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Perimenopausal Estrogen Replacement Therapy Study (PERT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308814
First Posted: March 4, 2011
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Girdler, PhD, University of North Carolina, Chapel Hill
Results First Submitted: April 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Perimenopause
Menopause
Depression
Interventions: Drug: Estradiol
Drug: Placebo

  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
Placebo

Placebo patches for 12 months and placebo pills for 12 days every 2 months.

Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.

Estradiol

Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.

Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered.


Participant Flow:   Overall Study
    Placebo   Estradiol
STARTED   86   86 
COMPLETED   69   63 
NOT COMPLETED   17   23 



  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.
Perimenopausal women.

Reporting Groups
  Description
Placebo

Placebo patches for 12 months and placebo pills for 12 days every 2 months.

Placebo: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.

Estradiol

Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.

Estradiol: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered.

Total Total of all reporting groups

Baseline Measures
   Placebo   Estradiol   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   86   172 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      86 100.0%      86 100.0%      172 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.5  (3.0)   50.5  (3.0)   50.5  (3.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      86 100.0%      86 100.0%      172 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   86   86   172 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Depressive Symptoms as Indicated by The Center for Epidemiologic Studies Depression Scale (CES-D)   [ Time Frame: Baseline, month 12 ]

2.  Primary:   Change in Psychiatric Diagnosis as Assessed by the Structured Clinical Interview for DSM Disorders I/NP   [ Time Frame: Baseline and when prompted by CES-D score ]

3.  Primary:   Change in Stress Reactivity During Laboratory Session Including Trier Social Stress Test   [ Time Frame: Baseline, month 12 ]

4.  Secondary:   Change in Functional Well-being as Assessed by the Medical Outcomes Study 36-item Short Form (SF-36)   [ Time Frame: Baseline, month 12 ]

5.  Secondary:   Percentage Meeting Criteria for Metabolic Risk [Baseline and Month 12]   [ Time Frame: Baseline, month 12 ]

6.  Secondary:   Change in Percentage of Brachial Artery Diameter   [ Time Frame: Baseline, month 12 ]

7.  Secondary:   Change in Baroreceptor Sensitivity   [ Time Frame: Baseline, month 12 ]


  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: Susan S. Girdler, Ph.D.
Organization: University of North Carolina at Chapel Hill
phone: 919-966-2179
e-mail: susan_girdler@med.unc.edu



Responsible Party: Susan Girdler, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01308814     History of Changes
Other Study ID Numbers: 10-0542
R01MH087619 ( U.S. NIH Grant/Contract )
First Submitted: February 28, 2011
First Posted: March 4, 2011
Results First Submitted: April 6, 2017
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017