Health Condition 1: E106- Type 1 diabetes mellitus with other specified complications Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Tadalafil 10mg, Tadalafil 20 mg: Participants will be randomly allocated to one of the two 12-week treatment arms: placebo / Tadalafil 10mg. If after one month of therapy and at least 4
Sponsors
GSVM Medical College
Eligibility
Inclusion criteria
Inclusion criteria: a. Men aged 18 years to 60 years both inclusive with a clinical diagnosis of type 1 or type 2 diabetes, a minimum 3-month history of mild-to-severe ED, and a stable monogamous relationship with a female partner will be eligible b. A clinical diagnosis of diabetes was predicated on either current therapy with insulin, metformin, or sulfonylureas or a history within the previous year of two occasions of diagnostic-level hyperglycemia, including 1) fasting plasma, serum, or blood glucose 126 mg/dl; 2) randomly obtained plasma, serum, or blood glucose 200 mg/dl) associated with symptoms of polyuria, polydipsia, or unexplained weight loss; or 3) plasma, serum, or blood glucose 200 mg/dl) 2 h after administration of 75 g oral glucose. c. Any patient with an onset of diabetes before the age of 30 years who had received continuous insulin treatment since diagnosis will be considered to have type 1diabetes. d. Men with a history of hypertension and hypercholesterolemia will be included. e. Patients will be eligible for study inclusion irrespective of previous responses to ED treatments, including sildenafil. f. men with micro-vascular complications, including retinopathy, will remain eligible g. Anticipate having same adult female sexual partner during the study. h. Agree to make at least 2 sexual intercourse attempts with the female partner during the 2 week run-in phase without medication. i. Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of two attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization. j. Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.
Exclusion criteria
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| a. Included the changes from baseline to end point in mean scores on IIEF-Q3 (penetration ability) and IIEF-Q4 (maintenance ability) in each treatment group. b. Proportions of patients achieving more than a five-point gain from baseline to end point in the erectile function domain of the IIEF were also determined for all treatment groups. Timepoint: at the end of 12 week treatment period | — |
Primary
| Measure | Time frame |
|---|---|
| a. Efficacy - i. IIEF - The effects of tadalafil on erectile function were evaluated using the International Index of Erectile Function (IIEF), a 15-item questionnaire that assesses five domains of male sexual function using 5- to 6-point Likert scales, with 0 or 1 signifying a low frequency or ability and 5 signifying a high frequency or ability. These domains include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. ii. Patients also used Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) diaries to record their sexual experiences. The treatment satisfaction will be measured by the EDITS indexTimepoint: a. Efficacy - i. IIEF - The effects of tadalafil on erectile function were evaluated using the International Index of Erectile Function (IIEF), a 15-item questionnaire that assesses five domains of male sexual function using 5- to 6-point Likert scales, with 0 or 1 signifying a low frequency or ability and 5 signifying a high frequency or ability. These domains include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. ii. Patients also used Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) diaries to record their sexual experiences. The treatment satisfaction will be measured by the EDITS index | — |
Countries
India
Contacts
Public ContactDr Saurabh Agarwal
GSVM Medical College
Outcome results
None listed