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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
A study for postmenpausal women with symptoms of moderate to severe vaginal pain associated with sexual activity using study drug TX-004HR
| Sponsor: | TherapeuticsMD |
| Enrolling: | Female Patients Only |
| Study Length: | 6 Months |
| Clinic Visits: | 5 |
| IRB Number: | AAAO3300 |
| U.S. Govt. ID: | NCT02253173 |
| Contact: | Luz Sanabria: 212-305-9672 / ls2328@cumc.columbia.edu |
Additional Study Information:
The purpose of this study is test a new investigational vaginally inserted hormone drug product called TX-004HR on postmenopausal women who have symptoms of vulvar and vaginal atrophy (VVA). After menopause, the amount of estrogen circulating throughout a woman's body decreases and can result in changes in their vaginal tissue known as vulvar and vaginal atrophy or VVA. This study will determine the safety and effectiveness of this drug and if it works in treating certain symptoms of VVA.
This study is closed
