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NCT07042516 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
A Phase 2 study of Vasomotor Symptoms, sponsored by Tioga Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07042516 is a Phase 2 study of Vasomotor Symptoms that is actively recruiting participants, run by Tioga Pharmaceuticals. The registered enrollment target is 120 participants, below the 184-participant average among 8 other Vasomotor Symptoms trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07042516, a Phase 2 study of Vasomotor Symptoms, is actively recruiting participants, sponsored by Tioga Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Asimadoline
Study Locations (1)
Georgia
- Department of Gynecology & Obstetrics, Emory University School of Medicine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-08-13 |
| Est. Completion | 2027-02-20 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07042516
The ClinicalTrials.gov registry entry for NCT07042516 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 8 other Vasomotor Symptoms trials with a reported enrollment target (35% lower). The listed sponsor is Tioga Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Vasomotor Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Asimadoline is the first listed.
NCT07042516 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT07042516 about?
NCT07042516 is a clinical study titled "Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).". 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 t...
What is the current status of trial NCT07042516?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-08-13. Estimated completion is 2027-02-20.
What conditions does trial NCT07042516 study?
This clinical trial studies the following conditions: Vasomotor Symptoms.
What interventions are being tested in trial NCT07042516?
The interventions under investigation include: Asimadoline (DRUG).
Who is sponsoring clinical trial NCT07042516?
This trial is sponsored by Tioga Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07042516 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.