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The Effects of Aging and Estrogen on the Pituitary

NCT00386022 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-04-13

Study results available
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Summary

The purpose of this study is to study the effects of aging and estrogen on the brain. Specifically, this study will examine how the hypothalamus signals the pituitary gland to secrete reproductive hormones and how that changes with aging.

Conditions

  • Healthy

Interventions

DRUG

GnRH

GnRH doses of 25, 75, 250 and 750 ng/kg will be given IV every 4 hr at baseline and after transdermal estradiol

DRUG

NAL-GLU GnRH antagonist

A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg before and after transdermal estradiol

DRUG

Estrogen patch

transdermal estrogen patches 0.05mg/day, changing the patch every 86 hr in second part of sequential study

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Janet E Hall, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2012-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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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 NCT00386022 on ClinicalTrials.gov