Health Condition 1: N521- Erectile dysfunction due to diseases classified elsewhere
Conditions
Interventions
Intervention1: Argin ED (L-Arginine 800mg + Fenugreek 200mg) for 12 weeks: Patients will be treated with 3 tablets of Argin ED (L-Arginine
800mg + Fenugreek 200mg) once daily after dinner for 12 weeks
Sponsors
Fourrts (India) Laboratories Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male aged =50 years 2. Controlled type 2 diabetes mellitus (based on Investigator’s judgement) 3. ED for at least 3 months prior to enrollment (ED defined as ‘a history of persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance’) 4. Total IIEF-5 score less than 22 at enrollment 5. In a stable and active monogamous heterosexual relationship for at least 6 months prior to enrollment 6. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Uncontrolled type 2 diabetes mellitus (HbA1C greater than 9%) 2. Known diagnosis of a sexual disorder other than ED 3. Regular smoking [at least one cigarette (or equivalent) per day] 4. Alcohol abuse [less than 4 drinks on any day or greater than 14 drinks per week] 5. Drug abuse (excessive, maladaptive, or addictive use of drugs for nonmedical purposes, as judged by the Investigator) 6. Clinically significant hypertension, hypotension, major hematological disease, renal disease, hepatic diseases, macroalbuminuria, chronic prostatitis, neurological diseases, coronary heart disease, peripheral or cerebrovascular disease, endocrine diseases, hypogonadism, hyperprolactinemia, history of pelvic trauma or surgery, or major psychiatric disorders 7. Clinically significant penile deformities (or with penile implants), total erectile failure, testes hypotrophy, fibrotic anomalies in the penis, phimosis, Peyronie s disease, or history of surgical procedures associated with penis 8. Clinically significant proliferative diabetic retinopathy 9. Clinically significant sexually transmitted diseases, carcinoma, acquired immunodeficiency syndrome, tuberculosis, congenital abnormalities of genital organs, peptic ulcer, hydrocele, or spinal cord lesions 10. Stroke or myocardial infarction within 6 months prior to enrollment 11. History of ketoacidosis within 3 years prior to enrollment 12. Pharmacotherapy for ED with any of the study medications within 30 days prior to enrollment 13. Pharmacotherapy for ED with any drug other than study medications within 6 months prior to enrollment 14. Known allergy, hypersensitivity, proven inefficiency, or contraindications to any of the study medications or products containing any of the study medications 15. Chronic intake of central nervous system or antiandrogen drugs 16. Ongoing treatment with or requirement of any medications during trial participation that may contain any of the following: nitrates, estrogens, antiandrogens, anxiolytic drugs, LH-RH analogs, or tricyclic antidepressants 17. Participation in another clinical trial within past 30 days 18. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests 19. Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total IIEF-5 score from baseline to 12 weeksTimepoint: Day 0 & weeks 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in free serum testosterone level (in nmol/L) from baseline (prior to medication administration) to 12 weeks (48 hrs after the last dose of medication)Timepoint: Day 0, Week 12;Change in total IIEF-5 score from baseline to 4 and 8 weeksTimepoint: Day 0, Week 4 & Week 8;Change in total serum testosterone level (in nmol/L) from baseline (prior to medication administration) to 12 weeks (48 hrs after the last dose of medication)Timepoint: Day 0, Week 12;Changes in fasting blood sugar and HbA1C from baseline to 12 weeksTimepoint: Day 0 & weeks 12;Proportion of subjects with adverse events and serious adverse eventsTimepoint: Day 0, Week 4, Week 8 & Week 12;Proportion of subjects with severe (IIEF-5 score 5–7), moderate (IIEF-5 score 8–11), mildto- moderate (IIEF-5 score 12–16), and mild (IIEF-5 score 17–21) ED at baseline and at week 12Timepoint: Day 0, Week 12;Subject-rated improvement (worsened, no change, or improved) at the end of 12 weeks of treatmentTimepoint: Week 12 | — |
Countries
India
Contacts
Public ContactNagashankar N
Fourrts (India) Laboratories Pvt. Ltd.
Outcome results
None listed