N95.1
Conditions
Interventions
Group 1: Improvement in score of menopausal symptoms using the Menopausal Rating Scale.
End-point: Change from baseline and week 12 in Menopause Rating Scale (MRS) Total Score and in each of the 11 sy
Sponsors
Chemo Group
Eligibility
Sex/Gender
Female
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Female patients, age = 50 years and being menopausal according to clinical symptoms 2. FSH (> 50 mIU/mL) and Estradiol (< 30 pg/mL) 3. Written informed Consent
Exclusion criteria
Exclusion criteria: 1. Current BMI > 35 kg/m2 2. Patients with severe acute or chronic diseases (e.g. pancreatitis, hypertriglyceridemia, liver disease, malign or benign tumor of the liver, malign sex-hormone-dependent diseases of the genital or the breast) 3. Migraine with Aura 4. Intake of drugs, which induce microsomal enzymes, especially cytochrome-P450, e.g. phenytoine, phenobarbital, pyrimidon, bosentan, carbamazepin, rifampicin, topiramate, felbamate, griseofulvine, some HIV protease inhibitors (e.g. ritonavir) und non-nucleosidic inhibitors of reverse transciptase (e.g. efavirenz) and androgen receptor (AR) antagonists (e.g. enzalutamide). 5. History of cardiocascular disease 6. Advanced high blood pressure or diabetes mellitus 7. Existence or known risk for venous or arterial thromboembolism 8. Non-diagnosed abnormous vaginal bleeding 9. Use of drugs containing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir during the study period and two weeks in advance 10. Pregnancy and Breast feeding during the study period 11. Allergy to one of the compounds of the product 12. Concomitant use of other nutritional products or female sexual hormones during the study and 8 weeks before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in score of menopausal symptoms using the Menopausal Rating Scale. End-point: Change from baseline and week 12 in Menopause Rating Scale (MRS) Total Score and in each of the 11 symptoms on the MRS scale. The change in menopause rating scale (MRS) total score compared with baseline at week 12 equals MRS total score at week 12 minus MRS total score at baseline. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44. Secondary variable: Change From Baseline in Menopause Rating Scale Total Score and in each of the 11 symptoms on the MRS scale [Time Frame: at baseline and week 4]. | — |
Countries
Romania, Spain
Contacts
Public ContactPedro-Antonio Regidor
Exeltis Healthcare
Outcome results
None listed