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Tests treatment safety and results for Vasomotor Symptoms
Official title Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
ClinicalTrials.gov ID: NCT07042516
What this study is testing
What is Asimadoline?
Asimadoline is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for vasomotor symptoms.
Also referred to as TP0052.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 62, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Use of non-hormonal medications that can influence VMS during the 4 weeks before Screening Visit 1, including selective serotonin reuptake inhibitors...
- Use of marijuana or cannabis-derived products (including THC or CBD in any form other than topical, including smoked, vaporized, or edible) that can...
- Use of supplements or herbal therapies that can affect VMS including black cohosh, red clover, dong quai, evening primrose oil, maca, ginseng...
- 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)
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- Pregnancy, intending pregnancy, breast feeding.
- Current participation in another drug trial or intervention study.
- Inability or unwillingness to complete the study procedures. Trial-Specific Exclusion Criteria:
- 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...
- 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%.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 62 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.