Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Public ClinicalTrials.gov record NCT07042516. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2a randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of asimadoline (TP0052), a peripherally restricted selective kappa-opioid receptor agonist, for moderate to severe menopausal vasomotor symptoms (VMS) in women aged 40-62 years. Following screening and baseline VMS diary collection, eligible participants are randomized 1:1 to oral asimadoline 5 mg twice daily or matching placebo for 8 weeks. Following the double-blind treatment period, all participants receive 4 weeks of open-label asimadoline, with a safety telephone assessment at approximately Week 12. Participants enrolled following implementation of Protocol Version 3.0 may elect to undergo optional noninvasive vascular assessments at Baseline and Week 8. These include brachial artery flow-mediated dilation (FMD), digital pulse amplitude tonometry (PAT), carotid-femoral pulse wave velocity (PWV), and radial pulse-wave analysis, including augmentation index normalized to a heart rate of 75 beats per minute (AIx@75). These exploratory assessments evaluate endothelial function, arterial stiffness, and central hemodynamics. Participation is voluntary, and participants may decline or discontinue the vascular assessments without affecting eligibility for or continued participation in the main study.
Study identification
- NCT ID
- NCT07042516
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 62 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2025 (Actual)
- Primary completion
- Oct 31, 2027 (Estimated)
- Completion
- Dec 31, 2027 (Estimated)
- Last update posted
- Oct 8, 2026
2025 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Department of Gynecology & Obstetrics, Emory University School of Medicine | Atlanta | Georgia | 30329 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07042516, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07042516 live on ClinicalTrials.gov.