Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).

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, b…