Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Eligible age
40–62 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Tioga Pharmaceuticals
You may qualify 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 (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:
You may not qualify 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 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.
- ✕ 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.
Where it's recruiting
Atlanta
Source: ClinicalTrials.gov · NCT07042516 · last updated 2026-10-08