TY - JOUR
T1 - TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women With Vulvar and Vaginal Atrophy
T2 - The REJOICE Trial
AU - Kingsberg, Sheryl A.
AU - Derogatis, Leonard
AU - Simon, James A.
AU - Constantine, Ginger D.
AU - Graham, Shelli
AU - Bernick, Brian
AU - Gasper, Gina
AU - Mirkin, Sebastian
N1 - Publisher Copyright:
© 2016 The Authors
PY - 2016/12/1
Y1 - 2016/12/1
N2 - 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.
AB - 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.
KW - Estradiol
KW - Estrogen Therapy
KW - Female Sexual Dysfunction
KW - Female Sexual Function Index
KW - Menopause
KW - Vaginal Atrophy
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U2 - 10.1016/j.jsxm.2016.09.002
DO - 10.1016/j.jsxm.2016.09.002
M3 - Article
C2 - 27692842
AN - SCOPUS:84998817198
SN - 1743-6095
VL - 13
SP - 1930
EP - 1937
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 12
ER -