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Randomized Controlled Trial
. 2017 Aug;24(8):894-899.
doi: 10.1097/GME.0000000000000848.

Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR

Sheryl A Kingsberg  1 , Robin Kroll, Irwin Goldstein, Harvey Kushner, Brian Bernick, Shelli Graham, Sebastian Mirkin, Ginger D Constantine
Affiliations
Randomized Controlled Trial

Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR

Sheryl A Kingsberg et al. Menopause. 2017 Aug.

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.

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Figures

FIG. 1
FIG. 1
Women's satisfaction with TX-004HR. P value versus placebo.
FIG. 2
FIG. 2
Treatment preference over previously used vulvar and vaginal atrophy treatments. P value versus placebo.
FIG. 3
FIG. 3
Likelihood of using TX-004HR again. P value versus placebo.
See this image and copyright information in PMC

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