Evaluating Asimadoline TP0052 for Treating Moderate to Severe Menopausal Symptoms in Women Aged 40 to 62

What this Trial Is About

This research evaluates the safety and effectiveness of asimadoline TP0052, a peripherally restricted selective kappa agonist, for treating moderate to severe menopausal vasomotor symptoms VMS in midlife women. It is a Phase 2a randomized, double-blind, placebo-controlled clinical trial focusing on women aged 40 to 62 who experience significant menopausal symptoms. The study aims to better understand how asimadoline affects these symptoms compared to placebo. Participants are randomly assigned to receive either asimadoline TP0052 or a placebo for 8 weeks. The asimadoline group takes 2.5 mg tablets twice daily, totaling 10 mg daily two tablets on awakening and two before bed. Following the double-blind period, all participants receive asimadoline openly for an additional 4 weeks at the same dosage. This design allows researchers to compare effects during blinded treatment and observe safety and symptom changes during open-label administration. During the study, participants will record their vasomotor symptoms daily for 2 weeks before starting treatment. Researchers will monitor safety through adverse events, lab tests, and vital signs over the 8 weeks of blinded treatment. They will also assess changes in frequency and severity of symptoms. After treatment, a safety follow-up call is conducted. Overall participation includes screening, 8 weeks of blinded treatment, 4 weeks of open-label treatment, and safety monitoring.

Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).