Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.
Tioga Pharmaceuticals
Summary
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.
Eligibility
- Age range
- 40–62 years
- Sex
- Female
- Healthy volunteers
- No
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 devi…
Interventions
- DrugAsimadoline
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.
Location
- Department of Gynecology & Obstetrics, Emory University School of MedicineAtlanta, Georgia