E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
проучване за оценка на ефикасността и безопасността на перорален Tribestan при мъже с еректилна дисфункция (лека до умерена степен) и/или понижено либидо (вторично хипоактивно сексуално желание) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061461 |
E.1.2 | Term | Erectile dysfunction |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024419 |
E.1.2 | Term | Libido decreased |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
▪ 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.
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E.2.2 | Secondary objectives of the trial |
▪ To evaluate the effect of Tribestan on the level of Total cholesterol, LDL, HDL, triglycerides. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
▪ Race: Caucasians;
Sex: male;
▪ Age: > 18 < 65 years;
Disease
a) Erectile Dysfunction (ED) ≥ 6 months duration; mild (Score 17–25), moderate (Score 11–16);
b) And/or Secondary hypoactive sexual desire;
c) Compliance – understand and is willing, able and likely to comply with study procedures and restrictions;
d) Consent – is capable of understanding the study procedures, patient obligation as well as risks and benefits of participation in this study and has given written informed consent.
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E.4 | Principal exclusion criteria |
•Age >65< 18 years;
•Genital anatomical deformities;
•ED secondary to spinal cord injury;
•Severe (Score 0–10) ED;
•Primary diagnosis of other sexual disorders, including primary hypoactive sexual desire;
•Prolactin level > 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 <50/min; clinically significant ECG abnormalities);
•Hypotension - blood pressure <90/50 mmHg;
•Hypertension – blood pressure >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 (Clcr<25 ml/min, or creatinine >180 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Това проучване ще сравни ефикасността и безопасността на Tribulus terrestris (Tribestan®) спрямо плацебо при мъже с лека до умерена еректилна дисфункция и/или понижено либидо. |
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E.5.2 | Secondary end point(s) |
Overall estimation of sexual function by IIEF;
Adverse Events monitoring;
Laboratory measurements;
Lipids profile;
Blood pressure
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Both Sopharma and the Principle Investigator reserve the right to terminate the study at any time. Should be necessary, the procedures will be arranged after review and consultation by both parties. In terminating the study, Sopharma and and the Principal Investigator will asure that adequate consideration is given to the protection of the patient`s interests.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |