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



To evaluate the effect of TX-004HR on female sexual dysfunction in postmenopausal women with VVA.



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.



Changes from baseline to week 12 in total and individual domain FSFI scores for each TX-004HR dose were compared with those for placebo.



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.



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.
OB/GYN Behavioral Medicine, University Hospitals Case Medical Center, Cleveland, OH, USA. Electronic address: Sheryl.Kingsberg@UHhospitals.org.
Sheryl A
SA
Kingsberg
Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Leonard
L
Derogatis
The George Washington University School of Medicine, Washington, DC, USA.
James A
JA
Simon
EndoRheum Consultants, LLC, Malvern, PA, USA.
Ginger D
GD
Constantine
TherapeuticsMD, Boca Raton, FL, USA.
Shelli
S
Graham
TherapeuticsMD, Boca Raton, FL, USA.
Brian
B
Bernick
TherapeuticsMD, Boca Raton, FL, USA.
Gina
G
Gasper
TherapeuticsMD, Boca Raton, FL, USA.
Sebastian
S
Mirkin
D000282:Administration, Intravaginal; D000368:Aged; D001284:Atrophy / Q000473:pathology; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy*; D004958:Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009948:Orgasm / Q000187:drug effects; D010549:Personal Satisfaction; D017698:Postmenopause; D014623:Vaginal Diseases / Q000188:drug therapy*; D014844:Vulva / Q000473:pathology
D004958:Estradiol
Estradiol; Estrogen Therapy; Female Sexual Dysfunction; Female Sexual Function Index; Menopause; Vaginal Atrophy