Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
NCT ID: NCT07042516
Last Updated: 2025-09-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-08-13
Study Completion Date
2027-02-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Vasomotor Symptoms
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Sponsor
Study Groups
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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.
Group Type
EXPERIMENTAL
Asimadoline
Intervention Type
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.
Placebo
Placebo two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily for 8 weeks.
Group Type
PLACEBO_COMPARATOR
Asimadoline
Intervention Type
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.
Interventions
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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.
Intervention Type
DRUG
Other Intervention Names
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TP0052
Eligibility Criteria
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Inclusion Criteria
* Females aged 40-62 years.
* Untreated patients (either newly diagnosed with VMS or those with a history of VMS but have not been taking drugs that could have an effect on VMS (e.g., SSRIs, SNRIs, gabapentin, pregabalin, clonidine).
* Menopausal OR late perimenopausal according to the following criteria:
Criteria for Menopause:
* Women who have had a bi-lateral oophorectomy (\> 6 weeks prior); OR
* Women with a uterus who have had no vaginal bleeding the past 12 months; OR
* Women without a uterus (or women with a uterus who have either a levonorgestrel intrauterine device \[LNG IUD\] or who have had an endometrial ablation) and who still have one or both ovaries, with follicle stimulating hormone (FSH) level \> 40 mIU/mL and estradiol ≤ 50 pg/mL (on at least one of two blood draws two weeks apart);
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).
• At least 40 moderate to severe VMS per week for each of the 2 screening weeks, as reported on daily VMS diaries.
* Including at least 6 moderate to severe VMS per day on 4 or more days in each of the 2 screening weeks.
* VMS frequency in week 2 cannot drop by more than 50% from the average weekly level reported during week 1.
* In general good health as determined by medical history, blood pressure, and heart rate.
* Signed informed consent.
* Untreated patients (either newly diagnosed with VMS or those with a history of VMS but have not been taking drugs that could have an effect on VMS (e.g., SSRIs, SNRIs, gabapentin, pregabalin, clonidine).
* Menopausal OR late perimenopausal according to the following criteria:
Criteria for Menopause:
* Women who have had a bi-lateral oophorectomy (\> 6 weeks prior); OR
* Women with a uterus who have had no vaginal bleeding the past 12 months; OR
* Women without a uterus (or women with a uterus who have either a levonorgestrel intrauterine device \[LNG IUD\] or who have had an endometrial ablation) and who still have one or both ovaries, with follicle stimulating hormone (FSH) level \> 40 mIU/mL and estradiol ≤ 50 pg/mL (on at least one of two blood draws two weeks apart);
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).
• At least 40 moderate to severe VMS per week for each of the 2 screening weeks, as reported on daily VMS diaries.
* Including at least 6 moderate to severe VMS per day on 4 or more days in each of the 2 screening weeks.
* VMS frequency in week 2 cannot drop by more than 50% from the average weekly level reported during week 1.
* In general good health as determined by medical history, blood pressure, and heart rate.
* Signed informed consent.
Exclusion Criteria
* • Use of hormone therapy or hormonal contraceptives (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.
* Use of non-hormonal medications that can influence VMS during the 4 weeks before Screening Visit 1, including selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, and clonidine.
* Use of marijuana or cannabis-derived products (including THC or CBD in any form other than topical, including smoked, vaporized, or edible) that can affect central thermoregulatory processes, mood and perception of VMS, and potentially have pharmacodynamic interactions with the asimadoline during the 4 weeks before Screening Visit 1 as determined by interview and urine drug test.
* Use of supplements or herbal therapies that can affect VMS including black cohosh, red clover, dong quai, evening primrose oil, maca, ginseng, chasteberry, milk thistle, and phytoestrogens during the 4 weeks before Screening Visit 1.
* Any current severe or unstable medical illness, including the following:
* Hypertension of stage 2 or greater (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90)
* Resting heart rate \>100.
* Current cancer diagnosis, except non-melanoma skin cancer, or any findings suggestive of or indicating breast malignancy.
* Current abnormal Pap smear, breast exam, or mammogram.
* Coronary artery disease, or cerebrovascular disease.
* Moderate to severe substance use disorder in the previous 12 months; suicide attempt in the previous 36 months, any major depressive episode within the previous 12 months, or lifetime diagnosis of psychosis or bipolar disorder.
* Pregnancy, intending pregnancy, breast feeding.
* Current participation in another drug trial or intervention study.
* Inability or unwillingness to complete the study procedures.
* Known hypersensitivity to asimadoline TP0052.
* Chronic liver or renal disease, or uncontrolled seizure disorder.
* Use of medications or supplements that act as an inhibitor of P-glycoprotein or as a P-glycoprotein substrate during the 4 weeks prior to Screening Visit 1, including cyclosporine, non-topical ketoconazole, verapamil, digoxin, colchicine, sitagliptin).
* Blood test results indicating:
* Liver function tests: AST ≥2 times upper limit of normal; ALT ≥2 times upper limit of normal; total bilirubin ≥ 1.5 times upper limit of normal
* Kidney function test: estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m²
* Blood count: hematocrit \<30%.
* Use of non-hormonal medications that can influence VMS during the 4 weeks before Screening Visit 1, including selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, and clonidine.
* Use of marijuana or cannabis-derived products (including THC or CBD in any form other than topical, including smoked, vaporized, or edible) that can affect central thermoregulatory processes, mood and perception of VMS, and potentially have pharmacodynamic interactions with the asimadoline during the 4 weeks before Screening Visit 1 as determined by interview and urine drug test.
* Use of supplements or herbal therapies that can affect VMS including black cohosh, red clover, dong quai, evening primrose oil, maca, ginseng, chasteberry, milk thistle, and phytoestrogens during the 4 weeks before Screening Visit 1.
* Any current severe or unstable medical illness, including the following:
* Hypertension of stage 2 or greater (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90)
* Resting heart rate \>100.
* Current cancer diagnosis, except non-melanoma skin cancer, or any findings suggestive of or indicating breast malignancy.
* Current abnormal Pap smear, breast exam, or mammogram.
* Coronary artery disease, or cerebrovascular disease.
* Moderate to severe substance use disorder in the previous 12 months; suicide attempt in the previous 36 months, any major depressive episode within the previous 12 months, or lifetime diagnosis of psychosis or bipolar disorder.
* Pregnancy, intending pregnancy, breast feeding.
* Current participation in another drug trial or intervention study.
* Inability or unwillingness to complete the study procedures.
* Known hypersensitivity to asimadoline TP0052.
* Chronic liver or renal disease, or uncontrolled seizure disorder.
* Use of medications or supplements that act as an inhibitor of P-glycoprotein or as a P-glycoprotein substrate during the 4 weeks prior to Screening Visit 1, including cyclosporine, non-topical ketoconazole, verapamil, digoxin, colchicine, sitagliptin).
* Blood test results indicating:
* Liver function tests: AST ≥2 times upper limit of normal; ALT ≥2 times upper limit of normal; total bilirubin ≥ 1.5 times upper limit of normal
* Kidney function test: estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m²
* Blood count: hematocrit \<30%.
Minimum Eligible Age
40 Years
Maximum Eligible Age
62 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Tioga Pharmaceuticals
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Anne Dunlop - Principal Investigator, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Sergey Sikora, VP of Clinical Affairs, PhD
Role: STUDY_CHAIR
Tioga Pharmaceuticals
Locations
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Department of Gynecology & Obstetrics, Emory University School of Medicine
Atlanta, Georgia, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Garet Heintz, Regulatory Consultant and Agent, RAC
Role: CONTACT
858-571-1800 ext. 105
Facility Contacts
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References
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Other Identifiers
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IND#: 160,058
Identifier Type: OTHER
Identifier Source: secondary_id
IRB Tracking Number: 20250414
Identifier Type: OTHER
Identifier Source: secondary_id
TIOGA VMS-08
Identifier Type: -
Identifier Source: org_study_id
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TERMINATED
PHASE2
Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause
NCT01116310
UNKNOWN
PHASE4
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
NCT00446199
COMPLETED
PHASE3
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
NCT05312567
COMPLETED
PHASE2
A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause
NCT07160127
NOT_YET_RECRUITING
EARLY_PHASE1
A Nutritional Supplement on Vasomotor Symptoms in Women
NCT04516304
COMPLETED
NA
An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
NCT06949553
RECRUITING
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
NCT04090957
COMPLETED
PHASE3
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause
NCT04234204
COMPLETED
PHASE3
Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
NCT00560833
COMPLETED
PHASE3
Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms
NCT06787066
RECRUITING
EARLY_PHASE1
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
NCT03192176
COMPLETED
PHASE2
Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone
NCT00152438
UNKNOWN
PHASE2
Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women
NCT05813067
COMPLETED
NA