Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 1998 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Charles Drew University of Medicine and Science
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004400
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: May 1998

October 18, 1999
June 23, 2005
April 1997
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Complete list of historical versions of study NCT00004400 on ClinicalTrials.gov Archive Site
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Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
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OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free mass, therefore contributing to weight maintenance, improved muscle function, and quality of life in HIV-infected women.

II. Examine the mechanism of testosterone-induced increase in fat-free mass.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of three arms.

Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4 days).

Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week (every 3-4 days).

Arm III: Patients receive two testosterone transdermal patches applied twice a week (every 3-4 days).

Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end of the recovery period. Quality of life is assessed before treatment begins and at weeks 6 and 12.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Cachexia
Drug: testosterone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
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PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically confirmed premenopausal HIV-positive women who have experienced 5-15% weight loss

--Prior/Concurrent Therapy--

  • Endocrine therapy: At least 3 months since megestrol At least 3 months since anabolic or androgenic steroids At least 3 months since oral contraceptives At least 3 months since Depo-Provera No concurrent hormone replacement therapy
  • Other: Concurrent retroviral or protease inhibitors allowed, dosage must be stable At least 3 months since ketoconazole At least 6 weeks since the initiation of protease inhibitors

--Patient Characteristics--

  • Hepatic: No significant liver disease SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Bilirubin no greater than 2 mg/dL No medical complications due to alcohol abuse
  • Renal: Not specified
  • Cardiovascular: No significant cardiovascular disease No uncontrolled hypertension
  • Other: Testosterone level (early morning) less than 30 ng/dL Normal gastrointestinal function as indicated by: Absence of diarrhea Normal D-xylose absorption test No acute opportunistic infections or infectious illness No malignant disease No history of breast cancer No history of endometrial cancer No fever of known or unknown origin No unremitting diarrhea defined as: At least 4 watery stools per day OR More than 4 watery stools recently OR Acute change in stool habit with fever No significant respiratory disease No diabetes No illicit drugs within the past 6 months No history of hyperandrogenic disorders such as: Hirsutism Polycystic ovary disease Not pregnant or lactating
Female
18 Years to 50 Years
No
United States
 
NCT00004400
199/13251, CDUMS-FDR001397
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FDA Office of Orphan Products Development
Charles Drew University of Medicine and Science
Study Chair: Shalender Bhasin Charles Drew University of Medicine and Science
FDA Office of Orphan Products Development
May 1998

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