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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Tioga Pharmaceuticals
Study ID
NCT07042516
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 62 Years
Healthy Volunteers
Not accepted

Interventions

  • Asimadoline — DRUG
    Asimadoline TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 8 weeks.

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Feb 20, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Asimadoline
    Asimadoline TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 8 weeks. Post-unblinding 4 weeks of open label administration, TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 4 weeks.
  • Placebo Comparator: Placebo
    Placebo two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily for 8 weeks.

Primary Outcome Measure

Safety as Assessed by Adverse Events, Clinical Laboratory Parameters, and Vital Signs [ Time Frame: baseline to 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Gynecology & Obstetrics, Emory University School of MedicineAtlantaGeorgia30329
Tanja Associate Director, MA
[email protected]
(404) 712-5063

Find similar trials in Atlanta, GA

By condition
Menopause
By specialty
Women's healthFertility
By research site
Department of Gynecology & Obstetrics, Emory University School of Medicine· Atlanta, GA

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