This Phase IV, 16 weeks study will be multicenter, randomized, double-blind, placebo-controlled. It will evaluate the efficacy and safety of Tribestan compared to placebo in men with erectile dysfunction and/or secondary low libido. MedDRA version: 14.1 Level: PT Classification code 10061461 Term: Erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 14.1 Level: PT Classification code 10024419 Term: Libido decreased System Organ Class: 100
Conditions
Interventions
Trade Name: Tribestan film-coated tablet 250 mg
Product Name: TRIBESTAN film coated tablets 250 mg
Product Code: HS1304613
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tribulus Terrest
Sponsors
SOPHARMA PLC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Race: Caucasians; Sex: male; ? Age: > 18 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Age >65 2 times the upper limit of the normal range or increased level of prolactin with non clear aetiology; •Total testosterone level > 20% below the lower limit of the normal range (blood samples will be collected between 8-10h in fasting condition); •uncontrolled major psychiatric disorder; •Diabetes mellitus I type or II type poorly controlled or associated with proliferative retinopathy – HbA1c> 7%; •History of stroke, myocardial infarction within the past 1 year or severe and unstable cardiovascular disease (angina, chronic heart failure with symptoms at rest, sick-sinus syndrome or conduction deficits like sino-atrial block, atrio-ventricular block II or III degree; bradicardia 170/100 mmHg; •Clinically significant Chronic Pulmonary Disease or bronchial asthma within 1 year before the enrollment; •History of present active gastritis, active ulcer disease or dyspepsia; •Clinically significant hematological abnormalities; •Severe renal insufficiency (Clcr180 µmol/l); •Hepatic insufficiency indicated by: ASAT, ALAT, ALP or GGT > 3 times the upper limit of the normal range; •Benign prostate hyperplasia; •Prostate cancer; •Known hypersensitivity to Tribulus terrestris or other ingredients; •History of chronic alcohol or drug abuse or treatment for them; •Positive tests to HIV, HBsAg and HCV; •Concomitant medications, containing testosterone, drugs known to be causally associated with ED, androgen therapy or any other treatments for ED, lipid lowering agents and diuretics. •Participated in another clinical trial during the study period or within the past three months. •Not will to give written Informed Consent Form; •Patient, who, in the ivestigator`s opinion, would not comply with Clinical Trial Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To compare the efficacy and safety of Tribestan vs placebo on erectile function and sexual desire in men with erectile dysfunction and/or low libido. ? To monitor the safety profile of Tribestan. ;Secondary Objective: ? To evaluate the effect of Tribestan on the level of Total cholesterol, LDL, HDL, triglycerides.;Primary end point(s): The primary endpoint is the change of erectile function score, evaluated by IIEF after 12 weeks treatment period with Tribestan film-coated tablets after meal. IIEF is a standardized questionnaire for evaluation of erectile function with score ranges from 0 to 30 (1-5 and 15 question). Higher score indicates better sexual function.;Timepoint(s) of evaluation of this end point: ???? ????????? ?? ?????? ???????????? ? ????????????? ?? Tribulus terrestris (Tribestan®) ?????? ??????? ??? ???? ? ???? ?? ??????? ????????? ?????????? ?/??? ???????? ??????. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall estimation of sexual function by IIEF; Adverse Events monitoring; Laboratory measurements; Lipids profile; Blood pressure ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Bulgaria
Contacts
Public ContactVesselin Hristov
PRS EOOD
Outcome results
None listed