Authors: Kessel B.¹; Nachtigall L.¹; Plouffe L.²; Siddhanti S.²; Rosen A.²; Parsons A.³

Source: Climacteric, Volume 6, Number 3, 1 September 2003 , pp. 248-256(9)

Publisher: Informa Healthcare

Abstract:

Objective: To determine the effects of raloxifene on sexual function in postmenopausal women with pre-existing vaginal atrophy treated with vaginal estrogen cream.

Methods: A total of 187 naturally postmenopausal women, 42-80 years of age, with signs of genitourinary atrophy were enrolled in this 6-month, multicenter, parallel-group study. Subjects were randomized to oral raloxifene HCl 60 mg daily or matching placebo; the same subjects were also randomized to receive one application of either vaginal conjugated estrogen cream 0.5 g twice weekly for 6 months or non-hormonal vaginal moisturizer twice weekly for 3 months, followed by conjugated estrogen cream for 3 months. Both investigators and subjects were masked to the identity of the oral medication. The vaginal preparations were administered in an open-label fashion. The Sexual Activity Questionnaire (SAQ) was administered at baseline and at 3 and 6 months. Safety was assessed throughout the study.

Results: A total of 102 women were sexually active at baseline and, of these, 82 were also sexually active at the 6-month end-point. At 6 months, raloxifene and placebo, in the presence of vaginal conjugated estrogen cream, were both associated with improvement from baseline in vaginal dryness and reduced discomfort during sexual activity. There were no significant differences between raloxifene and placebo groups in any SAQ item. Enjoyment of sexual activity significantly increased from baseline with raloxifene but not with placebo. No difference in adverse events was observed between groups.

Conclusion: Raloxifene had no negative effects on sexual function in postmenopausal women with vaginal atrophy who were treated concomitantly with vaginal estrogen cream.

Keywords: RALOXIFENE VISTA REMARIN EPLENS VAGINAL ATROPHY; SEXUAL ACTIVITY; SEXUAL ACTIVITY; QUESTIONNAIRE

Document Type: Original article

Affiliations: 1: Department of Obstetrics, Gynecology and Women's Health, John A. Burns School of Medicine, University of Hawaii, Queen's Medical Center, Honolulu, Hawaii 2: Eli Lilly, Indianapolis, Indiana 3: University of South Florida College of Medicine, Department of Obstetrics and Gynecology, Tampa, Florida, USA

Publication date: 2003-09-01

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