Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,221

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2007

Geographic Reach

3 countries

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

April 1, 2007

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

13 years until next milestone

Results Posted

Study results publicly available

March 16, 2022

Completed

Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

October 30, 2007

Results QC Date

February 16, 2022

Last Update Submit

April 11, 2022

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

Number of Participants With Pregnancy
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Within 72 hours of unprotected Intercourse

Secondary Outcomes (2)

Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Within 120 hours of unprotected Intercourse
Menstrual Bleeding Patterns
within the menstrual cycle of the unprotected Intercourse

Study Arms (2)

CDB-2914

EXPERIMENTAL

Drug: CDB-2914

Levonorgestrel

ACTIVE COMPARATOR

Drug: Levonorgestrel

Interventions

CDB-2914DRUG

Single dose

CDB-2914

LevonorgestrelDRUG

Single dose

Levonorgestrel

Eligibility Criteria

Age16 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

HRA Pharmalead

Study Sites (33)

Planned Parenthood Hollywood

Los Angeles, California, United States

Location

Planned Parenthood Santa Monica

Santa Monica, California, United States

Location

Planned Parenthood of the Rocky Mountains

Boulder, Colorado, United States

Location

Planned Parenthood of the Rocky Mountains

Denver, Colorado, United States

Location

Planned Parenthood of the Rocky Mountains

Littleton, Colorado, United States

Location