Trial · NCT00343382

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

NCT00343382, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2014-09-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer. Trials, record NCT00343382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00343382

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
NCT number: NCT00343382
Status: Completed
Phases: Phase 3
Enrollment: 201 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Breast Cancer, Vaginal Dryness
Interventions: pilocarpine hydrochloride, placebo
First posted: 2006-06-23
Last updated: 2016-08-12
Results first posted: 2014-09-30

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics	Baseline to Week 6	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.
Secondary	Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	End of 6 weeks	CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
Secondary	Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living	Baseline to Week 6	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.
Secondary	Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores	Baseline and Week 6	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics	Baseline to Week 6	Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).	units on a scale	MEAN
SECONDARY	Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	End of 6 weeks		participants	NUMBER
SECONDARY	Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living	Baseline to Week 6	Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores	Baseline and Week 6	Includes all participants who completed both baseline and week 6 assessments.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group51

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics	Collective Placebo		63.6	Standard Deviation 24.04	units on a scale
Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics	Pilocarpine 2 Times Per Day		55.8	Standard Deviation 27.69	units on a scale
Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics	Pilocarpine 4 Times Per Day		66.0	Standard Deviation 21.38	units on a scale
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Collective Placebo	Grade 1 or 2 rigors	2		participants
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Pilocarpine 2 Times Per Day	Grade 1 or 2 rigors	14		participants
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Pilocarpine 4 Times Per Day	Grade 1 or 2 rigors	17		participants
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Collective Placebo	Grade 1 or 2 urinary frequency	12		participants
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Pilocarpine 2 Times Per Day	Grade 1 or 2 urinary frequency	21		participants
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Pilocarpine 4 Times Per Day	Grade 1 or 2 urinary frequency	29		participants
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0	Collective Placebo	Grade 1 or 2 nausea	7		participants

1 to 10 of 51Source ClinicalTrials.gov

See all 51 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Collective Placebo	64
Overall Study	STARTED	Pilocarpine 2 Times Per Day	65
Overall Study	STARTED	Pilocarpine 4 Times Per Day	66
Overall Study	COMPLETED	Collective Placebo	60
Overall Study	COMPLETED	Pilocarpine 2 Times Per Day	51
Overall Study	COMPLETED	Pilocarpine 4 Times Per Day	49
Overall Study	NOT COMPLETED	Collective Placebo	4
Overall Study	NOT COMPLETED	Pilocarpine 2 Times Per Day	14
Overall Study	NOT COMPLETED	Pilocarpine 4 Times Per Day	17

Source ClinicalTrials.gov

Adverse events54

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	Flashing vision	Eye disorders	Pilocarpine 2 Times Per Day	1	65	1
other	Flashing vision	Eye disorders	Pilocarpine 4 Times Per Day	0	66	0
other	Flashing vision	Eye disorders	Collective Placebo	0	63	0
other	Abdominal distension	Gastrointestinal disorders	Pilocarpine 2 Times Per Day	1	65	1
other	Abdominal distension	Gastrointestinal disorders	Pilocarpine 4 Times Per Day	0	66	0
other	Abdominal distension	Gastrointestinal disorders	Collective Placebo	0	63	0
other	Diarrhea	Gastrointestinal disorders	Pilocarpine 2 Times Per Day	0	65	0
other	Diarrhea	Gastrointestinal disorders	Pilocarpine 4 Times Per Day	1	66	1
other	Diarrhea	Gastrointestinal disorders	Collective Placebo	0	63	0
other	Dry mouth	Gastrointestinal disorders	Pilocarpine 2 Times Per Day	0	65	0

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pilocarpine 2 Times Per Day
Total, all-cause mortality	Pilocarpine 4 Times Per Day
Total, all-cause mortality	Collective Placebo
Total, other adverse events	Pilocarpine 2 Times Per Day	48	65
Total, other adverse events	Pilocarpine 4 Times Per Day	47	66
Total, other adverse events	Collective Placebo	33	63
Total, serious adverse events	Pilocarpine 2 Times Per Day	0	65
Total, serious adverse events	Pilocarpine 4 Times Per Day	0	66
Total, serious adverse events	Collective Placebo	0	63

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21702402	RESULT

Source PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00343382

GET https://conductscience.org/api/trials/v1/NCT00343382/results?page=2

API reference For AI assistants