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Trial record 61 of 403 for:    LEVONORGESTREL

A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication

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: NCT00482963
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : July 15, 2013
Sponsor:
Collaborators:
The Miriam Hospital
University of Washington
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE June 5, 2007
First Posted Date  ICMJE June 6, 2007
Last Update Posted Date July 15, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz [ Time Frame: 12 hour pharmacokinetic study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00482963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
  • Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz [ Time Frame: 12 hour pharmacokinetic study ]
  • Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz [ Time Frame: 3 weeks ]
  • Changes in liver function tests before and during efavirenz [ Time Frame: 3 weeks ]
  • The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls [ Time Frame: 12 hour pharmacokinetic study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
Official Title  ICMJE A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
Brief Summary The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.
Detailed Description The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Contraception
  • Pharmacokinetics
Intervention  ICMJE Drug: levonorgestrel, efavirenz
Study Arms  ICMJE Experimental: levonorgestrel, efavirenz
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
Intervention: Drug: levonorgestrel, efavirenz
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2007)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, HIV-1 seronegative women of child-bearing age.

Exclusion Criteria:

  • Current use of hormonal contraception
  • Pregnancy/Breast Feeding
  • Post-menopausal status
  • Obesity
  • Hepatitis B or C
  • Psychiatric illness
  • Active Substance Abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482963
Other Study ID Numbers  ICMJE 06-1178
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • The Miriam Hospital
  • University of Washington
  • Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Monica L Carten, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP