|
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:
|
7 January 2013 |
|
Main ID: |
NCT00001454 |
|
Date of registration:
|
03/11/1999 |
|
Primary sponsor: |
|
|
Public title:
|
Hormonal Effects on the Uterus and Endometrium
|
|
Scientific title:
|
Endometrial Mediators of Gonadal Steroid Action |
|
Date of first enrolment:
|
April 1995 |
|
Target sample size:
|
203 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00001454 |
|
Study type:
|
Observational |
|
Study design:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) |
|
Address:
|
|
|
Telephone:
|
800-411-1222 |
|
Email:
|
prpl@mail.cc.nih.gov |
|
Affiliation:
|
|
|
|
Name:
|
Lynnette K Nieman, M.D. |
|
Address:
|
|
|
Telephone:
|
(301) 496-8935 |
|
Email:
|
niemanl@cc1.nichd.nih.gov |
|
Affiliation:
|
|
|
|
Name:
|
Lynnette K Nieman, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|
|
Key inclusion & exclusion criteria
|
- INCLUSION CRITERIA:
Healthy volunteers will be in excellent health.
Only women with regular menstrual cycles (every 26-35 days) using mechanical (condoms,
diaphragm) or sterilization methods of contraception will be included.
Only women with a negative pregnancy test, normal physical examination and laboratory
results, and a luteal phase progesterone value of greater than 4 ng/mL will be entered
into this study.
Women with endometriosis will be recruited from those with histologically-proven
endometriosis. Except for this diagnosis they will meet criteria for healthy volunteers
as stated above.
Women may participate in the study on more than one occasion, but biopsies may not be
performed in a "baseline" cycle.
Age minimum:
18 Years
Age maximum:
43 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Pregnancy
|
|
Secondary ID(s)
|
|
95-CH-0110
|
|
950110
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|