Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

• Sponsor: HRA Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00551616
• Collaborator: (none)
• Enrollment: 2,221
• Locations: 33
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 67.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 2221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDB-2914	Drug: CDB-2914; Single dose
Active Comparator: Levonorgestrel	Drug: Levonorgestrel; Single dose

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Pregnancy [Within 72 hours of unprotected Intercourse]

   The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.

Secondary Outcome Measures

1. Actual Pregnancy Rate Compared to Expected Pregnancy Rate [Within 120 hours of unprotected Intercourse]

   Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone & Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.

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

   Onset of next menses after emergency contraception compared to usual date.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood Hollywood	Los Angeles	California	United States
2	Planned Parenthood Santa Monica	Santa Monica	California	United States
3	Planned Parenthood of the Rocky Mountains	Boulder	Colorado	United States
4	Planned Parenthood of the Rocky Mountains	Denver	Colorado	United States
5	Planned Parenthood of the Rocky Mountains	Littleton	Colorado	United States
6	Planned Parenthood of Greater Miami	Lake Worth	Florida	United States
7	Planned Parenthood of Greater Miami	Miami	Florida	United States
8	Planned Parenthood of Greater Miami	North Miami	Florida	United States
9	Planned Parenthood of Greater Miami	Stuart	Florida	United States
10	Planned Parenthood of Greater Miami	West Palm Beach	Florida	United States
11	Planned Parenthood of Northeast Ohio Akron Health Center	Akron	Ohio	United States
12	Planned Parenthood of Northeast Ohio Bedford Health Center	Bedford	Ohio	United States
13	Planned Parenthood of Northeast Ohio East Cleveland Health Center	Cleveland	Ohio	United States
14	Planned Parenthood of Northeast Ohio Old Brooklyn Health Center	Cleveland	Ohio	United States
15	Planned Parenthood of Northeast Ohio Kent Health Center	Kent	Ohio	United States
16	Planned Parenthood of Northeast Ohio Rocky River Health Center	Rocky River	Ohio	United States
17	Planned Parenthood of Texas Capitol Region	Austin	Texas	United States
18	Fannin Health Center	Houston	Texas	United States
19	Planned Parenthood of Houston and Southeast Texas Research Department	Houston	Texas	United States
20	Planned Parenthood Association of Utah	Ogden	Utah	United States
21	Planned Parenthood Association of Utah	Orem	Utah	United States
22	Planned Parenthood Association of Utah	Salt Lake City	Utah	United States
23	Planned Parenthood Association of Utah	West Valley City	Utah	United States
24	Well Woman Centre	Dublin		Ireland
25	NHS Grampian Sexual and Reproductive Health	Aberdeen		United Kingdom
26	Brook Family Planning Clinic	Belfast		United Kingdom
27	NHS Lothian Family Planning Service	Edinburgh		United Kingdom
28	NHS Greater Glasgow & Clyde Family Planning Service	Glasgow		United Kingdom
29	Liverpool PCT Family Planning Services	Liverpool		United Kingdom
30	London Sexual and Reproductive Health	London		United Kingdom
31	Manchester Primary Care Trust	Manchester		United Kingdom
32	Nottingham Contraception & Sexual Health Service	Nottingham		United Kingdom
33	Oxfordshire PCT Community Health	Oxford		United Kingdom

Sponsors and Collaborators

• HRA Pharma

Investigators

• Principal Investigator: Anna F Glasier, MD, NHS Lothian Family Planning Service

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HRA Pharma
• ClinicalTrials.gov Identifier: NCT00551616
• Other Study ID Numbers: 2914-004
• First Posted: Oct 31, 2007
• Last Update Posted: May 3, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Levonorgestrel

Study Results

Participant Flow

Arm/Group Title	CDB-2914	Levonorgestrel
Arm/Group Description	CDB-2914: Single dose (30 mg)	Levonorgestrel: Single dose (1.5 mg)
Period Title: Overall Study
STARTED	1104	1117
COMPLETED	1056	1077
NOT COMPLETED	48	40

Baseline Characteristics

Arm/Group Title	CDB-2914	Levonorgestrel	Total
Arm/Group Description	CDB-2914: Single dose (30 mg)	Levonorgestrel: Single dose (1.5 mg)	Total of all reporting groups
Overall Participants	1104	1117	2221
Age (Count of Participants)
<=18 years	44 4%	49 4.4%	93 4.2%
Between 18 and 65 years	1060 96%	1068 95.6%	2128 95.8%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.5 (6.1)	24.9 (6.5)	24.7 (6.3)
Sex: Female, Male (Count of Participants)
Female	1104 100%	1117 100%	2221 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	804 72.8%	809 72.4%	1613 72.6%
Black	210 19%	207 18.5%	417 18.8%
Asian	13 1.2%	21 1.9%	34 1.5%
Other	77 7%	80 7.2%	157 7.1%
Time from unprotected sexual intercourse to emergency contraception (hours) (Count of Participants)
0-24h	367 33.2%	395 35.4%	762 34.3%
25-48h	388 35.1%	378 33.8%	766 34.5%
49-72h	238 21.6%	219 19.6%	457 20.6%
73-96h	72 6.5%	86 7.7%	158 7.1%
97-120h	38 3.4%	36 3.2%	74 3.3%
>120h	1 0.1%	3 0.3%	4 0.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	CDB-2914	Levonorgestrel
Arm/Group Description	CDB-2914: Single dose (30 mg)	Levonorgestrel: Single dose (1.5 mg)
Measure Participants	1104	1117
Count of Participants [Participants]	20 1.8%	30 2.7%

2. Secondary Outcome

Title	Actual Pregnancy Rate Compared to Expected Pregnancy Rate
Description	Conditional probabilities of pregnancy from the time of unprotected sex intercourse to treatment were estimated for up to 120 hours using Spline Cubic Estimation (Stone & Koo, 1985) Pregnancy rate expected in the absence of emergency contraception is based on Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception. 1998;57(6):363-9.
Time Frame	Within 120 hours of unprotected Intercourse

Outcome Measure Data

Analysis Population Description

Efficacy evaluable population (women aged 35 years or younger who were enrolled for the first time in the study and whose pregnancy status after treatment was known)

Arm/Group Title	CDB-2914	Levonorgestrel
Arm/Group Description	CDB-2914: Single dose (30 mg)	Levonorgestrel: Single dose (1.5 mg)
Measure Participants	843	851
Number of pregnancies observed	15 1.4%	22 2%
Number of expected pregnancies	47 4.3%	46 4.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CDB-2914
	Comments	Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	% of observed pregnancies
	Estimated Value	1.78
	Confidence Interval	(2-Sided) 95%; 1.04 to 2.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	Expected pregnancy rate = 5.58%

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Levonorgestrel
	Comments	Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	% of observed pregnancies
	Estimated Value	2.59
	Confidence Interval	(2-Sided) 95%; 1.68 to 3.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	Expected pregnancy rate = 5.43%

3. Secondary Outcome

Title	Menstrual Bleeding Patterns
Description	Onset of next menses after emergency contraception compared to usual date.
Time Frame	within the menstrual cycle of the unprotected Intercourse

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	CDB-2914	Levonorgestrel
Arm/Group Description	CDB-2914: Single dose (30 mg)	Levonorgestrel: Single dose (1.5 mg)
Measure Participants	1104	1117
Mean (Standard Deviation) [DAYS]	2.1 (8.2)	-1.2 (7.9)

Adverse Events

Time Frame	At the most 60 days after treatment.
Arm/Group Title	CDB-2914		Levonorgestrel
Arm/Group Description	CDB-2914: Single dose (30 mg)		Levonorgestrel: Single dose (1.5 mg)
All Cause Mortality
	CDB-2914		Levonorgestrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1104 (0%)		0/1117 (0%)
Serious Adverse Events
	CDB-2914		Levonorgestrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/1104 (0.3%)		4/1117 (0.4%)
Eye disorders
Right contact lense related corneal ulcer	1/1104 (0.1%)	1	0/1117 (0%)	0
Gastrointestinal disorders
Vomiting blood stained fluid	0/1104 (0%)	0	1/1117 (0.1%)	1
General disorders
Dizziness	1/1104 (0.1%)	1	0/1117 (0%)	0
Pregnancy, puerperium and perinatal conditions
Molar pregnancy	0/1104 (0%)	0	1/1117 (0.1%)	1
Renal and urinary disorders
Urinary tract infection	1/1104 (0.1%)	1	0/1117 (0%)	0
Kidney stones	0/1104 (0%)	0	1/1117 (0.1%)	1
Reproductive system and breast disorders
ruptured ovarian cyst	0/1104 (0%)	0	1/1117 (0.1%)	1
Other (Not Including Serious) Adverse Events
	CDB-2914		Levonorgestrel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	596/1104 (54%)		572/1117 (51.2%)
Gastrointestinal disorders
Nausea	141/1104 (12.8%)	141	126/1117 (11.3%)	126
Abdominal pain	56/1104 (5.1%)	56	75/1117 (6.7%)	75
General disorders
Fatigue	61/1104 (5.5%)	61	44/1117 (3.9%)	44
Nervous system disorders
Headache	213/1104 (19.3%)	213	211/1117 (18.9%)	211
Dizziness	56/1104 (5.1%)	56	55/1117 (4.9%)	55
Reproductive system and breast disorders
Dysmenorrhoea	142/1104 (12.9%)	142	160/1117 (14.3%)	160

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.