MedTrace Logo

Regulation of Cortisol Metabolism and Fat Patterning

NCT00694733 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-12-16

No results posted yet for this study

Summary

The purpose of this study is to determine if estrogen or testosterone can affect cortisol levels and where fat builds up in our bodies.

Conditions

Interventions

DRUG

Placebo injection

Normal saline injection IM monthly for 4 months

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.

DRUG

Depo Lupron/placebo

Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.

DRUG

placebo

Placebo Cream 1ml applied twice daily for four months

DRUG

Estrogen cream

Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.

Sponsors & Collaborators

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

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jonathan Q. Purnell, M.D. · OHSU - Center for the Study of Weight Regulation

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2024-03-31
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694733 on ClinicalTrials.gov