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Hormone Therapy

Hormone Therapy for Obesity

N/A
Waitlist Available
Led By Jonathan Q. Purnell, M.D.
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
40 postmenopausal women (age 40-62) and 30 men (age 18-45) who are healthy, at their lifetime maximal weight, have been weight stable for at least six months prior to entry, have a BMI between 19 and 39.9 kg/m2, and are willing to commit to not making significant changes to their diet or daily activities while enrolled in the study.
Be between 18 and 65 years old
Must not have
Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders)
Any subject with previously unevaluated postmenopausal bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after hormone replacement therapy
Awards & highlights

Summary

This trialinvestigates if hormones affect how fat is stored in the body and how stress hormones are affected.

Who is the study for?
This trial is for postmenopausal women aged 40-62 and men aged 18-45 who are healthy, at their heaviest lifetime weight, stable in weight for the past six months, with a BMI of 19 to 39.9. Participants must not plan diet or activity changes during the study. Exclusions include those with certain diseases, metal implants, endocrine disorders, abnormal bleeding or prostate issues; also excluded are heavy drinkers, smokers, frequent exercisers and those on blood thinners.Check my eligibility
What is being tested?
The study tests if estrogen cream or testosterone (via Depo Lupron/Aromatase inhibitor) affects cortisol levels and fat distribution compared to placebos (placebo injection/cream). It's designed to see how these hormones might influence body composition after menopause in women and in younger men.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally hormone treatments like estrogen can cause mood swings, skin irritation where applied; testosterone may affect mood and increase acne risk. Placebos typically have no active ingredients but can lead to perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy postmenopausal woman aged 40-62 or a man aged 18-45, at my heaviest weight, with a stable weight and BMI between 19 and 39.9, and I can maintain my current diet and activity levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a psychiatric illness or am taking medication for one.
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I have had bleeding after menopause that hasn't been checked.
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I am on blood thinners or have had an abnormal exam result.
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I have an untreated hormone disorder affecting my body's fat and muscle.
Select...
I cannot use estrogen due to health reasons.
Select...
I have had a prostate exam in the last year.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after hormone replacement therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after hormone replacement therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure 24-hour CPR, free cortisol, and cortisol binding globulin levels in plasma; HSD 1 activity, glucocorticoid receptor binding, and cortisol levels in adipocytes; and urinary excretion of cortisol, cortisone and their metabolites.
Secondary outcome measures
To measure intramyocellular fat and intrahepatic fat by MRS, visceral and subcutaneous abdominal fat by CT scan, body composition (fat mass, lean mass, and bone mass) by DXA, and insulin sensitivity.

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: 2Active Control1 Intervention
Men who receive Depo Lupron for 4 months, then are replaced with testosterone and aromatase inhibitor for 4 months.
Group II: 3Active Control1 Intervention
Men who receive Depo Lupron for 4 months, then are replaced with testosterone and placebo for 4 months.
Group III: 5Active Control1 Intervention
Women on estrogen cream
Group IV: 1Placebo Group1 Intervention
Men on placebo injections for 4 months
Group V: 4Placebo Group1 Intervention
Women on placebo cream

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
985 Previous Clinical Trials
7,385,584 Total Patients Enrolled
29 Trials studying Obesity
9,206 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,314,962 Total Patients Enrolled
453 Trials studying Obesity
588,825 Patients Enrolled for Obesity
Jonathan Q. Purnell, M.D.Principal InvestigatorOHSU - Center for the Study of Weight Regulation
4 Previous Clinical Trials
123 Total Patients Enrolled
4 Trials studying Obesity
123 Patients Enrolled for Obesity

Media Library

Depo Lupron/Aromatase inhibitor (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00694733 — N/A
Obesity Research Study Groups: 1, 2, 3, 4, 5
Obesity Clinical Trial 2023: Depo Lupron/Aromatase inhibitor Highlights & Side Effects. Trial Name: NCT00694733 — N/A
Depo Lupron/Aromatase inhibitor (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00694733 — N/A
~7 spots leftby Jul 2025