Menopausal syndrome MedDRA version: 8.1 Level: LLT Classification code 10058825 Term: Menopausal disorder
Conditions
Interventions
Product Name: genistin daidzin glycitin
Product Code: 7153
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: 7153
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
ZAMBON GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 61485;Post menopausal women aged between 40-65, with at least 6 months since the last menstrual period or 6 weeks from bilateral oophorectomy, and the serum levels of FSH 8805; 30 IU/L and estradiol 8804; 40 pg/ml at baseline. 61485;Patients with a minimum average of 5 moderate to severe hot flushes including night sweats in 24h during the last 7 days on patient s diary before randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 61485;Concomitant therapies such as Hormone Replacement Therapy HRT and any other hormone therapies estrogens, progesterone, androgens in the last 3 months before the inclusion into the study; other agents for the treatment of hot flushes such as megestrol acetate, clonidine, vitamin E, phenobarbital, ergotamine tartrate, antidepressant agents and patients habitually taking 4 days a week products containing isoflavones in the last month before screening visit. 61485;Patients with severe hepatic failure AST and ALT twice the upper limit , renal failure creatinine 1.5 mg/dl , diabetes mellitus type I or uncontrolled type II , uncontrolled dysthyroidism, manifest heart failure condition NYHA II-IV , severe neurologic diseases, as well as patients with hypersensitivity to soy products. 61485;Patients with previous breast cancer in the last 5 years or suspected breast nodules at physical examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show superiority of a 12 week treatment with Zavital over placebo in reduction of frequency of hot flushes in post-menopausal women;Secondary Objective: 61485;To evaluate the efficacy of a 12 week treatment with Zavital in reduction of intensity of vasomotor symptoms 61485;To evaluate the efficacy of a 12 week treatment with Zavital in reduction of all climacteric symptoms Greene Climacteric Scale 61485;To evaluate the safety of a 12-week treatment with Zavital in terms of incidence of adverse events, vital signs and laboratory evaluations. 61485;To evaluate the global efficacy and tolerability of a 12-week treatment with Zavital ;Primary end point(s): The primary efficacy variable is the change from baseline in the mean daily frequency of moderate and severe hot flushes during the last 7 days on patient s diary prior to visit of mid-treatment 6th week , first of all, and secondly at the end-of treatment 12th week | — |
Countries
Italy
Outcome results
None listed