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
Rogerio Lobo, MD, FACOG
Do You Qualify?
Do you have moderate to severe symptoms of vaginal pain associated with sexual activity? Yes No
Are you currently sexually active? Yes No
Are you currently using any hormonal treatments? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Luz Sanabria