Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR. Issue 8 (August 2017)

• Record Type: Journal Article
• Authors: Kingsberg, Sheryl A.; Kroll, Robin; Goldstein, Irwin; Kushner, Harvey; Bernick, Brian; Graham, Shelli; Mirkin, Sebastian; Constantine, Ginger D.
• Is Part Of: Menopause. Volume 24:Issue 8(2017)
• Publication Date: 2017-08
• Subjects: Acceptability -- Estradiol -- Genitourinary syndrome -- Menopause -- Satisfaction -- Vulvar and vaginal atrophy; Menopause -- Periodicals; 618.175005
• DOI: 10.1097/GME.0000000000000848
• Languages: English
• ISSNs: 1072-3714

Abstract

Abstract: Objective: TX-004HR is an investigational, muco-adhesive, vaginal, softgel capsule containing low-dose, solubilized, 17β-estradiol designed to treat postmenopausal vulvar and vaginal atrophy (VVA) and improve user experience without an applicator and less mess. Methods: As part of the 12-week, placebo-controlled, double-blind, phase 3 REJOICE trial evaluating the efficacy/safety of 4-, 10-, and 25-μg TX-004HR in 764 postmenopausal women with VVA, a five-question product survey was administered. Pearson correlation coefficients were used to evaluate correlations between clinical endpoints (vaginal physiology, dyspareunia, and vaginal dryness) and patient acceptability and satisfaction. Results: Majority of the women receiving TX-004HR or placebo reported that the product was easy to use (85.4%-92.1%) and rated ease of capsule insertion as "good" to "excellent" (75.0%-82.6%). A significantly greater percentage of women reported being "very satisfied" or "satisfied" with TX-004HR (68.6%-76.3%) than with placebo (56.8%, P < 0.05 for all). A greater percentage of women "somewhat" or "very much" preferred TX-004HR over their previous treatment versus those taking placebo ( P < 0.05). Significantly more women receiving TX-004HR (72.8%-80.5%) versus placebo (62.5%, P < 0.05) would "probably" or "definitely" consider using the product again. Dyspareunia and vaginal dryness reductions were correlated with higher product satisfaction and the percentage of women who would consider re-using TX-004HR. Conclusions: TX-004HR had a high level of product acceptability, and more women were satisfied with TX-004HR, preferred it over their previous treatment, and would consider using it again versus placebo. Women may find TX-004HR to be a more acceptable product than current options to treat their dyspareunia associated with postmenopausal VVA.