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| Sponsor: | Oregon Health and Science University |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00694733 |
Purpose
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 |
|---|---|
|
Obesity Menopause |
Drug: Placebo injection Drug: Depo Lupron/Aromatase inhibitor Drug: Depo Lupron/placebo Drug: placebo Drug: Estrogen cream |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Regulation of Cortisol Metabolism and Fat Patterning |
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Men on placebo injections for 4 months
|
Drug: Placebo injection
Normal saline injection IM monthly for 4 months
Other Name: Normal Saline
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Active Comparator: 2
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.
Other Names:
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Active Comparator: 3
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.
Other Names:
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Placebo Comparator: 4
Women on placebo cream
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Drug: placebo
Placebo Cream 1ml applied twice daily for four months
Other Name: Placebo cream
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Active Comparator: 5
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.
Other Name: Estradiol cream
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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).
Eligibility| 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:
Contacts and Locations| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Jonathan Q. Purnell, M.D. | OHSU - Center for the Study of Weight Regulation |
More Information
| Responsible Party: | Jonanthan Q. Purnell, OHSU - Center for the Study of Weight Regulation |
| ClinicalTrials.gov Identifier: | NCT00694733 History of Changes |
| Other Study ID Numbers: | eIRB #937, OCTRI #862 |
| Study First Received: | June 6, 2008 |
| Last Updated: | July 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Menopause Cortisol |
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Testosterone Estradiol Estrogens Cortisol succinate Hydrocortisone acetate Hydrocortisone Leuprolide Aromatase Inhibitors |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Fertility Agents Reproductive Control Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |