Letrozole Treatment in Normal and GnRH Deficient Women

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institutes of Health (NIH)
• Treatments: Aromatase Inhibitors; Letrozole; LHRH, N-Ac-2-Nal(1)-4-Cl-Phe(2)-3-Pal(3)-Arg(5)-Glu(6)-AlaNH2(10)-; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

Healthy Normal Subjects will meet the following criteria:

• 18 to 35 years of age

• good general health

• on no medications including any hormonal drug products for at least 3 months before the study

• regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone > 3 ng/ml

• no evidence of androgen excess

• normal TSH, prolactin and hemoglobin

• use of double-barrier contraception, permanent sterilization or abstinence during the cycle of study.

• Negative pregnancy test (serum) at the beginning of each cycle of study

• Normal Liver Function Test

Exclusion Criteria:

• History of liver and/or kidney disease

• Substance or alcohol abuse

• Hormone dependent neoplasia including breast cancer

• Women who are trying to become pregnant