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Sponsors and Collaborators: |
Oregon Health and Science University National Institutes of Health (NIH) |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00694733 |
The purpose of this study is to determine if estrogen or testosterone can affect cortisol levels and where fat builds up in our bodies.
Condition | Intervention |
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Obesity Menopause |
Drug: Placebo injection Drug: Depo Lupron/Aromatase inhibitor Drug: Depo Lupron/placebo Drug: placebo Drug: Estrogen cream |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Regulation of Cortisol Metabolism and Fat Patterning |
Estimated Enrollment: | 150 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Men on placebo injections for 4 months
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Drug: Placebo injection
Normal saline injection IM monthly for 4 months
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2: Active Comparator
Men who receive Depo Lupron for 4 months, then are replaced with testosterone and aromatase inhibitor for 4 months.
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Drug: Depo Lupron/Aromatase inhibitor
Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8.
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3: Active Comparator
Men who receive Depo Lupron for 4 months, then are replaced with testosterone and placebo for 4 months.
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Drug: Depo Lupron/placebo
Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.
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4: Placebo Comparator
Women on placebo cream
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Drug: placebo
Placebo Cream 1ml applied twice daily for four months
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5: Active Comparator
Women on estrogen cream
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Drug: Estrogen cream
Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.
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Subjects will be studied 3 or 4 times on the inpatient unit of the Oregon Clinical and Translational Research Center. During each visit, testing will include measuring the amount of whole body fat and fat in the stomach area, muscle, and liver; levels of cortisol in the blood, urine, and fat tissue (taken from a biopsy); how well insulin works (insulin sensitivity).
Ages Eligible for Study: | 18 Years to 62 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded for potential confounders on body weight, cortisol production rates, sex steroid metabolism, or contraindications to strong magnetic fields:
Contact: Jonathan Q. Purnell, M.D. | 503-494-1056 | purnellj@ohsu.edu |
Contact: Bethany Klopfenstein, M.D. | 503-494-4020 | klopfens@ohsu.edu |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Jonathan Q. Purnell, M.D. 503-494-1056 purnellj@ohsu.edu | |
Contact: Bethany Klopfenstein, M.D. 503-494-4020 klopfens@ohsu.edu | |
Principal Investigator: Jonanthan Q Purnell, M.D. |
Principal Investigator: | Jonathan Q. Purnell, M.D. | OHSU - Center for the Study of Weight Regulation |
Responsible Party: | OHSU - Center for the Study of Weight Regulation ( Jonanthan Q. Purnell ) |
Study ID Numbers: | eIRB #937, OCTRI #862 |
Study First Received: | June 6, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00694733 |
Health Authority: | United States: Institutional Review Board |
Obesity Menopause Cortisol |
Obesity Anastrozole Hydrocortisone Cortisol succinate Estradiol valerate Benzocaine Overweight Estradiol 17 beta-cypionate Methyltestosterone Estradiol Testosterone 17 beta-cypionate |
Body Weight Signs and Symptoms Testosterone Leuprolide Estradiol 3-benzoate Nutrition Disorders Overnutrition Hydrocortisone acetate Polyestradiol phosphate Menopause |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Therapeutic Uses |
Physiological Effects of Drugs Fertility Agents Reproductive Control Agents Pharmacologic Actions |