Safety and Efficacy of CDB-2914 for Emergency Contraception

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

Official Title
-----------------
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex

Conditions
-----------------
Emergency Contraception

Intervention / Treatment
-----------------
* Drug: CDB-2914


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDB-2914<br>A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse | Drug: CDB-2914<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | 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 | Up to 60 days after enrollment | 

Secondary Outcome Measures

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