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Safety and Efficacy of CDB-2914 for Emergency Contraception

Primary Purpose

Emergency Contraception

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CDB-2914
Sponsored by
HRA Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergency Contraception

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Planned Parenthood of Mar Monte
  • Planned Parenthood of the Rocky Mountains
  • Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
  • Planned Parenthood of South Palm Beach, Pembroke Pines
  • Planned Parenthood of Indiana
  • Planned Parenthood of Greater Iowa
  • Planned Parenthood of Maryland
  • Planned Parenthood League of Massachusetts
  • Planned Parenthood of Mid-Michigan Alliance
  • Planned Parenthood of Minnesota
  • Planned Parenthood of Greater Cleveland
  • Planned Parenthood of Columbia-Willamette
  • Planned Parenthood of SE Philadelphia
  • Planned Parenthood of the Texas Capital Region
  • Planned Parenthood of Houston and Southeast Texas
  • Planned Parenthood Association of Utah
  • Planned Parenthood of Western Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDB-2914

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Number of prevented pregnancies divided by the number of expected pregnancies
Impact on Menstrual Bleeding Patterns
Menstrual cycle length post treatment
Frequencies of Subjects With Treatment Emergent Adverse Events
Most common related adverse events in ITT population.

Full Information

First Posted
December 13, 2006
Last Updated
August 27, 2021
Sponsor
HRA Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00411684
Brief Title
Safety and Efficacy of CDB-2914 for Emergency Contraception
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 8, 2008 (Actual)
Study Completion Date
June 5, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HRA Pharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Contraception

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDB-2914
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CDB-2914
Primary Outcome Measure Information:
Title
Pregnancy Rate
Description
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
Time Frame
Up to 60 days after enrollment
Secondary Outcome Measure Information:
Title
Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
Description
Number of prevented pregnancies divided by the number of expected pregnancies
Time Frame
within the menstrual cycle of the unprotected Intercourse
Title
Impact on Menstrual Bleeding Patterns
Description
Menstrual cycle length post treatment
Time Frame
within the menstrual cycle of the unprotected Intercourse
Title
Frequencies of Subjects With Treatment Emergent Adverse Events
Description
Most common related adverse events in ITT population.
Time Frame
12-14 days after expected menses

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Fine, MD
Organizational Affiliation
Planned Parenthood of Houston and Southeast Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood of Mar Monte
City
San Jose
State/Province
California
ZIP/Postal Code
95126
Country
United States
Facility Name
Planned Parenthood of the Rocky Mountains
City
Denver
State/Province
Colorado
ZIP/Postal Code
80203
Country
United States
Facility Name
Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
City
Miami
State/Province
Florida
Country
United States
Facility Name
Planned Parenthood of South Palm Beach, Pembroke Pines
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Planned Parenthood of Indiana
City
Bloomington
State/Province
Indiana
Country
United States
Facility Name
Planned Parenthood of Greater Iowa
City
Ames
State/Province
Iowa
Country
United States
Facility Name
Planned Parenthood of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Planned Parenthood League of Massachusetts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Planned Parenthood of Mid-Michigan Alliance
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Planned Parenthood of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Planned Parenthood of Greater Cleveland
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Planned Parenthood of Columbia-Willamette
City
Portland
State/Province
Oregon
ZIP/Postal Code
97206
Country
United States
Facility Name
Planned Parenthood of SE Philadelphia
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Planned Parenthood of the Texas Capital Region
City
Austin
State/Province
Texas
Country
United States
Facility Name
Planned Parenthood of Houston and Southeast Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Planned Parenthood Association of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Planned Parenthood of Western Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20093897
Citation
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.
Results Reference
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Safety and Efficacy of CDB-2914 for Emergency Contraception

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