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

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.

• Authors: Sheryl A Kingsberg, Leonard Derogatis, James A Simon, Ginger D Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin
• Journal: The journal of sexual medicine (J Sex Med) Vol. 13 Issue 12 Pg. 1930-1937 (12 2016) ISSN: 1743-6109 [Electronic] Netherlands
• PMID: 27692842 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Estradiol

Topics

• Administration, Intravaginal
• Aged
• Atrophy (pathology)
• Double-Blind Method
• Dyspareunia (drug therapy)
• Estradiol (administration & dosage)
• Female
• Humans
• Middle Aged
• Orgasm (drug effects)
• Personal Satisfaction
• Postmenopause
• Vaginal Diseases (drug therapy)
• Vulva (pathology)