Status:
UNKNOWN
Letrozole Treatment in Normal and GnRH Deficient Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
Brief 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 ca...
Detailed Description
The negative feedback control of FSH is crucial for the precise regulation of follicular development in the female. An important component of this feedback is exerted by estrogen. Letrozole will be us...
Eligibility Criteria
Inclusion
- 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
- History of liver and/or kidney disease
- Substance or alcohol abuse
- Hormone dependent neoplasia including breast cancer
- Women who are trying to become pregnant
Key Trial Info
Start Date :
January 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00351416
Start Date
January 21 2004
Last Update
July 27 2017
Active Locations (1)
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1
Reproductive Endocrine Unit, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114