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Effect of Race on Gonadotropin Responses

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Janet E. Hall, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455962
First received: April 2, 2007
Last updated: March 16, 2017
Last verified: March 2017
Results First Received: March 16, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Other
Conditions: Premenopause
Healthy
Interventions: Drug: Estradiol steroid infusion
Drug: Progesterone steroid infusion

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
African American Women

Healthy African-American women 18-35 years old

Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr

Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr

Caucasian Women

Healthy Caucasian women 18-35 years old

Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr

Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr


Participant Flow:   Overall Study
    African American Women   Caucasian Women
STARTED   15   15 
COMPLETED   10   13 
NOT COMPLETED   5   2 
Lost to Follow-up                5                2 



  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.
No text entered.

Reporting Groups
  Description
African American Women

Healthy African-American women 18-35 years old

Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr

Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr

Caucasian Women

Healthy Caucasian women 18-35 years old

Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr

Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr

Total Total of all reporting groups

Baseline Measures
   African American Women   Caucasian Women   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   13   23 
Age 
[Units: Years]
Mean (Full Range)
 28 
 (22 to 36) 
 28 
 (23 to 36) 
 28 
 (22 to 36) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10 100.0%      13 100.0%      23 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      10 100.0%      13 100.0%      23 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      10 100.0%      0   0.0%      10  43.5% 
White      0   0.0%      13 100.0%      13  56.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   13   23 


  Outcome Measures

1.  Primary:   LH Peak in Response to Estrogen Positive Feedback   [ Time Frame: 5 days of estradiol and progesterone infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Janet E. Hall, MD
Organization: Massachusetts General Hospital
phone: 617-877-1112
e-mail: jehall@partners.org


Publications of Results:

Responsible Party: Janet E. Hall, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455962     History of Changes
Other Study ID Numbers: 2003P-001397
Sundry Department Fund ( Other Identifier: MGH-REU Department Fund )
R01AG013241 ( US NIH Grant/Contract Award Number )
Study First Received: April 2, 2007
Results First Received: March 16, 2017
Last Updated: March 16, 2017