TX-004HR is a novel, self-inserted (no applicator needed) vaginal softgel capsule (VagiCap™) containing solubilized 17-β estradiol under investigation for the treatment of moderate to severe postmenopausal dyspareunia. Phase 1 and 2 data suggests that TX-004HR may provide an effective dosage form with early onset of action and low systemic estrogen levels. The effect of TX-004HR on female sexual dysfunction (FSD) was assessed utilizing the Female Sexual Function Index (FSFI).METHODS:
A multicenter Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of TX-004HR. A total of 764 postmenopausal women with self-assessed moderate to severe dyspareunia received TX-004HR (4 µg, 10 µg, or 25 μg) compared to placebo for 12 weeks. Co-primary endpoints were change from baseline to week 12 in: percent superficial and parabasal cells, vaginal pH, and dyspareunia (the self-identified most bothersome symptom). Secondary endpoints included vaginal dryness and vaginal and/or vulvar itching or irritation and an assessment of sexual function, assessed by the FSFI questionnaire. The six individual FSFI domain scores (arousal, desire, orgasm, lubrication, satisfaction, and pain) and the overall score were analyzed as a secondary efficacy endpoint.RESULTS:
Results at Week 12 will be included in January.CONCLUSION:
TX-004HR, a vaginal softgel estradiol capsule when used in postmenopausal women with dyspareunia is expected to improve female sexual dysfunction as measured by the FSFI Index.