Journal of Clinical Oncology, Vol 15, 969-973, Copyright © 1997 by American Society of Clinical Oncology
Phase III randomized double-blind study to evaluate the efficacy of a polycarbophil-based vaginal moisturizer in women with breast cancer
CL Loprinzi, S Abu-Ghazaleh, JA Sloan, C vanHaelst-Pisani, AM Hammer, KM Rowland Jr, M Law, HE Windschitl, JS Kaur and N Ellison
Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. cloprinzi@mayo.edu
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.
