Condition: Vasomotor Symptoms · Sponsor: Tioga Pharmaceuticals
This Randomized Clinical Trial entitled Safety and Efficacy of a Peripherally Restricted Selective Kappa Agonist for Moderate to Severe Menopausal Symptoms in Midlife Women is a Phase 2a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of asimadoline TP0052 for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). The design includes: 2 weeks of daily recording of VMS prior to drug treatment; 8 weeks of double-blind treatment with the peripherally restricted kappa agonist (PRKA), asimadoline TP0052, or placebo; and a safety telephone follow-up post-treatment; after the initial 8-week double-blinded follow-up, all patients undergo treatment with Asimadoline in an open label format for 4 weeks.
This description comes directly from the study's public registry record.
Standish Fleming, CEO, MBA · (858) 245-7563 · fleming@tiogapharma.com
Garet Heintz, Regulatory Consultant and Agent, RAC · 858-571-1800 · gheintz@therapeuticsinc.com
Always discuss trial participation with your own doctor first.
| Department of Gynecology & Obstetrics, Emory University School of Medicine | Atlanta, Georgia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07042516