Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer

Charles Lawrence Loprinzi, S. Abu-Ghazaleh, Jeff A Sloan, C. vanHaelst-Pisani, A. M. Hammer, K. M. Rowland, M. Law, H. E. Windschitl, Judith S Kaur, N. Ellison

Research output: Contribution to journalArticle

127 Citations (Scopus)

Abstract

Purpose: Vaginal dryness and dyspareunia are significant estrogen- depletion symptoms that affect many breast cancer survivors. The present trial was developed to evaluate the nonhormonal vaginal lubricating preparation, Replens, for alleviating these symptoms. Materials and Methods: A double-blind, crossover, randomized clinical trial was developed. Patients received 4 weeks of Replens (Columbia Research Laboratories, Rockville Centre, NY) followed by a 1-week washout period followed by 4 weeks of a placebo lubricating product, or vice versa. Weekly patient-completed diaries were used for measuring efficacies and toxicities of therapy. Results: The 45 assessable patients provided well-balanced treatment groups. During the first 4 weeks, average vaginal dryness decreased by 62% and 64% in the placebo and Replens groups, respectively (P = .3). Average dyspareunia scores also improved by 41% and 60%, respectively (P = .05). Crossover analysis indicated that the bulk of the beneficial effects appeared within the first 2 weeks of the first treatment and remained constant thereafter. Both treatments were relatively well tolerated. Conclusion: Both Replens and the placebo appear to substantially ameliorate vaginal dryness and dyspareunia in breast cancer survivors.

Original languageEnglish (US)
Pages (from-to)969-973
Number of pages5
JournalJournal of Clinical Oncology
Volume15
Issue number3
StatePublished - Mar 1997

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Dyspareunia
Double-Blind Method
Breast Neoplasms
Placebos
Survivors
Therapeutics
Estrogens
Randomized Controlled Trials
Replens
calcium polycarbophil
Research

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer. / Loprinzi, Charles Lawrence; Abu-Ghazaleh, S.; Sloan, Jeff A; vanHaelst-Pisani, C.; Hammer, A. M.; Rowland, K. M.; Law, M.; Windschitl, H. E.; Kaur, Judith S; Ellison, N.

In: Journal of Clinical Oncology, Vol. 15, No. 3, 03.1997, p. 969-973.

Research output: Contribution to journalArticle

Loprinzi, CL, Abu-Ghazaleh, S, Sloan, JA, vanHaelst-Pisani, C, Hammer, AM, Rowland, KM, Law, M, Windschitl, HE, Kaur, JS & Ellison, N 1997, 'Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer', Journal of Clinical Oncology, vol. 15, no. 3, pp. 969-973.
Loprinzi, Charles Lawrence ; Abu-Ghazaleh, S. ; Sloan, Jeff A ; vanHaelst-Pisani, C. ; Hammer, A. M. ; Rowland, K. M. ; Law, M. ; Windschitl, H. E. ; Kaur, Judith S ; Ellison, N. / Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer. In: Journal of Clinical Oncology. 1997 ; Vol. 15, No. 3. pp. 969-973.
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AU - Hammer, A. M.

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