TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women With Vulvar and Vaginal Atrophy: The REJOICE Trial

Sheryl A. Kingsberg, Leonard Derogatis, James A. Simon, Ginger D. Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)1930-1937
Number of pages8
JournalJournal of Sexual Medicine
Volume13
Issue number12
DOIs
StatePublished - Dec 1 2016

Keywords

  • Estradiol
  • Estrogen Therapy
  • Female Sexual Dysfunction
  • Female Sexual Function Index
  • Menopause
  • Vaginal Atrophy

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

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