|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00455962 |
|
Date of registration:
|
02/04/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Race on Gonadotropin Responses
|
|
Scientific title:
|
Effect of Race on Gonadotropin Responses to Short Term Negative and Positive Feedback Effects of Gonadal Steroids |
|
Date of first enrolment:
|
January 2005 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00455962 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Janet E Hall, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Premenopausal Women
- Will be non-smokers or smoke less than 10 cigarettes/day
- African-American women aged 18 to 35 years and Caucasian women aged 18 to 45 years
- 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
- With no evidence of androgen excess.
- Subjects must have no known sensitivity to any medications used in the relevant
protocol and be willing to use abstinence or barrier methods of contraception for the
duration of the study.
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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Premenopause
|
|
Intervention(s)
|
|
Drug: Estradiol steroid infusion
|
|
Drug: Progesterone steroid infusion
|
|
Primary Outcome(s)
|
|
LH response to estrogen positive feedback
[Time Frame: 5 days of estradiol and progesterone infusion]
|
|
Secondary ID(s)
|
|
2003P-001397
|
|
Sundry Department Fund
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|