A Phase 2 interventional study of Asimadoline in Vasomotor Symptoms, sponsored by Tioga Pharmaceuticals. Recruiting at 1 site in United States. Open to female participants aged 40 Years to 62 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Tioga Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Tioga Pharmaceuticals is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 8, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Criteria for Menopause:
Criteria for Late Perimenopause:
Women with a uterus who have had consecutive intervals of amenorrhea of at least 60 days for three or more cycles (i.e., three consecutive episodes of vaginal bleeding separated by 60 or more days between vaginal bleeding episodes).
VMS frequency in week 2 cannot drop by more than 50% from the average weekly level reported during week 1.
Exclusion Criteria
Use of hormone therapy or hormonal (with the exception of the LNG IUD) during the 8 weeks before Screening Visit 1. Use of low-dose vaginal estrogen therapies is allowed, with the exception of vaginal creams used >3 times a week.
- For perimenopausal participants with a uterus and at least one ovary, an effective non-hormonal method of contraception must be used throughout study participation. Acceptable methods include barrier contraception, copper intrauterine device, surgical sterilization of the male partner, or true abstinence. Hormonal contraceptives remain prohibited, with the exception of levonorgestrel-releasing intrauterine devices (LNG IUDs), as specified above.
Any current severe or unstable medical illness, including the following:
Trial-Specific Exclusion Criteria:
Blood test results indicating:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Asimadoline
Placebo two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily for 8 weeks.
Drug: 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.
Also known as: TP0052
Safety as Assessed by Adverse Events, Clinical Laboratory Parameters, and Vital Signs
Safety will be evaluated based on the incidence and severity of adverse events and changes from baseline in laboratory values and vital signs. Adverse events will be graded using the Common Terminology Criteria for Adverse Events, Version 5.0 (grade 1 = mild; grade 5 = death; higher scores indicate worse outcomes). Liver function tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin. Higher values indicate worse liver function. Kidney function will be assessed by estimated glomerular filtration rate (scale: 0 to ≥90 mL/min/1.73 m²; \<60 considered abnormal; higher is better). Hematocrit will be monitored (percent; \<30% is abnormal; higher is better within normal range). Vital signs include blood pressure, heart rate, respiratory rate, and oral temperature; higher blood pressure and heart rate indicate worse outcomes. A urine pregnancy test (positive or negative) will also be performed.
Time frame: baseline to 8 weeks
Change in Frequency of Moderate to Severe Vasomotor Symptoms (VMS)
The frequency of moderate and severe vasomotor symptoms (VMS) will be measured using participant-completed diaries (paper or electronic) recorded twice daily (morning and evening) from Baseline to Week 8. VMS frequency is defined as the number of moderate or severe hot flashes or night sweats reported per day. Moderate VMS: sensation of heat with sweating, without disruption of activity. Severe VMS: sensation of heat with sweating that causes cessation of activity or awakening at night. The outcome is calculated as the average number of moderate/severe VMS episodes per day, averaged over the 8-week treatment period. Due to protocol-defined eligibility criteria, all participants will report at least 40 moderate/severe VMS episodes per week at baseline. During treatment, the minimum possible observed value is 0 episodes/day. There is no fixed upper limit; values of 20-30 episodes/day may occur. Higher values indicate worse symptom frequency.
Time frame: Baseline to 8 weeks
Change in Severity-Weighted Vasomotor Symptom (VMS) Score (Composite Severity Index).
VMS severity will be assessed using a composite score derived from participant diaries recorded twice daily from Baseline to Week 8. Each VMS episode is assigned a severity score: Mild = 1 Moderate = 2 Severe = 3 Daily VMS severity scores are calculated as: (# Mild × 1) + (# Moderate × 2) + (# Severe × 3) Weekly averages of daily severity scores are computed for each participant. The average across the 8-week treatment period will serve as the outcome measure. Due to protocol-defined eligibility criteria, all participants will report ≥40 moderate/severe VMS episodes per week at baseline. During treatment, the minimum possible observed value is 0. There is no fixed upper limit; for example, 10 severe episodes per day would result in a score of 30. Higher scores indicate worse symptom severity.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in VMS (vasomotor symptoms) Bothersomeness Score
Participant-reported bothersomeness of vasomotor symptoms (VMS) will be assessed using a numeric rating scale completed twice daily (morning and evening) via VMS diaries from Baseline to Week 8. Scale: 0 (not bothersome at all) to 10 (extremely bothersome) Minimum = 0 Maximum = 10 Higher scores indicate greater VMS-related bother.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Sleep Quality Rating
Sleep quality will be assessed via participant-reported ratings recorded in daily VMS diaries twice daily (morning and evening) from Baseline to Week 8. Participants will indicate the degree to which VMS disrupted their sleep using a 0-10 numeric scale. Minimum score: 0 (no disruption to sleep) Maximum score: 10 (extreme disruption to sleep) Higher scores indicate worse sleep quality.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Menopause-Specific Quality of Life (MENQOL) Score.
Quality of life will be measured using the MENQOL questionnaire, a validated 29-item scale assessing four domains: vasomotor, psychosocial, physical, and sexual. Participants will complete the MENQOL at baseline and at Week 8. Scale range per item: 1 (not at all bothered) to 8 (extremely bothered) Overall score = mean of all item responses Minimum = 1 Maximum = 8 Higher scores indicate worse menopause-related quality of life.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Female Sexual Function Index (FSFI) Score.
Sexual functioning will be assessed using the FSFI questionnaire, a validated 19-item instrument covering desire, arousal, lubrication, orgasm, satisfaction, and pain. FSFI will be administered at Baseline and Week 8. Scale total range: 2 to 36 Minimum = 2 Maximum = 36 Higher scores indicate better sexual functioning.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Pain Intensity Rating.
Pain intensity will be assessed via participant self-report using a numeric rating scale (NRS), recorded at Baseline and Week 8. Participants will rate the severity of pain symptoms potentially associated with menopausal status or treatment effect. Minimum score: 0 (no pain) Maximum score: 10 (worst pain imaginable) Higher scores indicate worse pain.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Follicle Stimulating Hormone (FSH) Level.
Serum follicle stimulating hormone (FSH) levels will be measured at Baseline and Week 8 to assess hormonal changes related to treatment. Units: mIU/mL No fixed minimum or maximum; normal postmenopausal levels typically \>40 mIU/mL Directional hypothesis: decreasing FSH may correlate with treatment response.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Adiponectin Level
Serum adiponectin will be measured at Baseline and Week 8 to explore its correlation with VMS treatment response. Units: μg/mL Directional hypothesis: modulation may indicate metabolic effects of treatment Higher or lower values will be analyzed for association with response.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in C-Reactive Protein (CRP) Level
High-sensitivity CRP (hsCRP) will be measured at Baseline and Week 8 as a marker of systemic inflammation. Units: mg/L Typical reference range: \<3.0 mg/L Changes will be evaluated for correlation with treatment response.
Time frame: Baseline to 8 weeks
Exploratory Outcome Measure - Change in Leptin Level.
Serum leptin will be measured at Baseline and Week 8 to evaluate metabolic and hypothalamic correlates of treatment effect. Units: ng/mL
Time frame: Baseline to 8 weeks
Change From Baseline in Brachial Artery Flow-Mediated Dilation
Brachial artery flow-mediated dilation (FMD), expressed as a percentage, will be assessed in participants who elect to undergo the optional exploratory vascular assessments. Change from Baseline to Week 8 will be evaluated.
Time frame: Baseline and Week 8
Change From Baseline in Digital Pulse Amplitude Tonometry-Derived Hyperemic Response
Microvascular endothelial function will be assessed using the digital pulse amplitude tonometry (PAT)-derived hyperemic response in participants who elect to undergo the optional exploratory vascular assessments. Change from Baseline to Week 8 will be evaluated.
Time frame: Baseline and Week 8
Change From Baseline in Carotid-Femoral Pulse Wave Velocity
Carotid-femoral pulse wave velocity (PWV), expressed in meters per second, will be assessed as a measure of arterial stiffness in participants who elect to undergo the optional exploratory vascular assessments. Change from Baseline to Week 8 will be evaluated.
Time frame: Baseline and Week 8
Change From Baseline in Augmentation Index Normalized to 75 Beats per Minute
Augmentation index normalized to a heart rate of 75 beats per minute (AIx@75), expressed as a percentage, will be derived from radial pulse-wave analysis in participants who elect to undergo the optional exploratory vascular assessments. Change from Baseline to Week 8 will be evaluated.
Time frame: Baseline and Week 8
Plan to share: Yes — Description: De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Access will be granted following approval of a research proposal and execution of a data-sharing agreement. Data will be shared through a secure platform to ensure confidentiality and compliance with applicable regulations. The shared data may include clinical study reports, anonymized participant-level datasets, and relevant supporting documentation. Time Frame: Data will be available upon publication of the primary study results and for a period of 5 years thereafter. Access Criteria: Researchers must submit a detailed proposal outlining the intended use of the data. Proposals will be reviewed by an independent data-sharing committee. Approved researchers must adhere to ethical and security guidelines, ensuring proper data use in compliance with applicable laws and regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Asimadoline
Tioga Pharmaceuticals