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Trial record 11 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife 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: NCT00894543
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : March 23, 2011
Last Update Posted : March 8, 2013
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Integrative Health (NCCIH)
Office of Research on Women's Health (ORWH)
Information provided by:
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hot Flashes
Menopause
Vasomotor Symptoms
Interventions Drug: Escitalopram
Other: Placebo
Enrollment 205
Recruitment Details 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 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).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description 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. Inactive pill
Period Title: Baseline
Started 104 101
Completed 104 101
Not Completed 0 0
Period Title: Baseline to Week 4
Started 104 101
Completed 101 99
Not Completed 3 2
Reason Not Completed
No diary or lost or withdrew             3             2
Period Title: Week 4 to Week 8
Started 101 99
Completed 97 97
Not Completed 4 2
Reason Not Completed
No diary or lost or withdrew             4             2
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description 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. Inactive pill Total of all reporting groups
Overall Number of Baseline Participants 104 101 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
104
 100.0%
101
 100.0%
205
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 101 participants 205 participants
53.45  (4.20) 54.36  (3.86) 53.9  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 participants
Female
104
 100.0%
101
 100.0%
205
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 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
47
  45.2%
48
  47.5%
95
  46.3%
White
53
  51.0%
49
  48.5%
102
  49.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.8%
4
   4.0%
8
   3.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants 101 participants 205 participants
104 101 205
Menopausal Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 participants
Postmenopause 84 83 167
Late transition 17 15 32
Early transition 3 3 6
Body Mass Index (BMI)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 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
[1]
Measure Description: BMI calculated as (body weight in kilograms) divided by (body height in meters squared) (kg/m^2)
Hysterectomy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 101 participants 205 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.Primary Outcome
Title Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries
Hide Description Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 104 101
Mean (95% Confidence Interval)
Unit of Measure: Hot flashes/day
9.88
(8.67 to 11.10)
9.66
(8.70 to 10.63)
2.Primary Outcome
Title Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
Hide Description Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.
Time Frame week 4 minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 101 99
Mean (95% Confidence Interval)
Unit of Measure: Hot flashes/day
-4.37
(-5.24 to -3.50)
-2.49
(-3.31 to -1.66)
3.Primary Outcome
Title Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
Hide Description Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.
Time Frame week 8 minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 97 97
Mean (95% Confidence Interval)
Unit of Measure: Hot flashes/day
-4.60
(-5.47 to -3.74)
-3.20
(-4.15 to -2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).
Method Regression, Linear
Comments Natural log transformations applied to hot flash frequencies for modeling assumptions.
4.Primary Outcome
Title Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries
Hide Description

Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.

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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 104 101
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
2.16
(2.07 to 2.24)
2.19
(2.10 to 2.28)
5.Primary Outcome
Title Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 100 97
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.43
(-0.54 to -0.33)
-0.23
(-0.34 to -0.13)
6.Primary Outcome
Title Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
Hide Description Change in daily hot flash severity between baseline & week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. 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 8 minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 96 96
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.53
(-0.64 to -0.40)
-0.30
(-0.42 to -0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).
Method Regression, Linear
Comments Natural log transformations applied to hot flash frequencies for modeling assumptions.
7.Secondary Outcome
Title Daily Hot Flash Bother, Recorded on Daily Diaries
Hide Description

Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.

Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 104 101
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
3.12
(3.03 to 3.22)
3.16
(3.06 to 3.26)
8.Secondary Outcome
Title Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries
Hide Description

Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.

Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).

Time Frame week 4 minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 100 97
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.59
(-0.73 to -0.45)
-0.29
(-0.41 to -0.16)
9.Secondary Outcome
Title Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries
Hide Description Change in daily hot flash bother between baseline & week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).
Time Frame week 8 minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).

Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment.

Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Inactive pill
Overall Number of Participants Analyzed 96 96
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
-0.63
(-0.78 to -0.49)
-0.39
(-0.55 to -0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame Adverse events were collected during the 8 week treatment period.
Adverse Event Reporting Description Participants were assessed at baseline for symptoms using a a self-administered questionnaire listing 12 common selective serotonin reuptake inhibitor (SSRI) adverse events. Newly emergent adverse events were collected at each study visit (week 4, week 8) using a self-administered questionnaire listing 12 common SSRI adverse events.
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description 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. Inactive pill
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/101 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/104 (51.92%)      62/101 (61.39%)    
General disorders     
Fatigue, tiredness   14/104 (13.46%)  14 14/101 (13.86%)  14
Difficulty sleeping/insomnia   9/104 (8.65%)  9 10/101 (9.90%)  10
Drowsiness   14/104 (13.46%)  14 13/101 (12.87%)  13
Increased sweating   7/104 (6.73%)  7 9/101 (8.91%)  9
Dry mouth   11/104 (10.58%)  11 12/101 (11.88%)  12
Stomach or intestinal problems   10/104 (9.62%)  10 18/101 (17.82%)  18
Nausea or vomiting   11/104 (10.58%)  11 5/101 (4.95%)  5
Decreased sexual desire/ability   7/104 (6.73%)  7 8/101 (7.92%)  8
Headache   8/104 (7.69%)  8 11/101 (10.89%)  11
Vivid dreams   8/104 (7.69%)  8 9/101 (8.91%)  9
Appetite changes   6/104 (5.77%)  6 4/101 (3.96%)  4
Other symptoms   4/104 (3.85%)  4 10/101 (9.90%)  10
Dizziness/lightheadedness   3/104 (2.88%)  3 7/101 (6.93%)  7
Indicates events were collected by systematic assessment
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.
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. Ellen W. Freeman
Organization: University of Pennsylvania School of Medicine
Phone: 215-349-5521
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
1U01AG032699-01 ( U.S. NIH Grant/Contract )
1U01AG032656-01 ( U.S. NIH Grant/Contract )
First Submitted: May 5, 2009
First Posted: May 7, 2009
Results First Submitted: February 17, 2011
Results First Posted: March 23, 2011
Last Update Posted: March 8, 2013