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Clinical Trial
. 2011 May-Jun;9(3):105-12.
doi: 10.1016/j.suponc.2011.02.005.

A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA

Charles L Loprinzi  1 , Ernie P Balcueva, Heshan Liu, Jeff A Sloan, Lisa A Kottschade, Philip J Stella, Mark D Carlson, Dennis F Moore Jr, Robin T Zon, Ralph Levitt, Anthony J Jaslowski
Affiliations
Clinical Trial

A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA

Charles L Loprinzi et al. J Support Oncol. 2011 May-Jun.

Abstract

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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Figures

Figure 1
Figure 1
Patient Consort Diagram
Figure 2
Figure 2
Changes from baseline in vaginal dryness scores over study weeks by study arm
See this image and copyright information in PMC

References

    1. Pastore LM, Carter RA, Hulka BS, Wells E. Self-reported urogenital symptoms in postmenopausal women: Women's Health Initiative. Maturitas. 2004;49(4):292–303. - PubMed
    1. Dennerstein L, Dudley EC, Hopper JL, Guthrie JR, Burger HG. A prospective population-based study of menopausal symptoms. Obstet Gynecol. 2000;96(3):351–8. - PubMed
    1. Ganz PA, Greendale GA, Petersen L, Zibecchi L, Kahn B, Belin TR. Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial. J Natl Cancer Inst. 2000;92(13):1054–64. - PubMed
    1. Knobf MT. The menopausal symptom experience in young mid-life women with breast cancer. Cancer Nurs. 2001;24(3):201–10. quiz 10–1. - PubMed
    1. Leclair DM, Anandarajah G. Effects of Estrogen Deprivation: Vasomotor Symptoms, Urogenital Atrophy, and Psychobiologic Effects. Menopause (New York, NY) 2002;4(1):27–39.

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