A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: NCCTG study N04CA.

Abstract

Purpose-Vaginal dryness is a common problem, for which effective and safe non-estrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted.Methods-A double-blind, placebo-controlled, randomized trial design was used to compare pilocarpine, at target doses of 5 mg twice daily and 5 mg four times daily, to a placebo. Vaginal dryness was recorded by patient-completed questionnaires at baseline and weekly for 6 weeks after study initiation. The primary endpoint for this study was the area under the curve (AUC) summary statistic comprised of the longitudinal responses obtained at baseline and through the six weeks of treatment to a numerical analogue scale asking patients to rate their perceived amount of vaginal dryness. The primary analysis was carried out by a single t-test using a two-sided Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Results-A total of 201 patients enrolled in this trial. The primary analysis, comparing vaginal dryness symptoms in the collective pilocarpine arms against the placebo arm, did not reveal any benefit for the pilocarpine treatment. This finding was confirmed by other secondary analyses. Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared to the placebo arm. NIH Public AccessConclusion-Pilocarpine did not alleviate vaginal dryness.

Efficacy of Hormonal and Nonhormonal Approaches to Vaginal Atrophy and Sexual Dysfunctions in Postmenopausal Women: A Systematic Review

“…A total of 55 studies were deemed eligible for inclusion ( Table 1, Supplementary material ). The approaches tested to treat vaginal atrophy and sexual dysfunction were as follows: lubricants and moisturizers (18 studies, 14 15 16 17 18 19 20 21 22 23 24 25 26 5 27 28 29 30 31 of which evaluated hyaluronic acid); phytoestrogens (14 studies); 30 32 33 34 35 36 37 38 39 40 41 42 43 44 dehydroepiandrosterone (DHEA; 8 studies); 27 45 46 47 48 49 50 51 ospemifene (5 studies); 52 53 54 55 56 vaginal testosterone (4 studies); 16 19 57 58 pelvic floor muscle exercises (2 studies); 59 60 oxytocin (2 studies); 61 62 vaginal CO 2 laser (2 studies); 63 64 lidocaine (1 study); 65 and vitamin E vaginal suppository (1 study). 66…”

“…Regarding side effects, the results for lubricants and moisturizers indicated that all adverse events (AEs) were considered mild in severity and self-limited. 14 15 16 17 18 19 20 21 22 23 24 25 26 The most common AEs were burn on the application site, discomfort on the application site, vulvovaginal pruritus, and general pruritus. The compound hyaluronic acid has been shown to be well tolerated without side effects among most patients tested.…”