CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 15 enrolled
Drug / intervention
Letrozole +1 moredrug
Likely dose
Letrozole 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00351416
NCT00351416Phase 2Unknown

Letrozole Treatment in Normal and GnRH Deficient Women

Massachusetts General Hospital·interventional·Posted Jul 12, 2006·Updated Jul 27, 2017

In Brief

A Phase 2 clinical trial evaluating Letrozole and NAL-GLU GnRH antagonist for Healthy Volunteers. Targeting 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2UnknownOverdue
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2006
Enrollment StartJan 21, 2004
Primary CompletionJun 29, 2009
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 20.0 years ago

Interventions

Letrozoledrug

Letrozole 20 mg orally one time

NAL-GLU GnRH antagonistdrug

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