Status:
COMPLETED
Effect of Race on Gonadotropin Responses
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Premenopause
Healthy
Eligibility:
FEMALE
18-35 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to attempt to determine why estrogen levels are increased in African-American women as compared to Caucasian women by evaluating estrogen feedback on the brain. African-Am...
Detailed Description
Several independent lines of evidence have suggested that reproductive endocrine dynamics may differ between African-American (AAW) and Caucasian (CW) women. There is an increased incidence of dizygot...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- African-American women aged 18 to 35 years and Caucasian women aged 18 to 36 years. Subjects will be asked to volunteer information on ethnicity (self classification). Only African-American and Caucasian subjects will be included in this aim to address the specific hypotheses.
- BMI \<30
- In good general health with normal TSH, prolactin and hemoglobin
- Normal BUN and Creatinine (\< 2 times the upper limit of normal)
- On no medications for \> 2 months before the study
- Regular menstrual cycles every 25 to 35 days and ovulation documented by a luteal phase progesterone \> 3 ng/ml
- Willing to use abstinence or barrier methods of contraception for the duration of the study.
- Exclusion criteria:
- postmenopausal
- smoking \>9 cigarettes per day
- evidence of androgen excess.
- sensitivity to any medications used in the relevant protocol
- race other than African-American or Caucasian
- Hispanic ethnicity
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00455962
Start Date
January 1 2005
End Date
December 1 2011
Last Update
July 27 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114