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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after hormone replacement therapy

Awards & highlights

Study 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

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after hormone replacement therapy

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

6,845,889 Total Patients Enrolled

29 Trials studying Obesity

9,206 Patients Enrolled for Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,356 Previous Clinical Trials

4,314,926 Total Patients Enrolled

446 Trials studying Obesity

588,798 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies is 2 typically administered to treat?

"2 is a common treatment for hormone receptor unknown, and its efficacy has been established in cases of orchidectomy, orchitis, as well as advanced prostate cancer."

Answered by AI

Is it permissible for minors to participate in this investigation?

"As specified in the eligibility criteria, only patients between 18 to 62 years old can take part in this trial. For younger and older individuals respectively, there are 214 trials and 764 trials available for them to enroll into."

Answered by AI

Who meets the eligibility criteria for this experiment?

"In order to enrol in the trial, individuals should possess obesity and be within the ages of 18-62. The research team is expecting to attract 140 participants overall."

Answered by AI

What is the maximum size of enrollees in this research study?

"This clinical trial has already reached their specified enrollment and is no longer recruiting patients. This study initially appeared on May 1st 2005, with the last edit to its page occurring on August 5th 2019. If you are searching for other medical trials involving obesity, there are 973 studies actively seeking participants while 206 more open investigations require two or more patients."

Answered by AI

Are there any other empirical investigations involving 2?

"Currently, 206 active clinical trials are investigating the efficacy of 2 with 58 such studies in Phase 3. Duarte, California is one location where a lot of research on this drug is conducted. However, there are 12370 sites around the world working to further our understanding of its potential use cases."

Answered by AI

Are recruitment opportunities still available for this clinical trial?

"According to the clinicaltrials.gov, this trial is not looking for candidates as of now; it was initially posted on May 1st 2005 and last modified on August 5th 2019. Nevertheless, 1179 other medical trials are currently seeking enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regulation of Cortisol Metabolism and Fat Patterning

Jonathan Purnell 2005. "Regulation of Cortisol Metabolism and Fat Patterning". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00694733.

All > Obesity > Menopause