CTRI/2024/05/067557Not yet recruitingPhase 4
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 - NI
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility 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
- •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
Investigators
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