male libido failure MedDRA version: 9.1 Level: PT Classification code 10024419
Conditions
Interventions
Trade Name: MIRAPEXIN
Pharmaceutical Form: Tablet
INN or Proposed INN: Pramipexole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .18-
Pharmaceutical form of the p
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Pazients aged 20-60 coming to the Urological outpatient clinic of Gemelli Universitary Hospital with complaint of libido failure since more than three months 2. Associated erectile dysfunction 3. Delayed ejaculation , anorgasmy 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: 1. Vasculogenic erectile dysfunction assessed by color-doppler ultrasound , or neurogenic erectile dysfunction after pelvic surgical procedures 2. Iatrogenic delayed ejaculation due to tamsulosine or to seminal pathways obstruction 3. Patients treated with anti-depressant, anti-psychotic ,anxiolytic drugs. 4. Renal failure 5. Oncologic pathologies 6. Higher and lower urinary tract symptoms 7. Pituitary dysfunctions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate clinical effects of pramipexole on eugonadic or hypoganadic Patients with male libido failure;Secondary Objective: To evaluate clinical effects of Pramipexole on erectile function , delayed ejaculation and on anorgasmy. - To evaluate seric testosterone and LH levels after dopaminergic drugs therapy;Primary end point(s): Variation from the baseline of the scores of the questionnaires (IIEF-15 , SF- 36) due to pramipexole treatment. | — |
Countries
Italy
Outcome results
None listed