MedTrace Logo

Letrozole Treatment in Normal and GnRH Deficient Women

NCT00351416 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-07-27

Study results available
· View outcomes & findings →

Summary

This research study involves the use of the drugs Letrozole, GnRH, and NAL-GLU GnRH antagonist. Letrozole is a drug that is approved by the U.S. Food and Drug Administration (FDA) for use in breast cancer treatment that has been found to block the formation of estrogen. The NAL-GLU GnRH antagonist is a drug that temporarily blocks the action of GnRH. GnRH is a hormone that the body makes that stimulates other hormones that then control the function of the ovary.

The purpose is to study the effects of the administration of letrozole in women with GnRH deficiency at the same time that they receive gonadotropin-releasing hormone (GnRH). In addition, administration of letrozole and NAL-GLU GnRH antagonist in healthy women with normal menstrual cycles will be done to evaluate the role of estrogen in the control of the hormone FSH, or Follicle Stimulating Hormone, in the female reproductive cycle. A better understanding of FSH control may help in the development of new treatments for women with difficulty conceiving.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Letrozole

Letrozole 20 mg orally one time

DRUG

NAL-GLU GnRH antagonist

5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-21
Primary Completion
2009-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00351416 on ClinicalTrials.gov