Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT00965562
First received: August 24, 2009
Last updated: March 3, 2015
Last verified: February 2015
Results First Received: July 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Premenstrual Syndrome
Interventions: Drug: Fluoxetine
Drug: Calcium
Drug: 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
Recruitment occurred through on-site screening in private gynecological practices and community advertisements. Recruitment occurred between 2001-2005 in Providence, Rhode Island and between 2001-2009 in New Haven, Connecticut. Potential subjects provided consent for screening and assessment.

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
I: Fluoxetine Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
II: Calcium Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
III: Placebo Placebo : For 4 cycles, women will receive placebo.

Participant Flow:   Overall Study
    I: Fluoxetine     II: Calcium     III: Placebo  
STARTED     16     17     16  
Women With at Least 2 Follow up Visits     13 [1]   13 [2]   13 [3]
Women Who Participated Full Follow up     6 [4]   10 [5]   11 [6]
COMPLETED     13 [7]   13 [7]   13 [7]
NOT COMPLETED     3     4     3  
Lost to Follow-up                 1                 2                 3  
Withdrawal by Subject                 2                 2                 0  
[1] 3 patients with no follow up visits: 1 out of contact, 2 patient requests
[2] 4 patients with no follow up visits: 2 out of contact, 2 patient requests
[3] 3 patients with no follow up visits: 3 out of contact
[4] 7 patients discontinued intervention: 2 out of contact, 4 patient requests, 1 suspended by IRB
[5] 3 patients discontinued intervention: 1 out of contact, 2 patient requests
[6] 2 patients discontinued intervention: 2 patient requests
[7] Participants who completed at least 2 visits were analyzed.



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Participants with at least 2 follow up visits were included in analysis.

Reporting Groups
  Description
I: Fluoxetine Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
II: Calcium Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
III: Placebo Placebo : For 4 cycles, women will receive placebo.
Total Total of all reporting groups

Baseline Measures
    I: Fluoxetine     II: Calcium     III: Placebo     Total  
Number of Participants  
[units: participants]
  13     13     13     39  
Age, Customized  
[units: participants]
       
25-29 years old     1     1     2     4  
30-39 years old     11     6     7     24  
40-45 years old     1     6     4     11  
Gender  
[units: participants]
       
Female     13     13     13     39  
Male     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
       
White     8     10     10     28  
Black     1     0     0     1  
Hispanic     1     0     1     2  
Other/Mixed     2     1     1     4  
Not collected     1     2     1     4  
Region of Enrollment  
[units: participants]
       
United States     13     13     13     39  
Marital Status  
[units: participants]
       
Married     7     8     9     24  
Single/Divorced/Widowed     5     5     4     14  
Not collected     1     0     0     1  
Number of pregnancies  
[units: participants]
       
0 pregnancies     6     3     5     14  
1 pregnancy     3     1     0     4  
2+ pregnancies     4     9     8     21  
Years with PMS [1]
[units: participants]
       
<4 years     6     2     6     14  
5-10 years     3     6     1     10  
>10 years     3     5     6     14  
Number of years not collected     1     0     0     1  
Ever spoken to a doctor about PMS [2]
[units: participants]
  4     5     6     15  
OB-GYN asked about PMS [3]
[units: participants]
  2     5     2     9  
Thought about getting help for PMS [4]
[units: participants]
  7     7     6     20  
Concurrent oral contraceptive use [5]
[units: participants]
  4     3     3     10  
Baseline Symptom Scores [6]
[units: units on a scale]
Mean (Standard Deviation)
       
Inventory of Depressive Symptomatology (IDS-C30)     31.85  (9.14)     30.92  (7.62)     28.85  (9.97)     30.54  (5.17)  
Premenstrual Tension Syndrome-Observer (PMTS-O)     24.15  (5.40)     21.58  (3.73)     20.85  (6.62)     22.19  (3.11)  
Daily Record of Severity of Problems (DRSP)     2.16  (0.86)     1.12  (0.38)     1.29  (0.60)     1.52  (0.37)  
Clinical Global Impression - Severity (CGI-S)     4.92  (0.95)     4.46  (1.27)     4.15  (1.28)     4.51  (0.68)  
[1] PMS= premenstrual syndrome.
[2] PMS= premenstrual syndrome. Only participants who indicated that they had spoken to a doctor about their PMS were included in this affirmative measure.
[3] PMS= premenstrual syndrome. Only participants who indicated that their OB-GYN had asked about PMS were included in this affirmative measure.
[4] PMS= premenstrual syndrome. Only participants who indicated that they had thought about getting help for their PMS symptoms were included in this affirmative measure.
[5] Only participants who indicated that they were concurrently taking contraceptives were included in this affirmative measure.
[6] IDS= sum of responses to 28 of 30 possible items each scored 0 to 3 points (0=least severe 84= most severe); PMTS= total score 10 items, each with 4 points (0 is no symptom and 40 total = most severe); CGI-S= illness severity (1=normal 7=among most critically ill) . The IDS, PMTS, and CGI-S were scored on the basis of severity during the prior premenstrual phase. DRSP= 21 items each with scale (1=no symptom 6=extreme); The DRSP score was generated by subtracting average follicular phase severity from average luteal phase severity, and averaging these phase change means across symptoms.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of the Change in IDS Symptom Scores Among Groups   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

2.  Primary:   Comparison of the Change in PMTS Symptom Scores Among Groups   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

3.  Primary:   Comparison of the Change in CGI-S Symptom Scores Among Groups   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

4.  Primary:   Comparison of the Change in DRSP Symptom Scores Among Groups   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

5.  Primary:   Comparison of the Change in CGI Improvement Scores Among Groups   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

6.  Secondary:   Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

7.  Secondary:   Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

8.  Secondary:   Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)   [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]

9.  Secondary:   Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)   [ Time Frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit ]

10.  Secondary:   Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)   [ Time Frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit ]

11.  Secondary:   Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)   [ Time Frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
small sample size


  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.


Results Point of Contact:  
Name/Title: Dr. Kimberly Yonkers
Organization: Donaghue Medical Research Foundation
phone: 1-203-764-6621
e-mail: Kimberly.Yonkers@yale.edu


No publications provided


Responsible Party: Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier: NCT00965562     History of Changes
Obsolete Identifiers: NCT00683605
Other Study ID Numbers: 0001011511
Study First Received: August 24, 2009
Results First Received: July 2, 2013
Last Updated: March 3, 2015
Health Authority: United States: Federal Government