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Trial record 1 of 1 for:    NCT00551616
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Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00551616
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
HRA Pharma

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: 1 Drug: CDB-2914
Single dose

Active Comparator: 2 Drug: Levonorgestrel
Single dose




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: Within 72 hours of unprotected Intercourse ]

Secondary Outcome Measures :
  1. Prevented fraction (number of prevented pregnancies divided by number of expected pregnancies) [ Time Frame: Within 120 hours of unprotected Intercourse ]
  2. Menstrual bleeding patterns [ Time Frame: within the menstrual cycle of the unprotected Intercourse ]
  3. Frequencies of subjects with treatment emergent adverse events [ Time Frame: Within 120 hours of unprotected Intercourse ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 IUD 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551616


Locations
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Sponsors and Collaborators
HRA Pharma
Investigators
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Principal Investigator: Anna F Glasier, MD NHS Lothian Family Planning Service
Publications of Results:
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Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT00551616    
Other Study ID Numbers: 2914-004
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral