TY - JOUR
T1 - A Phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness
T2 - North central cancer treatment group study N04CA
AU - Loprinzi, Charles L.
AU - Balcueva, Ernie P.
AU - Liu, Heshan
AU - Sloan, Jeff A.
AU - Kottschade, Lisa A.
AU - Stella, Philip J.
AU - Carlson, Mark D.
AU - Moore, Dennis F.
AU - Zon, Robin T.
AU - Levitt, Ralph
AU - Jaslowski, Anthony J.
PY - 2011/5
Y1 - 2011/5
N2 - Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted. 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, with 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 summary statistic composed of the longitudinal responses obtained at baseline and through the 6 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-side alternative to compare the collective pilocarpine treatment arms with the collective placebo arms. 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 with the placebo arm.
AB - Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted. 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, with 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 summary statistic composed of the longitudinal responses obtained at baseline and through the 6 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-side alternative to compare the collective pilocarpine treatment arms with the collective placebo arms. 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 with the placebo arm.
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U2 - 10.1016/j.suponc.2011.02.005
DO - 10.1016/j.suponc.2011.02.005
M3 - Article
C2 - 21702402
AN - SCOPUS:79960124011
SN - 1544-6794
VL - 9
SP - 105
EP - 112
JO - Journal of Supportive Oncology
JF - Journal of Supportive Oncology
IS - 3
ER -