Trial Outcomes & Findings for Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) (NCT NCT00965562)
NCT ID: NCT00965562
Last Updated: 2015-03-23
Results Overview
IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Results posted on
2015-03-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
16
|
|
Overall Study
Women With at Least 2 Follow up Visits
|
13
|
13
|
13
|
|
Overall Study
Women Who Participated Full Follow up
|
6
|
10
|
11
|
|
Overall Study
COMPLETED
|
13
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
Baseline Characteristics
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Baseline characteristics by cohort
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
25-29 years old
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Age, Customized
30-39 years old
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Age, Customized
40-45 years old
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not collected
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Marital Status
Married
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Marital Status
Single/Divorced/Widowed
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Marital Status
Not collected
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Number of pregnancies
0 pregnancies
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Number of pregnancies
1 pregnancy
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Number of pregnancies
2+ pregnancies
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Years with PMS
<4 years
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Years with PMS
5-10 years
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Years with PMS
>10 years
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Years with PMS
Number of years not collected
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Ever spoken to a doctor about PMS
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
OB-GYN asked about PMS
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Thought about getting help for PMS
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Concurrent oral contraceptive use
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Baseline Symptom Scores
Inventory of Depressive Symptomatology (IDS-C30)
|
31.85 units on a scale
STANDARD_DEVIATION 9.14 • n=5 Participants
|
30.92 units on a scale
STANDARD_DEVIATION 7.62 • n=7 Participants
|
28.85 units on a scale
STANDARD_DEVIATION 9.97 • n=5 Participants
|
30.54 units on a scale
STANDARD_DEVIATION 5.17 • n=4 Participants
|
|
Baseline Symptom Scores
Premenstrual Tension Syndrome-Observer (PMTS-O)
|
24.15 units on a scale
STANDARD_DEVIATION 5.40 • n=5 Participants
|
21.58 units on a scale
STANDARD_DEVIATION 3.73 • n=7 Participants
|
20.85 units on a scale
STANDARD_DEVIATION 6.62 • n=5 Participants
|
22.19 units on a scale
STANDARD_DEVIATION 3.11 • n=4 Participants
|
|
Baseline Symptom Scores
Daily Record of Severity of Problems (DRSP)
|
2.16 units on a scale
STANDARD_DEVIATION 0.86 • n=5 Participants
|
1.12 units on a scale
STANDARD_DEVIATION 0.38 • n=7 Participants
|
1.29 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
1.52 units on a scale
STANDARD_DEVIATION 0.37 • n=4 Participants
|
|
Baseline Symptom Scores
Clinical Global Impression - Severity (CGI-S)
|
4.92 units on a scale
STANDARD_DEVIATION 0.95 • n=5 Participants
|
4.46 units on a scale
STANDARD_DEVIATION 1.27 • n=7 Participants
|
4.15 units on a scale
STANDARD_DEVIATION 1.28 • n=5 Participants
|
4.51 units on a scale
STANDARD_DEVIATION 0.68 • n=4 Participants
|
PRIMARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Intention to treat cohort.
IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Comparison of the Change in IDS Symptom Scores Among Groups
Visit 5
|
10.00 units on IDS scale
Standard Deviation 6.41
|
19.55 units on IDS scale
Standard Deviation 9.04
|
18.08 units on IDS scale
Standard Deviation 9.17
|
|
Comparison of the Change in IDS Symptom Scores Among Groups
Visit 1
|
31.85 units on IDS scale
Standard Deviation 9.14
|
30.92 units on IDS scale
Standard Deviation 7.62
|
28.85 units on IDS scale
Standard Deviation 9.97
|
|
Comparison of the Change in IDS Symptom Scores Among Groups
Visit 2
|
14.08 units on IDS scale
Standard Deviation 9.53
|
25.77 units on IDS scale
Standard Deviation 7.74
|
20.69 units on IDS scale
Standard Deviation 12.20
|
|
Comparison of the Change in IDS Symptom Scores Among Groups
Visit 3
|
11.44 units on IDS scale
Standard Deviation 7.94
|
18.55 units on IDS scale
Standard Deviation 10.40
|
20.15 units on IDS scale
Standard Deviation 14.25
|
|
Comparison of the Change in IDS Symptom Scores Among Groups
Visit 4
|
11.78 units on IDS scale
Standard Deviation 8.50
|
18.50 units on IDS scale
Standard Deviation 9.01
|
16.46 units on IDS scale
Standard Deviation 11.00
|
PRIMARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Intention to treat cohort.
PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Comparison of the Change in PMTS Symptom Scores Among Groups
Visit 1
|
24.15 units on PMTS scale
Standard Deviation 5.40
|
21.58 units on PMTS scale
Standard Deviation 3.73
|
20.85 units on PMTS scale
Standard Deviation 6.62
|
|
Comparison of the Change in PMTS Symptom Scores Among Groups
Visit 2
|
11.15 units on PMTS scale
Standard Deviation 5.77
|
18.54 units on PMTS scale
Standard Deviation 5.36
|
16.00 units on PMTS scale
Standard Deviation 8.15
|
|
Comparison of the Change in PMTS Symptom Scores Among Groups
Visit 3
|
10.33 units on PMTS scale
Standard Deviation 6.40
|
13.36 units on PMTS scale
Standard Deviation 5.75
|
16.38 units on PMTS scale
Standard Deviation 10.52
|
|
Comparison of the Change in PMTS Symptom Scores Among Groups
Visit 4
|
12.11 units on PMTS scale
Standard Deviation 7.13
|
12.83 units on PMTS scale
Standard Deviation 4.73
|
12.77 units on PMTS scale
Standard Deviation 8.21
|
|
Comparison of the Change in PMTS Symptom Scores Among Groups
Visit 5
|
10.13 units on PMTS scale
Standard Deviation 3.56
|
11.91 units on PMTS scale
Standard Deviation 4.48
|
14.58 units on PMTS scale
Standard Deviation 7.58
|
PRIMARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Intention to treat cohort.
CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Comparison of the Change in CGI-S Symptom Scores Among Groups
Visit 1
|
4.92 units on CGI-S scale
Standard Deviation 0.95
|
4.46 units on CGI-S scale
Standard Deviation 1.27
|
4.15 units on CGI-S scale
Standard Deviation 1.28
|
|
Comparison of the Change in CGI-S Symptom Scores Among Groups
Visit 2
|
2.54 units on CGI-S scale
Standard Deviation 1.13
|
4.23 units on CGI-S scale
Standard Deviation 1.01
|
3.38 units on CGI-S scale
Standard Deviation 1.66
|
|
Comparison of the Change in CGI-S Symptom Scores Among Groups
Visit 3
|
2.33 units on CGI-S scale
Standard Deviation 1.00
|
3.00 units on CGI-S scale
Standard Deviation 1.10
|
3.38 units on CGI-S scale
Standard Deviation 1.98
|
|
Comparison of the Change in CGI-S Symptom Scores Among Groups
Visit 4
|
2.56 units on CGI-S scale
Standard Deviation 1.13
|
2.73 units on CGI-S scale
Standard Deviation 0.90
|
2.92 units on CGI-S scale
Standard Deviation 1.50
|
|
Comparison of the Change in CGI-S Symptom Scores Among Groups
Visit 5
|
2.50 units on CGI-S scale
Standard Deviation 0.76
|
2.91 units on CGI-S scale
Standard Deviation 1.04
|
3.17 units on CGI-S scale
Standard Deviation 1.47
|
PRIMARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Intention to treat cohort.
DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Comparison of the Change in DRSP Symptom Scores Among Groups
Visit 4
|
0.72 units on DRSP scale
Standard Deviation 0.78
|
0.51 units on DRSP scale
Standard Deviation 0.33
|
0.59 units on DRSP scale
Standard Deviation 0.63
|
|
Comparison of the Change in DRSP Symptom Scores Among Groups
Visit 1
|
2.16 units on DRSP scale
Standard Deviation 0.86
|
1.12 units on DRSP scale
Standard Deviation 0.38
|
1.29 units on DRSP scale
Standard Deviation 0.60
|
|
Comparison of the Change in DRSP Symptom Scores Among Groups
Visit 2
|
0.97 units on DRSP scale
Standard Deviation 0.72
|
0.76 units on DRSP scale
Standard Deviation 0.78
|
0.93 units on DRSP scale
Standard Deviation 0.54
|
|
Comparison of the Change in DRSP Symptom Scores Among Groups
Visit 3
|
0.27 units on DRSP scale
Standard Deviation 0.78
|
0.61 units on DRSP scale
Standard Deviation 0.78
|
1.19 units on DRSP scale
Standard Deviation 1.06
|
|
Comparison of the Change in DRSP Symptom Scores Among Groups
Visit 5
|
0.44 units on DRSP scale
Standard Deviation 0.34
|
0.75 units on DRSP scale
Standard Deviation 0.42
|
0.74 units on DRSP scale
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Intention to treat cohort.
CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Comparison of the Change in CGI Improvement Scores Among Groups
Visit 5
|
1.88 units on CGI Improvement scale
Standard Deviation 0.64
|
2.45 units on CGI Improvement scale
Standard Deviation 0.82
|
2.83 units on CGI Improvement scale
Standard Deviation 1.19
|
|
Comparison of the Change in CGI Improvement Scores Among Groups
Visit 1
|
NA units on CGI Improvement scale
Standard Deviation NA
at first visit, improvement since last visit cannot be scored
|
NA units on CGI Improvement scale
Standard Deviation NA
at first visit, improvement since last visit cannot be scored
|
NA units on CGI Improvement scale
Standard Deviation NA
at first visit, improvement since last visit cannot be scored
|
|
Comparison of the Change in CGI Improvement Scores Among Groups
Visit 2
|
2.23 units on CGI Improvement scale
Standard Deviation 0.83
|
3.46 units on CGI Improvement scale
Standard Deviation 0.78
|
3.00 units on CGI Improvement scale
Standard Deviation 1.35
|
|
Comparison of the Change in CGI Improvement Scores Among Groups
Visit 3
|
1.67 units on CGI Improvement scale
Standard Deviation 0.87
|
2.30 units on CGI Improvement scale
Standard Deviation 0.82
|
3.08 units on CGI Improvement scale
Standard Deviation 1.50
|
|
Comparison of the Change in CGI Improvement Scores Among Groups
Visit 4
|
1.75 units on CGI Improvement scale
Standard Deviation 1.16
|
2.36 units on CGI Improvement scale
Standard Deviation 1.03
|
2.77 units on CGI Improvement scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.
DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.
Outcome measures
| Measure |
I: Fluoxetine
n=10 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=12 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=12 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)
|
0.80 proportion of participants
|
0.42 proportion of participants
|
0.42 proportion of participants
|
SECONDARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.
IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=13 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)
|
0.77 proportion of participants
|
0.31 proportion of participants
|
0.31 proportion of participants
|
SECONDARY outcome
Timeframe: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visitPopulation: Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.
PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.
Outcome measures
| Measure |
I: Fluoxetine
n=13 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=12 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=13 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)
|
0.62 proportion of participants
|
0.33 proportion of participants
|
0.16 proportion of participants
|
SECONDARY outcome
Timeframe: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visitPopulation: For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. However, Visit 5 DRSP calendars were missing for an additional 3 subjects in the fluoxetine group and for one subject in each of the calcium and placebo cells.
Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.
Outcome measures
| Measure |
I: Fluoxetine
n=5 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=8 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=6 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)
|
1.00 proportion of participants
|
0.50 proportion of participants
|
0.33 proportion of participants
|
SECONDARY outcome
Timeframe: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visitPopulation: For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.
Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe).
Outcome measures
| Measure |
I: Fluoxetine
n=8 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=11 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=12 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)
|
1.00 proportion of participants
|
0.36 proportion of participants
|
0.33 proportion of participants
|
SECONDARY outcome
Timeframe: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visitPopulation: For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.
Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).
Outcome measures
| Measure |
I: Fluoxetine
n=8 Participants
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=11 Participants
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=12 Participants
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)
|
0.75 proportion of participants
|
0.36 proportion of participants
|
0.17 proportion of participants
|
Adverse Events
I: Fluoxetine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
II: Calcium
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
III: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
I: Fluoxetine
n=10 participants at risk
Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
|
II: Calcium
n=11 participants at risk
Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
|
III: Placebo
n=11 participants at risk
Placebo : For 4 cycles, women will receive placebo.
|
|---|---|---|---|
|
General disorders
Feeling spacy
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
18.2%
2/11 • Number of events 2 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Gastrointestinal disorders
Abdominal ache
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Gastrointestinal disorders
Burping
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Difficulty Concentrating
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Reproductive system and breast disorders
Cramps
|
10.0%
1/10 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Reproductive system and breast disorders
Decreased sex drive
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
18.2%
2/11 • Number of events 2 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Dry mouth
|
20.0%
2/10 • Number of events 2 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Fatigue
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
27.3%
3/11 • Number of events 3 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
18.2%
2/11 • Number of events 2 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Irritability
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
36.4%
4/11 • Number of events 4 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
18.2%
2/11 • Number of events 2 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Sweating
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
|
General disorders
Vertigo
|
0.00%
0/10 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
9.1%
1/11 • Number of events 1 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
0.00%
0/11 • From patient randomization to completion of study
Final adverse event data were only available for the 32 patients randomized at the Yale site. There were no severe adverse events by self-report. Events were uncommon and occurred in all 3 groups with a numerically higher number in the calcium group.
|
Additional Information
Dr. Kimberly Yonkers
Donaghue Medical Research Foundation
Phone: 1-203-764-6621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place