TriangleNCT00343382 · STUDY IN CONTEXT
Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.
The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- qol key
- qol-0000
- source section id
- NCT00343382-om-0000
- source outcome index
- 0
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
- measure definition
- Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- time frame
- Baseline to Week 6
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- qol key
- qol-0002
- source section id
- NCT00343382-om-0002
- source outcome index
- 2
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living
- measure definition
- The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- time frame
- Baseline to Week 6
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- qol key
- qol-0003
- source section id
- NCT00343382-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores
- measure definition
- The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.
- time frame
- Baseline and Week 6
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Includes all participants who completed both baseline and week 6 assessments.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- trial label
- Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 3
- qol Count
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0000
- source section id
- NCT00343382-om-0000
- source outcome index
- 0
- endpoint
- Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
- endpoint definition
- Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- time origin
- Baseline to Week 6
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0001
- source section id
- NCT00343382-om-0001
- source outcome index
- 1
- endpoint
- Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0
- endpoint definition
- CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
- time origin
- End of 6 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0002
- source section id
- NCT00343382-om-0002
- source outcome index
- 2
- endpoint
- Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living
- endpoint definition
- The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- time origin
- Baseline to Week 6
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0003
- source section id
- NCT00343382-om-0003
- source outcome index
- 3
- endpoint
- Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores
- endpoint definition
- The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.
- time origin
- Baseline and Week 6
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Includes all participants who completed both baseline and week 6 assessments.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Collective Placebo
- regimen
- Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Pilocarpine 2 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Pilocarpine 4 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Collective Placebo
- regimen
- Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Pilocarpine 2 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Pilocarpine 4 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
- analyzed count
- 66
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Collective Placebo
- regimen
- Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
- analyzed count
- 62
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Pilocarpine 2 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
- analyzed count
- 61
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Pilocarpine 4 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Collective Placebo
- regimen
- Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Pilocarpine 2 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Pilocarpine 4 Times Per Day
- regimen
- Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00343382-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- harm key
- EG000
- source section id
- NCT00343382-ae
- event group key
- EG000
- event group label
- Pilocarpine 2 Times Per Day
- serious affected
- 0
- serious at risk
- 65
- other affected
- 48
- other at risk
- 65
- frequency threshold
- 0
- collection period
- End of 6 Weeks
- event definition
- Adverse event information at end of 6 weeks is not available on one participant from collective placebo arm.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- harm key
- EG001
- source section id
- NCT00343382-ae
- event group key
- EG001
- event group label
- Pilocarpine 4 Times Per Day
- serious affected
- 0
- serious at risk
- 66
- other affected
- 47
- other at risk
- 66
- frequency threshold
- 0
- collection period
- End of 6 Weeks
- event definition
- Adverse event information at end of 6 weeks is not available on one participant from collective placebo arm.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- harm key
- EG002
- source section id
- NCT00343382-ae
- event group key
- EG002
- event group label
- Collective Placebo
- serious affected
- 0
- serious at risk
- 63
- other affected
- 33
- other at risk
- 63
- frequency threshold
- 0
- collection period
- End of 6 Weeks
- event definition
- Adverse event information at end of 6 weeks is not available on one participant from collective placebo arm.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- qol key
- qol-0000
- source section id
- NCT00343382-om-0000
- source outcome index
- 0
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
- measure definition
- Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- time frame
- Baseline to Week 6
- analysis role
- primary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- qol key
- qol-0002
- source section id
- NCT00343382-om-0002
- source outcome index
- 2
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living
- measure definition
- The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- time frame
- Baseline to Week 6
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00343382
- qol key
- qol-0003
- source section id
- NCT00343382-om-0003
- source outcome index
- 3
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores
- measure definition
- The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.
- time frame
- Baseline and Week 6
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Includes all participants who completed both baseline and week 6 assessments.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice