An Open Label, Prospective, Randomized, Three Arm Parallel Study to Compare the Clinical Efficacy, Safety, and Tolerability of L Arginine plus Fenugreek, Tadalafil plus L Arginine Plus Fenugreek, and Tadalafil plus Testosterone in the Treatment of Erectile Dysfunction in Elderly Diabetic Patients
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Change in total IIEF-5 score from baseline to 12 weeks
Study Overview
Brief Summary
This study aims to compare the Clinical Efficacy, Safety, and Tolerability of L-Arginine + Fenugreek, Tadalafil + L-Arginine + Fenugreek, and Tadalafil + Testosterone in the Treatment of Erectile Dysfunction in Elderly Diabetic Patients. The primary objective is to compare the clinical efficacy of L-Arginine + Fenugreek, Tadalafil + L-Arginine + Fenugreek, and Tadalafil + Testosterone in improvement of IIEF-5 score in elderly diabetic patients with erectile dysfunction.
The secondary objective is to compare the safety and tolerability of L-Arginine + Fenugreek, Tadalafil + L-Arginine + Fenugreek, and Tadalafil + Testosterone in elderly diabetic patients with erectile dysfunction. The study is designed as a prospective, Interventional, Randomized, Open-label, Parallel Group, Comparative, Multicentric. The study population consist of patients in the age group of ≥50 years diagnosed with elderly diabetic patients with erectile dysfunction.
The study visit will be as per the following schedule:
Visit 1 (Day 0): Screening, Randomization, Enrollment, Baseline assessment, and Treatment initiation
Visit 2 [Day 28 (4 weeks) ± 7 days]: Follow-up visit
Visit 3 [Day 56 (8 weeks) ± 7 days]: Follow-up visit
Visit 4 [Day 84 (12 weeks) ± 7 days]: 48 hrs after end of treatment; End-of-study visit
Unscheduled visit: As required (during study participation)
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 50.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Male aged ≥50 years
- •Controlled type 2 diabetes mellitus (based on Investigator’s judgement)
- •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’)
- •Total IIEF-5 score less than 22 at enrollment
- •In a stable and active monogamous heterosexual relationship for at least 6 months prior to enrollment
- •Willingness to provide written informed consent.
Exclusion Criteria
- •Uncontrolled type 2 diabetes mellitus (HbA1C greater than 9%)
- •Known diagnosis of a sexual disorder other than ED
- •Regular smoking [at least one cigarette (or equivalent) per day]
- •Alcohol abuse [less than 4 drinks on any day or greater than 14 drinks per week]
- •Drug abuse (excessive, maladaptive, or addictive use of drugs for nonmedical purposes, as judged by the Investigator)
- •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
- •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
- •Clinically significant proliferative diabetic retinopathy
- •Clinically significant sexually transmitted diseases, carcinoma, acquired immunodeficiency syndrome, tuberculosis, congenital abnormalities of genital organs, peptic ulcer, hydrocele, or spinal cord lesions
- •Stroke or myocardial infarction within 6 months prior to enrollment
- •History of ketoacidosis within 3 years prior to enrollment
- •Pharmacotherapy for ED with any of the study medications within 30 days prior to enrollment
- •Pharmacotherapy for ED with any drug other than study medications within 6 months prior to enrollment
- •Known allergy, hypersensitivity, proven inefficiency, or contraindications to any of the study medications or products containing any of the study medications
- •Chronic intake of central nervous system or antiandrogen drugs
- •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
- •Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
- •Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Outcomes
Primary Outcomes
Change in total IIEF-5 score from baseline to 12 weeks
Time Frame: Day 0 & weeks 12
Secondary Outcomes
- 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)(Day 0, Week 12)
- 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)(Day 0, Week 12)
- Change in total IIEF-5 score from baseline to 4 and 8 weeks(Day 0, Week 4 & Week 8)
- 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 12(Day 0, Week 12)
- Changes in fasting blood sugar and HbA1C from baseline to 12 weeks(Day 0 & weeks 12)
- Proportion of subjects with adverse events and serious adverse events(Day 0, Week 4, Week 8 & Week 12)
- Subject-rated improvement (worsened, no change, or improved) at the end of 12 weeks of treatment(Week 12)
Investigators
Nagashankar N
Fourrts (India) Laboratories Pvt. Ltd.