vasomotor symptoms vms
Conditions
Interventions
Fezolinetant 45 mg 1 tab orally once daily,Desvenlafaxine 50 mg 2 tabs orally once daily
Active Comparator Drug,Active Comparator Drug
Fezolinentant,desvenlafaxine
Sponsors
faculty of medicine, prince of songkla university
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1 Women age more than 45 years old with natural menopause or surgical menopause from nonmalignant gynecologic condition 2 Woman with at least 7 episodes of moderate to severe VMS per day or 50 to 60 per week and symptoms persist at least 1 week before recruitment. 3 No co-existing hormonal used within 3 month
Exclusion criteria
Exclusion criteria: Thyroid disease - Contraindication of fezolinetant - AST/ALT > 2x upper normal limit or total bilirubin > 2x upper normal limit - Severe renal impairment or end-stage renal disease - Concomitant use with CYP1A2 inhibitors during the trial - Anticonvulsant: Phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate - Antifungal: ketoconazole, itraconazole, fluconazole, voriconazole, griseofulvin - Antidepressant: fluvoxamine, fluoxetine - Antiretroviral drug: ritonavir, saquinavir, indinavir, nelfinavir - Other: erythromycin, clarithromycin, diltiazem, rifampicin, verapamil - Allergy to fezolinetant - Contraindication of desvenlafaxine - Concomitant use with MAOIs inhibitors - Severe hepatic impairment - Severe renal impairment or end-stage renal disease - Allergy to desvenlafaxine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vasomotor symptoms 3 month Mean calculation of frequency of moderate-to -severe VMS per day | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life 3 month menqol | — |
Countries
Thailand
Contacts
Public ContactKunfa Sompongnawakit
prince of songkla university
Outcome results
None listed