Trial record 1 of 1 for:    Hormones and Cognitive Processing in Early Postmenopausal Women
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Early Menopause Hormone Treatment and Cognition (R21)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yolanda Smith, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01046643
First received: January 11, 2010
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: February 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Menopausal Syndrome
Interventions: Drug: Estradiol (E2)
Drug: Progesterone (P10) x90
Drug: Progesterone (P10) x10

  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
+++__Women were recruited from 3/1/2010 to 7/29/2011 through local newspaper ads, flyers, electronic newsletters, bulletin boards, clinics and the Women’s Health Registry, a University of Michigan database of women interested in participating in women’s health related clinical research.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Several enrolled participants were excluded from the trial prior to assignment in groups on the basis of the risk factors identified at the pre-screening appointment. Some others did not qualify due to their lab results which did not meet the inclusion criteria.

Reporting Groups
  Description
Estrogen Followed by Placebo

Estrogen treatment with Estradiol (E2)

One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day

Progesterone Followed by Placebo

Progesterone (P10) treatment

One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day.

Placebo Followed by Estrogen One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days.
Placebo Followed by Progesterone One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.

Participant Flow for 3 periods

Period 1:   First Period Treatment or Placebo
    Estrogen Followed by Placebo     Progesterone Followed by Placebo     Placebo Followed by Estrogen     Placebo Followed by Progesterone  
STARTED     9     7     7     7  
COMPLETED     9     6     7     7  
NOT COMPLETED     0     1     0     0  
Withdrawal by Subject                 0                 1                 0                 0  

Period 2:   Washout Period
    Estrogen Followed by Placebo     Progesterone Followed by Placebo     Placebo Followed by Estrogen     Placebo Followed by Progesterone  
STARTED     9     6     7     7  
COMPLETED     9     6     7     7  
NOT COMPLETED     0     0     0     0  

Period 3:   Second Period Treatment or Placebo
    Estrogen Followed by Placebo     Progesterone Followed by Placebo     Placebo Followed by Estrogen     Placebo Followed by Progesterone  
STARTED     9     6     7     7  
COMPLETED     9     6     7     7  
NOT COMPLETED     0     0     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.
No text entered.

Reporting Groups
  Description
Estrogen and Placebo

Estrogen treatment with Estradiol (E2)

Participants received both an Estradiol capsule (E2) (1mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day).

Progesterone and Placebo

Progesterone treatment (P10)

Participants received both a Progesterone capsule (P10) (200 mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day).

Total Total of all reporting groups

Baseline Measures
    Estrogen and Placebo     Progesterone and Placebo     Total  
Number of Participants  
[units: participants]
  16     14     30  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 2.2     51.2  ± 2.9     51.5  ± 2.5  
Gender  
[units: participants]
     
Female     9     7     16  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     9     7     16  
Months since Last Menstrual Period  
[units: months]
Mean ± Standard Deviation
  19.81  ± 9.57     16.69  ± 9.80     18.41  ± 9.63  
Education  
[units: years]
Mean ± Standard Deviation
  15.75  ± 2.82     17.19  ± 2.67     16.4  ± 2.8  
Estradiol  
[units: pg/mL]
Mean ± Standard Deviation
  17.75  ± 6.30     14.38  ± 6.25     16.24  ± 6.40  
Follicle-Stimulating Hormone  
[units: mIU/mL]
Mean ± Standard Deviation
  92.34  ± 33.85     80.86  ± 21.60     87.19  ± 29.11  
BMI  
[units: kg/m²]
Mean ± Standard Deviation
  27.13  ± 6.13     28.38  ± 3.8     27.69  ± 5.17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans   [ Time Frame: August 2010 - March 2012 ]

2.  Primary:   Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans   [ Time Frame: August 2010 - March 2012 ]

3.  Secondary:   Neuropsychological Testing Scores - Verbal Learning Retention   [ Time Frame: August 2010 - March 2012 ]

4.  Secondary:   Neuropsychological Testing Scores - Visual Learning Retention   [ Time Frame: August 2010 - March 2012 ]


  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
No text entered.


  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: Dr. Yolanda Smith
Organization: The University of Michigan
phone: (734) 936-7401
e-mail: ysmith@med.umich.edu


No publications provided


Responsible Party: Yolanda Smith, M.D., University of Michigan
ClinicalTrials.gov Identifier: NCT01046643     History of Changes
Other Study ID Numbers: 1R21AG031951 - 01A1, 1R21AG031951-01A1
Study First Received: January 11, 2010
Results First Received: February 2, 2013
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board