [12-14 days after expected menses]: Most common related adverse events in ITT population.

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Aged 18 years or more
* Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
* Request emergency contraception between 48 hours and 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 delivery, miscarriage or abortion
* 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

Exclusion Criteria:

* One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
* All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
* Currently pregnant as confirmed by positive HSUP test performed at screening
* 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 an investigational medicine

Participant flow

Outcome results

• Pregnancy Rate (Primary), Number, percentage of participants: CDB-2914 2.1 (1.4 to 3.1)
• Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies) (Secondary), Number, percentage of participants: CDB-2914 62.3 (41.9 to 75.6)
• Impact on Menstrual Bleeding Patterns (Secondary), Mean, Days: CDB-2914 31.8 +/- 10.2
• Frequencies of Subjects With Treatment Emergent Adverse Events (Secondary), Number, percentage of participants: CDB-2914 9.3

Adverse events

Serious adverse events by term

Other adverse events by term

• Results publication: Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol. 2010 Feb;115(2 Pt 1):257-263. doi: 10.1097/AOG.0b013e3181c8e2aa. PMID 20093897

• Paul Fine, MD, Principal investigator, Planned Parenthood of Houston and Southeast Texas