| CTRI Number |
CTRI/2021/10/037629 [Registered on: 27/10/2021] Trial Registered Prospectively |
| Last Modified On: |
25/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Tadalfil on Erectile Dysfunction among North Indian Males with Diabetes Mellitus. |
|
Scientific Title of Study
|
Effect of Tadalfil on Erectile Dysfunction among North Indian Males with Diabetes Mellitus-A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Fahad Ali |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College |
| Address |
Department of Medicine
GSVM Medical College,
Swaroop Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7897515354 |
| Fax |
|
| Email |
alifahad.12295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Agarwal |
| Designation |
Associate Professor Medicine |
| Affiliation |
GSVM Medical College |
| Address |
Room no 5
Department of Medicine
GSVM Medical College
Swaroop Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415039582 |
| Fax |
|
| Email |
dragarwalsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Agarwal |
| Designation |
Associate Professor Medicine |
| Affiliation |
GSVM Medical College |
| Address |
Room no 5,
Department of Medicine
GSVM Medical College
Swaroop Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415039582 |
| Fax |
|
| Email |
dragarwalsaurabh@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical College Kanpur |
|
|
Primary Sponsor
|
| Name |
GSVM Medical College |
| Address |
Swaroop Nagar, Kanpur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Fahad Ali |
Room No 5, Department of Medicine |
GSVM Medical College
Swaroop Nagar, Knapur
Kanpur Nagar
UTTAR PRADESH |
7897515354
alifahad.12295@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College Kanpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Matching placebo will be give in placebo group. If after one month of therapy and at least 4 attempts at sexual intercourse the response is not satisfactory as assessed by EDITS (Patient version) the dose will be doubled. |
| Intervention |
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 attempts at sexual intercourse the response is not satisfactory as assessed by EDITS (Patient version) the dose of Placebo/Tadalafil will be doubled. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
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.
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 |
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
at the end of 12 week treatment period |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Erectile dysfunction (ED) is a common comorbidity in patients with diabetes. As many as 60- 75% of diabetic men will experience at some time in their lives with a consistent or recurrent inability to achieve and maintain an erection adequate for sexual performance. Ed is observed as normal aging process also, however diabetic patients encounter ED typically at an earlier age than their counterparts with normal glycemic control. Not only does diabetes increase the risk of ED nearly twofold, but ED may also be the first symptom of diabetes and may significantly predict of neuropathic symptoms and poor glycemic control. It is also associated with lowered confidence and self respect. Although improvement in erectile function (EF) is paramount in the treatment of erectile dysfunction (ED), the impact of the disease is multifaceted, and includes a myriad of physical and psychosocial aspects not addressed by improvement of EF alone. In fact, one of the first concerns of men who choose to undergo treatment is for their partner’s sexual satisfaction. Tadalafil, a potent, selective and reversible inhibitor of phosphodiesterase type 5 has been approved as an oral therapy for erectile dysfunction. Tadalafil has a time to maximum concentration of 2 h and a half-life of 17·5 h. The efficacy of tadalafil taken once daily, its impact on men’s sexual satisfaction, confidence and self-esteem, or their female partner’s satisfaction, has not yet been much among North Indian population. Therefore this trial aims at finding efficacy, safety of Tadalafil in North Indian subjects suffering from T2DM. |