Efficacy, Safety, and Tolerability of Argin ED in the Treatment of Erectile Dysfunction in Elderly Diabetic Patients

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total IIEF-5 score from baseline to 12 weeksTimepoint: Day 0 & weeks 12

Secondary Outcome Measures

Name	Time	Method
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