Text Size

MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Research on Women's Health (ORWH)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00894543
First received: May 5, 2009
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
Results First Received: February 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hot Flashes
Menopause
Vasomotor Symptoms
Interventions: Drug: Escitalopram
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from July 2009 to June 2010. The trial was conducted at four MsFLASH network sites: University of Pennsylvania, Massachusetts General Hospital, Indiana University, Kaiser Permanente Division of Research in Oakland, California

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following enrollment (signing the consent), symptoms and health were reviewed, brief physical exam conducted and urine pregnancy test administered, daily hot flash diaries completed for one week (in addition to two weeks before enrollment).

Reporting Groups
  Description
Escitalopram Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
Placebo Inactive pill

Participant Flow for 3 periods

 Period 1:   Baseline
    Escitalopram     Placebo  
STARTED     104     101  
COMPLETED     104     101  
NOT COMPLETED     0     0  

Period 2:   Baseline to Week 4
    Escitalopram     Placebo  
STARTED     104     101  
COMPLETED     101     99  
NOT COMPLETED     3     2  
No diary or lost or withdrew                 3                 2  

Period 3:   Week 4 to Week 8
    Escitalopram     Placebo  
STARTED     101     99  
COMPLETED     97     97  
NOT COMPLETED     4     2  
No diary or lost or withdrew                 4                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Escitalopram Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
Placebo Inactive pill
Total Total of all reporting groups

Baseline Measures
    Escitalopram     Placebo     Total  
Number of Participants  
[units: participants]
 		  104     101     205  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     104     101     205  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  53.45  ± 4.20     54.36  ± 3.86     53.9  ± 4.0  
Gender  
[units: participants]
 		     
Female     104     101     205  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     47     48     95  
White     53     49     102  
More than one race     0     0     0  
Unknown or Not Reported     4     4     8  
Region of Enrollment  
[units: participants]
 		     
United States     104     101     205  
Menopausal Status  
[units: participants]
 		     
Postmenopause     84     83     167  
Late transition     17     15     32  
Early transition     3     3     6  
Body Mass Index (BMI) [1]
[units: participants]
 		     
<25, kg/m^2     32     22     54  
25-<30, kg/m^2     34     38     72  
>=30, kg/m^2     38     40     78  
Missing data     0     1     1  
Hysterectomy  
[units: participants]
 		     
Hysterectomy     13     13     26  
Hysterectomy and oophorectomy     11     8     19  
Oophorectomy only     3     1     4  
None     77     78     155  
Don't know     0     1     1  
[1] BMI calculated as (body weight in kilograms) divided by (body height in meters squared) (kg/m^2)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Primary:   Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries   [ Time Frame: week 4 minus baseline ]
  Show Outcome Measure 2

3.  Primary:   Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries   [ Time Frame: week 8 minus baseline ]
  Show Outcome Measure 3

4.  Primary:   Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries   [ Time Frame: Baseline ]
  Show Outcome Measure 4

5.  Primary:   Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries   [ Time Frame: week 4 minus baseline ]
  Hide Outcome Measure 5

Measure Type Primary
Measure Title Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
Measure Description

Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.

Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).
Time Frame week 4 minus baseline  
Safety Issue No  

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.
Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).

Reporting Groups
  Description
Escitalopram Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
Placebo Inactive pill

Measured Values
    Escitalopram     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  100     97  
Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries  
[units: Scores on a scale]
Mean ( 95% Confidence Interval ) 		  -0.43  
  ( -0.54 to -0.33 )   		  -0.23  
  ( -0.34 to -0.13 )  

No statistical analysis provided for Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries



6.  Primary:   Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries   [ Time Frame: week 8 minus baseline ]
  Show Outcome Measure 6

7.  Secondary:   Daily Hot Flash Bother, Recorded on Daily Diaries   [ Time Frame: Baseline ]
  Show Outcome Measure 7

8.  Secondary:   Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries   [ Time Frame: week 4 minus baseline ]
  Show Outcome Measure 8

9.  Secondary:   Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries   [ Time Frame: week 8 minus baseline ]
  Show Outcome Measure 9


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
Although this was a community-based sample, the volunteers may be a select group motivated to seek treatment. An 8-week trial is brief, but data indicate that this interval is sufficient to determine long-term efficacy of a nonhormonal compound.  


Results Point of Contact:  
Name/Title: Dr. Ellen W. Freeman
Organization: University of Pennsylvania School of Medicine
phone: 215-349-5521
e-mail: freemane@mail.med.upenn.edu


Publications of Results:


Responsible Party: Andrea LaCroix, Garnet Anderson, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00894543     History of Changes
Other Study ID Numbers: MsFLASH-01, 1 U01 AG032699-01, 1 U01 AG032656-01
Study First Received: May 5, 2009
Results First Received: February 17, 2011
Last Updated: March 5, 2013
Health Authority: United States: Federal Government