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TherapeuticsMD Phase 1 Pilot Study Shows TX-12-004-HR Estradiol VagiCap Improves Conditions Of Vulvar And Vaginal Atrophy (VVA)

“Current estrogen therapies are antiquated. We are looking to leverage new technology to remove common and frustrating application and compliance issues related to legacy products. We believe the market is ripe for innovation and will grow significantly,” said Robert G. Finizio, Co-Founder and Chief Executive Officer of TherapeuticsMD.

The value of vaginally-administered estrogen therapy for women with moderate to severe VVA was recently re-affirmed in a 2013 Position Statement of The North American Menopause Society.

About the Study

This phase 1 pilot study sponsored by TherapeuticsMD was designed to evaluate the efficacy and safety of TX 12-004-HR in treating moderate to severe symptoms of VVA associated with menopause after 14 days of treatment, and to estimate the effect size and variability of VVA endpoints. Participants included 48 postmenopausal women (mean age 62.3 years) with at least one self-assessed symptom of vulvar and/or vaginal atrophy and meeting all other entry criteria were randomized in a 1:1 ratio to receive either TX 12-004-HR or a placebo VagiCap. Clinical evaluations were performed during the screening period at baseline (day 1 of the study) and on days 8 and 15. Serial blood samples for estradiol levels were collected on day 1 at 0, 1.0, 3.0 and 6.0 hours relative to administration of the first dose. Participants self-administered their assigned treatment intra-vaginally once daily at approximately the same time each morning. The primary efficacy analyses included all 48 women who completed the study.

Key findings of the study were evaluated by standard statistical methods and concluded that, as compared to the placebo group, women treated with TX 12-004-HR showed:
  • Statistically significant improvements in the Maturation index which included significant decreases in parabasal cells (p<0.0001);
  • Significant increases in superficial cells (p=0.0002) and in intermediate cells (p=0.0017);
  • Statistically significant decreases in vaginal pH (p=0.0002); and,
  • A significant reduction in the atrophic effects on epithelial integrity and vaginal secretions.

Although this study was not powered to demonstrate significant improvement in subjective symptoms such as vaginal dryness, irritation and pain during sexual activity, the treatment group demonstrated marginal improvement in the severity of these subjective symptoms.

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