NCT00343382

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer. PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works compared to a placebo in treating vaginal dryness in patients with breast cancer.

Detailed description

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs \> 65), concurrent tamoxifen therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), concurrent aromatase inhibitor therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), and perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe). Patients are randomized to 1 of 4 treatment arms. The primary and secondary objectives of the study are described below. OBJECTIVES: Primary * Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal dryness in patients with breast cancer. Secondary * Evaluate any toxicities arising from pilocarpine hydrochloride in these patients. * Evaluate quality of life of these patients treated with pilocarpine hydrochloride. Quality of life was assessed at baseline and then weekly for 6 weeks.

Conditions

• Breast Cancer
• Vaginal Dryness

Interventions

Type	Name	Description
DRUG	pilocarpine hydrochloride	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-07-01
• Completion: 2012-12-01
• First posted: 2006-06-23
• Last updated: 2016-08-12
• Results posted: 2014-09-30

Locations

192 sites across 1 country: United States