ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

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.
ClinicalTrials.gov Identifier: NCT01126801
Recruitment Status : Terminated (Stopped enrolling subjects due to challenge of identifying eligible participants)
First Posted : May 20, 2010
Results First Posted : August 22, 2016
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Menopausal Depression
Interventions Drug: Estradiol
Other: Placebo control
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description Estradiol: Oral estradiol 1.0 mg/day for four weeks. Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Estradiol Placebo Total
Hide Arm/Group Description Estradiol: Oral estradiol 1.0 mg/day for four weeks. Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month. Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
50  (0) 55  (0) 52.5  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.
Hide Description [Not Specified]
Time Frame one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description:
Estradiol: Oral estradiol 1.0 mg/day for four weeks.
Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.
Hide Description [Not Specified]
Time Frame one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description:
Estradiol: Oral estradiol 1.0 mg/day for four weeks.
Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description Estradiol: Oral estradiol 1.0 mg/day for four weeks. Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
All-Cause Mortality
Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Due to the challenge of identifying eligible participants, we decided to stop enrolling subjects and not to analyze the 2 completed participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Hadine Joffe
Organization: Brigham & Women's Hospital
Phone: 617-732-4906
Responsible Party: Hadine Joffe, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01126801     History of Changes
Other Study ID Numbers: 2009p001776
First Submitted: May 11, 2010
First Posted: May 20, 2010
Results First Submitted: July 12, 2016
Results First Posted: August 22, 2016
Last Update Posted: October 20, 2017