NCT00351416

Letrozole Treatment in Normal and GnRH Deficient Women

Status unknown Phase 1, PHASE2 Results posted Last updated 27 July 2017

What this trial tests

Phase 1, PHASE2 trial testing Letrozole in Healthy Volunteers in 15 participants. Status unknown.

Timeline

21 January 2004

Primary endpoint
29 June 2009

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	15
Start date	21 January 2004
Primary completion	29 June 2009
Sites	1 location across United States

Drugs / interventions tested

• Letrozole — full drug profile →
• NAL-GLU GnRH antagonist — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 40, female only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

FSH Level Primary · EFP: average of menstrual cycle day 6 in the EFP; LFP: average of 2 days after follicle size of 16 mm

Difference in FSH peak following letrozole administration compared with control cycle

Group	Value	95% CI
Aromatase Inhibitor EFP	7.25	± 2.42
Aromatase Inhibitor LFP	8.71	± 1.58

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.