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

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. Identifier: NCT00004400
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Cachexia Drug: testosterone Phase 2

Detailed Description:

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.

Completion date provided represents the completion date of the grant per OOPD records

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 1997
Study Completion Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


--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

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 identifier (NCT number): NCT00004400

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United States, California
Charles R. Drew University of Medicine and Science
Los Angeles, California, United States, 90059
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, United States, 90509
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Charles Drew University of Medicine and Science
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Study Chair: Shalender Bhasin Charles Drew University of Medicine and Science
Layout table for additonal information Identifier: NCT00004400    
Other Study ID Numbers: 199/13251
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: May 1998
Keywords provided by FDA Office of Orphan Products Development:
disease-related problem/condition
human immunodeficiency virus infection
immunologic disorders and infectious disorders
quality of life
rare disease
viral infection
Additional relevant MeSH terms:
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Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs