RECRUITING

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

Description

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.

Conditions

Vasomotor Symptoms
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Related Conditions:

Vasomotor Symptoms

Study Overview

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Study Details

Study overview

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.

Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.

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

Condition
Vasomotor Symptoms
Intervention / Treatment

-

Contacts and Locations

Atlanta

Department of Gynecology & Obstetrics, Emory University School of Medicine, Atlanta, Georgia, United States, 30329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Known hypersensitivity to asimadoline TP0052.
  • * Chronic liver or renal disease, or uncontrolled seizure disorder.
  • * Use of medications or supplements that act as an inhibitor of P-glycoprotein or as a P-glycoprotein substrate during the 4 weeks prior to Screening Visit 1, including cyclosporine, non-topical ketoconazole, verapamil, digoxin, colchicine, sitagliptin).
  • * Blood test results indicating:
  • * Liver function tests: AST ≥2 times upper limit of normal; ALT ≥2 times upper limit of normal; total bilirubin ≥ 1.5 times upper limit of normal
  • * Kidney function test: estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m²
  • * Blood count: hematocrit \<30%.

Ages Eligible for Study

40 Years to 62 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tioga Pharmaceuticals,

Anne Dunlop - Principal Investigator, MD, PRINCIPAL_INVESTIGATOR, Emory University

Sergey Sikora, VP of Clinical Affairs, PhD, STUDY_CHAIR, Tioga Pharmaceuticals

Study Record Dates

2027-02-20