Actively Recruiting
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Led by Tioga Pharmaceuticals · Updated on 2025-09-09
120
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 40 to 62 years.
- Untreated with drugs affecting vasomotor symptoms, including SSRIs, SNRIs, gabapentin, pregabalin, clonidine.
- Menopausal or late perimenopausal as defined by specific criteria including bi-lateral oophorectomy, absence of vaginal bleeding, or hormonal blood levels.
- At least 40 moderate to severe vasomotor symptoms per week during 2 screening weeks.
- At least 6 moderate to severe vasomotor symptoms per day on 4 or more days during each of the 2 screening weeks.
- Vasomotor symptom frequency in week 2 cannot drop by more than 50% from week 1 average.
- Generally good health based on medical history, blood pressure, and heart rate.
- Signed informed consent.
You will not qualify if you...
- Use of hormone therapy or hormonal contraceptives (except LNG IUD) within 8 weeks before screening.
- Use of non-hormonal medications affecting vasomotor symptoms within 4 weeks before screening.
- Use of marijuana or cannabis-derived products affecting thermoregulation or mood within 4 weeks before screening.
- Use of supplements or herbal therapies affecting vasomotor symptoms within 4 weeks before screening.
- Severe or unstable medical illnesses including stage 2 or greater hypertension, resting heart rate above 100, active cancer (except non-melanoma skin cancer), abnormal Pap smear, breast exam, or mammogram.
- Coronary artery or cerebrovascular disease.
- Recent substance use disorder, suicide attempt, major depressive episode, psychosis, or bipolar disorder.
- Pregnancy, intending pregnancy, or breastfeeding.
- Current participation in another drug or intervention study.
- Inability or unwillingness to complete study procedures.
- Known hypersensitivity to asimadoline TP0052.
- Chronic liver or kidney disease, or uncontrolled seizures.
- Use of medications affecting P-glycoprotein within 4 weeks before screening.
- Abnormal blood tests for liver function, kidney function, or low hematocrit.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Gynecology & Obstetrics, Emory University School of Medicine
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
S
Standish Fleming, CEO, MBA
CONTACT
G
Garet Heintz, Regulatory Consultant and Agent, RAC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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