Safety and Efficacy of CDB-2914 for Emergency Contraception

• Sponsor: HRA Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00411684
• Collaborator: (none)
• Enrollment: 1,623
• Locations: 17
• Arm: 1
• Duration (Months): 31.1
• Patients Per Site: 95.5
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Emergency Contraception	Drug: CDB-2914	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1623 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2006
• Actual Primary Completion Date: Apr 8, 2008
• Actual Study Completion Date: Jun 5, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDB-2914 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Impact on Menstrual Bleeding Patterns [within the menstrual cycle of the unprotected Intercourse]

   Menstrual cycle length post treatment

3. Frequencies of Subjects With Treatment Emergent Adverse Events [12-14 days after expected menses]

   Most common related adverse events in ITT population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of Mar Monte	San Jose	California	United States	95126
2	Planned Parenthood of the Rocky Mountains	Denver	Colorado	United States	80203
3	Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost	Miami	Florida	United States
4	Planned Parenthood of South Palm Beach, Pembroke Pines	Pembroke Pines	Florida	United States
5	Planned Parenthood of Indiana	Bloomington	Indiana	United States
6	Planned Parenthood of Greater Iowa	Ames	Iowa	United States
7	Planned Parenthood of Maryland	Baltimore	Maryland	United States	21201
8	Planned Parenthood League of Massachusetts	Boston	Massachusetts	United States	02215
9	Planned Parenthood of Mid-Michigan Alliance	Ann Arbor	Michigan	United States
10	Planned Parenthood of Minnesota	Minneapolis	Minnesota	United States
11	Planned Parenthood of Greater Cleveland	Cleveland	Ohio	United States
12	Planned Parenthood of Columbia-Willamette	Portland	Oregon	United States	97206
13	Planned Parenthood of SE Philadelphia	Philadelphia	Pennsylvania	United States
14	Planned Parenthood of the Texas Capital Region	Austin	Texas	United States
15	Planned Parenthood of Houston and Southeast Texas	Houston	Texas	United States	77004
16	Planned Parenthood Association of Utah	Salt Lake City	Utah	United States
17	Planned Parenthood of Western Washington	Seattle	Washington	United States	98122

Sponsors and Collaborators

• HRA Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HRA Pharma
• ClinicalTrials.gov Identifier: NCT00411684
• Other Study ID Numbers: 2914-005
• First Posted: Dec 14, 2006
• Last Update Posted: Sep 21, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Emergencies; Ulipristal acetate

Study Results

Participant Flow

Pre-assignment Detail	Screening 1623 Screening failures 90 Enrolled 1533

Arm/Group Title	CDB-2914
Arm/Group 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 CDB-2914
Period Title: Overall Study
STARTED	1533
COMPLETED	1241
NOT COMPLETED	292

Baseline Characteristics

Arm/Group Title	Exp Arm
Arm/Group 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 CDB-2914
Overall Participants	1533
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1533 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.4 (6.1)
Sex: Female, Male (Count of Participants)
Female	1533 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	338 22%
Not Hispanic or Latino	1182 77.1%
Unknown or Not Reported	13 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	21 1.4%
Asian	35 2.3%
Native Hawaiian or Other Pacific Islander	11 0.7%
Black or African American	328 21.4%
White	921 60.1%
More than one race	212 13.8%
Unknown or Not Reported	5 0.3%
Region of Enrollment (participants) [Number]
United States	1533 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Primary efficacy population

Arm/Group Title	CDB-2914
Arm/Group 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 CDB-2914
Measure Participants	1241
Number (95% Confidence Interval) [percentage of participants]	2.1 0.1%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Primary efficacy population

Arm/Group Title	CDB-2914
Arm/Group 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 CDB-2914
Measure Participants	1241
Number (95% Confidence Interval) [percentage of participants]	62.3 4.1%

3. Secondary Outcome

Title	Impact on Menstrual Bleeding Patterns
Description	Menstrual cycle length post treatment
Time Frame	within the menstrual cycle of the unprotected Intercourse

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	CDB-2914
Arm/Group 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 CDB-2914
Measure Participants	1533
Mean (Standard Deviation) [Days]	31.8 (10.2)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	CDB-2914
Arm/Group 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 CDB-2914
Measure Participants	1533
Headache	9.3 0.6%
Nausea	9.2 0.6%
Abdominal pain	6.8 0.4%
Dysmenorrhea	4.1 0.3%
Dizziness	3.5 0.2%
Fatigue	3.4 0.2%

Adverse Events

Arm/Group Title	CDB-2914
Arm/Group 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 CDB-2914
All Cause Mortality
	CDB-2914
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CDB-2914
	Affected / at Risk (%)	# Events
Total	1/1533 (0.1%)
Nervous system disorders
Seizure	1/1533 (0.1%)	3
Other (Not Including Serious) Adverse Events
	CDB-2914
	Affected / at Risk (%)	# Events
Total	557/1533 (36.3%)
Gastrointestinal disorders
Nausea	141/1533 (9.2%)	141
Abdominal pain	104/1533 (6.8%)	104
General disorders
Fatigue	52/1533 (3.4%)	52
Nervous system disorders
Headache	143/1533 (9.3%)	143
Dizziness	54/1533 (3.5%)	54
Reproductive system and breast disorders
Dysmenorrhea	63/1533 (4.1%)	63

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.