TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women with Vulvar and Vaginal Atrophy: The REJOICE Trial. Issue 12 (1st December 2016)

• Record Type: Journal Article
• Authors: Kingsberg, Sheryl A.; Derogatis, Leonard; Simon, James A.; Constantine, Ginger D.; Graham, Shelli; Bernick, Brian; Gasper, Gina; Mirkin, Sebastian
• Is Part Of: Journal of sexual medicine. Volume 13:Issue 12(2016)
• Page Start: 1930
• Page End: 1937
• Publication Date: 2016-12-01
• Subjects: Estradiol -- Estrogen Therapy -- Female Sexual Function Index -- Female Sexual Dysfunction -- Menopause -- Vaginal Atrophy; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1016/j.jsxm.2016.09.002
• Languages: English
• ISSNs: 1743-6095

Abstract

ABSTRACT: Introduction: TX-004HR is an investigational, applicator-free, vaginal soft gel capsule containing low-dose solubilized 17β-estradiol. The phase 3, randomized, double-blinded, placebo-controlled, multicenter REJOICE trial has shown TX-004HR to be safe and effective for the treatment of moderate to severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy (VVA). Aim: To evaluate the effect of TX-004HR on female sexual dysfunction in postmenopausal women with VVA. Methods: The REJOICE study compared the effects of 12-week treatment with TX-004HR (4, 10, or 25 μg) with placebo in postmenopausal women (40–75 years old) with VVA and a most bothersome symptom of moderate to severe dyspareunia. Changes in the percentage of superficial and parabasal cells, vaginal pH, and dyspareunia were measured as co-primary end points. Female sexual dysfunction was evaluated as a secondary end point using the Female Sexual Function Index (FSFI) patient self-report inventory. Main Outcome Measures: Changes from baseline to week 12 in total and individual domain FSFI scores for each TX-004HR dose were compared with those for placebo. Results: All three TX-004HR doses increased the baseline total FSFI score after 12 weeks, with 10 μg ( P < .05) and 25 μg ( P = .0019) having a significantly greater effect than placebo. A similar trend was observed for the individual FSFI domains, with 10 and 25 μg significantly improving baselines scores for pain and lubrication at 12 weeks ( P ≤ .015 for all vs placebo). Changes from baseline to week 12 in arousal ( P = .0085) and satisfaction ( P = .0073) were significantly greater for TX-004HR 25 μg vs placebo. All three TX-004HR doses were comparable to placebo in their effect on desire and orgasm. Conclusion: TX-004HR improved FSFI scores in a dose-dependent manner. The observed improvements in sexual function suggest that TX-004HR is a promising treatment option for postmenopausal VVA with a potential added beneficial effect on female sexual dysfunction.