Postmenopause MedDRA version: 9.1 Level: LLT Classification code 10051775 Term: Postmenopause
Conditions
Interventions
Trade Name: PROGYNOVA*20CPR RIV 2MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Estradiol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) regular menstrual cycles; b) presence of both ovaries; c) surgical procedure of bilateral annessiectomy. 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: a) treatment with estrogens, estroprogestins or GnRH analogues in previous 3 months; b) oligoamenorrhoea; c) hypertension; d) diabetes mellitus; e) smoke; f) hyperlipidemia; g) obesity; h) positive medical history of cardiovascular diseases; i) positive medical history of malignant diseases; renal insufficiency, cerebrovascular diseases; l) therapy with statins, low-dose aspirin and erythropoietin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine correlation between levels of circulating endothelial progenitor cells (EPCs) and estrogens, in women of fertile age and in postmenopause.;Secondary Objective: Assess plasmatic levels of LH, FSH, estradiol, sex hormone binding globulin and hemochrome for evaluating absolute number of EPCs.;Primary end point(s): Assess levels of endothelial progenitor cells (EPCs) before and after removal of ovaries and in case after estrogens substitutive therapy, in women of fertile age submitted to surgical ovariectomy. | — |
Countries
Italy
Outcome results
None listed