National Institutes of Health State-of-the-Science Conference statement: management of menopause-related symptoms.
National Institutes of Health
https://pubmed.ncbi.nlm.nih.gov/15968015Actively Recruiting
Phase 2
Age: 40Years - 62Years
FEMALE
ID07042516
Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women
Led by Tioga Pharmaceuticals · Updated on 2025-09-09
120
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Who Can Participate
Age: 40Years - 62Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female aged 40 to 62 years
- Untreated patients newly diagnosed with vasomotor symptoms or with a history but no recent use of certain medications affecting VMS
- Menopausal or late perimenopausal status defined by specific clinical and hormonal criteria
- At least 40 moderate to severe vasomotor symptoms per week during screening
- 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 levonorgestrel IUD) within 8 weeks before screening
- Use of non-hormonal medications affecting VMS within 4 weeks before screening
- Use of marijuana or cannabis-derived products affecting VMS within 4 weeks before screening
- Use of supplements or herbal therapies known to affect VMS within 4 weeks before screening
- Severe or unstable medical illnesses including stage 2 or greater hypertension, resting heart rate over 100, current cancer diagnosis (except non-melanoma skin cancer), abnormal breast or Pap smear findings, coronary artery or cerebrovascular disease
- Substance use disorder, recent suicide attempt, major depressive episode, psychosis, or bipolar disorder history
- Pregnancy, intending pregnancy, or breastfeeding
- Participation in another drug or intervention trial
- Unable or unwilling to complete study procedures
- Known hypersensitivity to asimadoline TP0052
- Chronic liver or kidney disease or uncontrolled seizure disorder
- Use of medications that inhibit or are substrates of P-glycoprotein within 4 weeks before screening
- Abnormal blood test results indicating liver, kidney, or blood count issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive Asimadoline or placebo tablets twice daily for 8 weeks to treat moderate to severe menopausal vasomotor symptoms.
Weekly visits for up to 8 weeks
Follow-up
Duration - 4 weeks
After initial treatment, participants in the Asimadoline group receive an additional 4 weeks of open-label Asimadoline treatment.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Department of Gynecology & Obstetrics, Emory University School of Medicine
Atlanta, Georgia, United States, 30329
Actively Recruiting
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Research Team
S
Standish Fleming, CEO, MBA
G
Garet Heintz, Regulatory Consultant and Agent, RAC
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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