Feasibility Study for Development of an Early Test for Ovarian Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lawrence Nelson, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006156
First received: August 9, 2000
Last updated: March 28, 2013
Last verified: March 2013
Results First Received: March 28, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Healthy
Premature Ovarian Failure
Interventions: Other: Control
Drug: Drug: FSH

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Drug - FSH No text entered.
Control No text entered.

Participant Flow:   Overall Study
    Drug - FSH     Control  
STARTED     42     7  
COMPLETED     42     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Drug - FSH No text entered.
Control No text entered.
Total Total of all reporting groups

Baseline Measures
    Drug - FSH     Control     Total  
Number of Participants  
[units: participants]
  42     7     49  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     41     7     48  
>=65 years     1     0     1  
Gender  
[units: Participants]
     
Female     42     7     49  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     1     3     4  
Not Hispanic or Latino     40     4     44  
Unknown or Not Reported     1     0     1  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     7     0     7  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     1     6  
White     29     3     32  
More than one race     0     0     0  
Unknown or Not Reported     1     3     4  



  Outcome Measures
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1.  Primary:   Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.   [ Time Frame: 24 hours ]

2.  Secondary:   Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Nelson, Lawrence Merle
Organization: National Institute of Child Health and Human Development
phone: +1 301 402 6608
e-mail: nelsonl@mail.nih.gov


Publications:

Responsible Party: Lawrence Nelson, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006156     History of Changes
Other Study ID Numbers: 000189, 00-CH-0189
Study First Received: August 9, 2000
Results First Received: March 28, 2013
Last Updated: March 28, 2013
Health Authority: United States: Federal Government