Phase 3 Trial Supports Investigational Drug for VVA

“TX-004HR was designed to rapidly and effectively treat all symptoms of vulvar and vaginal atrophy (VVA) without increasing serum E2 levels,” a collaborative team of researchers began in a new phase 3 study.

This investigational treatment is an applicator-free softgel capsule. It is indicated to help postmenopausal women with moderate-to-severe VVA and dyspareunia. Results from the trial were presented at The North American Menopause Society 27^th Annual Meeting (NAMS 2016) in Orlando, Florida.

The cohort included healthy menopausal women ages 40 to 75 with moderate-to-severe VVA and dyspareunia. Women administered TX-004HR (4 µg, 10 µg, and 25 µg) once per day for two weeks, followed by twice a week for 10 weeks.

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A four-point scale was used to assess various factors (0 = none, 1 = mild, 2 = moderate, 3 = severe) for vaginal color, vaginal epithelial integrity, vaginal epithelial surface thickness, and vaginal secretions.

At the beginning of the study, the average woman had 1.8 for vaginal color, 1.5 for epithelial integrity, 1.9 for epithelial surface thickness, and 1.7 for secretions. The team noted that these scores were consistent with moderate VVA.

“Significant improvements from baseline at weeks 2, 6, 8, and 12 were observed for all three doses of TX-004HR compared with placebo in vaginal color (white to pink), epithelial integrity, epithelial surface thickness, and secretions,” the report said. The participants in the treatment groups had average scores lower than 1 in all of the categories by the end of 12 weeks.

Visual examination further confirmed the benefits of the three different doses of TX-004HR. Negligible to very low systemic E2 absorption was observed.

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