At a glance
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Letrozole Treatment in Normal and GnRH Deficient Women
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
Timeline
Interventions
Letrozole 20 mg orally one time
5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously