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Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women Clinical research trials and Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women. Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women clinical trial. Human subjects frequently get the finest healthcare available for their Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women  Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
For Condition: HIV Infections,Cachexia
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Charles R. Drew University of Medicine and Science
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
ShalenderBhasin, Study Chair, Charles R. Drew University of Medicine and Science
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting K. Yarashaski 314-362-9700
Los Angeles County Harbor-UCLA Medical Center *Recruiting*
Torrance, California, 90509
United States
Recruiting G. Beall 310-222-2444
Charles R. Drew University of Medicine and Science *Recruiting*
Los Angeles, California, 90059
United States
Recruiting Shalender Bhasin 213-563-9353
Additional Information:
Study ID Numbers: 199/13251; CDUMS-FDR001397
Study Start Date: April 1997
Record last reviewed: May 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004400
Other Cachexia Studies:
1. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
2. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
3. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
4. Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer
5. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
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Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
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