Trial · NCT00965562
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
NCT00965562, Not applicable, Completed, Donaghue Medical Research Foundation; results first posted 2015-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS). Trials, record NCT00965562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965562
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
- NCT number
- NCT00965562
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 49 participants, actual
- Lead sponsor
- Donaghue Medical Research Foundation
- Conditions
- Premenstrual Syndrome
- Interventions
- Fluoxetine, Calcium, Placebo
- First posted
- 2009-08-25
- Last updated
- 2015-03-23
- Results first posted
- 2015-02-26
- Limitations and caveats
- small sample size
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of the Change in IDS Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline 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). 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. |
| Primary | Comparison of the Change in PMTS Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline 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). 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. |
| Primary | Comparison of the Change in CGI-S Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | 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. |
| Primary | Comparison of the Change in DRSP Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | 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. |
| Primary | Comparison of the Change in CGI Improvement Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | 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. |
| Secondary | Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | 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. |
| Secondary | Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline 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=least severe, 84=most severe). LOCF: last observation carried forward. |
| Secondary | Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline 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). LOCF: last observation carried forward. |
| Secondary | Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement) | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | 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. |
| Secondary | Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement) | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | 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). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Response analysis includes all data from all subjects with the last observation carried forward to Visit 5. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Response analysis includes all data from all subjects with the last observation carried forward to Visit 5. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Response analysis includes all data from all subjects with the last observation carried forward to Visit 5. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement) | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | 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. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement) | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement) | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. | proportion of participants | NUMBER |
| PRIMARY | Comparison of the Change in IDS Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Intention to treat cohort. | units on IDS scale | MEAN |
| PRIMARY | Comparison of the Change in PMTS Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Intention to treat cohort. | units on PMTS scale | MEAN |
| PRIMARY | Comparison of the Change in CGI-S Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Intention to treat cohort. | units on CGI-S scale | MEAN |
| PRIMARY | Comparison of the Change in DRSP Symptom Scores Among Groups | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | Intention to treat cohort. | units on DRSP scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) | I: Fluoxetine | 0.80 | proportion of participants | ||
| Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) | II: Calcium | 0.42 | proportion of participants | ||
| Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) | III: Placebo | 0.42 | proportion of participants | ||
| Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) | I: Fluoxetine | 0.77 | proportion of participants | ||
| Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) | II: Calcium | 0.31 | proportion of participants | ||
| Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) | III: Placebo | 0.31 | proportion of participants | ||
| Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) | I: Fluoxetine | 0.62 | proportion of participants | ||
| Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) | II: Calcium | 0.33 | proportion of participants | ||
| Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) | III: Placebo | 0.16 | proportion of participants | ||
| Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement) | I: Fluoxetine | 1.00 | proportion of participants |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | I: Fluoxetine | 16 | |
| Overall Study | STARTED | II: Calcium | 17 | |
| Overall Study | STARTED | III: Placebo | 16 | |
| Overall Study | Women With at Least 2 Follow up Visits | I: Fluoxetine | 13 | |
| Overall Study | Women With at Least 2 Follow up Visits | II: Calcium | 13 | |
| Overall Study | Women With at Least 2 Follow up Visits | III: Placebo | 13 | |
| Overall Study | Women Who Participated Full Follow up | I: Fluoxetine | 6 | |
| Overall Study | Women Who Participated Full Follow up | II: Calcium | 10 | |
| Overall Study | Women Who Participated Full Follow up | III: Placebo | 11 | |
| Overall Study | COMPLETED | I: Fluoxetine | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Feeling spacy | General disorders | I: Fluoxetine | 0 | 10 | 0 |
| other | Feeling spacy | General disorders | II: Calcium | 2 | 11 | 2 |
| other | Feeling spacy | General disorders | III: Placebo | 0 | 11 | 0 |
| other | Abdominal ache | Gastrointestinal disorders | I: Fluoxetine | 0 | 10 | 0 |
| other | Abdominal ache | Gastrointestinal disorders | II: Calcium | 1 | 11 | 1 |
| other | Abdominal ache | Gastrointestinal disorders | III: Placebo | 0 | 11 | 0 |
| other | Burping | Gastrointestinal disorders | I: Fluoxetine | 0 | 10 | 0 |
| other | Burping | Gastrointestinal disorders | II: Calcium | 1 | 11 | 1 |
| other | Burping | Gastrointestinal disorders | III: Placebo | 0 | 11 | 0 |
| other | Difficulty Concentrating | General disorders | I: Fluoxetine | 0 | 10 | 0 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | I: Fluoxetine | ||
| Total, all-cause mortality | II: Calcium | ||
| Total, all-cause mortality | III: Placebo | ||
| Total, other adverse events | I: Fluoxetine | 4 | 10 |
| Total, other adverse events | II: Calcium | 8 | 11 |
| Total, other adverse events | III: Placebo | 2 | 11 |
| Total, serious adverse events | I: Fluoxetine | 0 | 10 |
| Total, serious adverse events | II: Calcium | 0 | 11 |
| Total, serious adverse events | III: Placebo | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00965562
GET https://conductscience.org/api/trials/v1/NCT00965562/results?page=2