CTRI/2017/03/008014 [Registered on: 06/03/2017] Trial Registered Prospectively
Last Modified On:
23/11/2018
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical Study to Compare the Efficacy and Safety of Vardenafil Tablet as compared with Sildenafil Tablet in Treatment of Erectile Dysfunction
Scientific Title of Study
A Multicentric, Double Blind, Randomized, Active Control, parallel, non-inferiority Clinical study to evaluate Efficacy, Safety of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of erectile dysfunction.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Vikash Kumar
Designation
Principal Investigator
Affiliation
Lokmanya Tilak Municipal Medical College & General Hospital
Address
Lokmanya Tilak Municipal Medical College & General Hospital,
Sion West,
Mumbai-400022.
Maharashtra.
Mumbai MAHARASHTRA 400022 India
Phone
09820163302
Fax
Email
drvikashkumar2010@gmail.com
Details of Contact Person Scientific Query
Name
Dr Shailesh Singh
Designation
Vice President R&D and Reg. Affairs
Affiliation
Ajanta Pharma Ltd
Address
Ajanta Pharma Ltd
Advent 43AB/44CD Charkop Industrial Estate Kandivli West
Mumbai
MAHARASHTRA
400067
India
Department Of Urology, B. J. Medical College & Civil Hospital,
Ward A-1, Ground Floor, Asarwa, Ahmedabad – 380016.
Gujarat. Ahmadabad GUJARAT
9824086834
drshreniks@gmail.com
Dr Narendra Kulkarni
Dr. Hedgewar Hospital
Department of Urology,
Dr. Hedgewar Hospital,
Garkheda, Aurangabad-431005
Maharashtra. Aurangabad MAHARASHTRA
09822435520
narendra-kulkarni@hedgewar.org
Prof Dr Rajeev Sood
Dr. Ram Manohar Lohia Hospital and Post Graduate Institute of Medical
Department of Urology,
Dr. Ram Manohar Lohia Hospital and Post Graduate Institute of Medical,
Ground Floor, OPD Block, Baba Kharag Singh Marg,
New Delhi-110001 New Delhi DELHI
01123361228
drsoodr@gmail.com
Dr Vijoy Kumar
Indira Gandhi Institute of Medical Sciences
Indira Gandhi Institute of Medical Science, Sheikhpura, Patna-800014. Patna BIHAR
9939040277
dr.vijoy.kumar@gmail.com
Dr Ajit Saxena
Indraprastha Apollo Hospitals
Department of Urology,
Indraprastha Apollo Hospitals,
Mathura Road, Sarita Vihar,
New Delhi – 110076. New Delhi DELHI
09810111946
ajitsaxena@hotmail.com
Dr Dilip Kumar Pal
IPGME&R, SSKM Hospital
Department of Urology,
IPGME&R, SSKM Hospital,
244, Acharya Jagadish Chandra Bose Road,
Kolkata-700020.
West Bengal. Kolkata WEST BENGAL
09433132553
drdkpal@yahoo.co.in
Dr Sujata Patwardhan
KEM Hospital
Department of Urology,
8th Floor, New MSB Building, KEM Hospital, Parel,
Mumbai-400012.
Maharashtra. Mumbai MAHARASHTRA
9819075205
sujatapatwardhan@kem.edu
Dr S N Sankhwar
King George’s Medical University
Department of Urology,
King George’s Medical University,
Lucknow – 226003.
Uttar Pradesh. Lucknow UTTAR PRADESH
9335901693
sankhwarsn_sn@yahoo.com
Dr Satyen Dobhada
KMRF’S Nikop Hospital
Department of Urology,
KMRF’S Nikop Hospital, Ring Road, Phaltan-415523 Satara,
Maharashtra Satara MAHARASHTRA
09822097174
nikophospital59@gmail.com
Dr Sagar Sudhir Bhalerao
Lifepoint Multispecialty hospital
Department of Urlology,
Lifepoint Multispecialty hospital,
145/1, Mumbai Bangalore Highway, near Hotel Sayaji, Wakad,
Pune – 411057.
Maharashtra. Pune MAHARASHTRA
09422185735
bhalerao.sagar119@gmail.com
Dr Vikash Kumar
Lokmanya Tilak Municipal Medical College & General Hospital
Departmentof Urology,
Lokmanya Tilak Municipal Medical College & General Hospital,
Sion West,
Mumbai-400022.
Maharashtra. Mumbai MAHARASHTRA
09820163302
drvikashkumar2010@gmail.com
Dr H Krishna Moorthy
Lourdes Hospital
Department of Urology,
Lourdes Hospital
Pachalam,
Kochi – 682012.
Kerala. Ernakulam KERALA
04842393720
dr.moorthy65@gmail.com
Dr Ashok Kumar Gupta
Maharaja Agrasen Hospital
Maharaja Agrasen Hospital, Punjabi Bagh, New Delhi-110026 New Delhi DELHI
9810046353
akg.urogyn@gmail.com
Dr A Appalaraju
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital
Department of Surgery,
RIMS Government General Hospital, Srikakulam - 532001. Andhra Pradesh. Srikakulam ANDHRA PRADESH
9246666531
draappalaraju@gmail.com
Dr T R Gurunath
Ramana Maharishi Rangammal Hospital
Department of Urology,
Ramana Maharishi Rangammal Hospital,
Shiva Nagar, Athiyandal village,
Triuvannamalai-606603.
Tamil Nadu. Tiruvanamalai TAMIL NADU
041575236108
rmrh007@gmail.com
Dr Sudhir Khanna
Sir Ganga Ram Hospital
Department of Urology,
Sir Ganga Ram Hospital,
Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060. New Delhi DELHI
01142251498
sk1957@gmail.com
Dr Hemant Pathak
T.N. Medical College & B.Y.L. Nair Charitable Hospital
Department of Urology, T.N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai Central, Mumbai – 400008.
Maharashtra. Mumbai MAHARASHTRA
Sildenafil Tablets 50 mg One Tablet daily 1 hour prior to sexual activity for first 28 days.
After day 28 till 84 days Sildenafil Tablets 100 mg One Tablet daily 1 hour prior to sexual activity.
Dose escalation from 50 mg to Sildenafil Tablets 100 mg after 28 days in patients in which there is an increase of ≤ 4 unit points change in the IIEF - 5 score from the baseline.
Intervention
Vardenafil Tablets 10 & 20 mg
Vardenafil Tablets 10 mg
One Tablet daily 1 hour prior to sexual activity for first 28 days.
After day 28 till 84 days Vardenafil Tablets 20 mg
One Tablet daily 1 hour prior to sexual activity.
Dose escalation from 10 mg to Vardenafil Tablets 20 mg after 28 days in patients in which there is an increase of ≤ 4 unit points change in the IIEF - 5 score from the baseline.
Inclusion Criteria
Age From
21.00 Year(s)
Age To
65.00 Year(s)
Gender
Male
Details
1. Subjects who have provided their written informed consent.
2. Subjects between the age of 21 and 65 (both inclusive)
3. Subjects with heterosexual relationship, with history of normal sexual function.
4. History of Erectile Dysfunction for at least 4 weeks.
5. Subjects meeting with diagnostic criteria for erectile dysfunction as per the simplified international index of erectile function (IIEF-5) score lesser than 22 and more than 5.
6. Penile Doppler standard systolic and diastolic velocity range for inclusions (<25 cm/sec as definite arterial dysfunction and 25-30 cm/sec as borderline case.)
7. Subjects willing to participate in the study and follow visit schedule, including response to the questions related with the sexual function information for both himself and his spouse’s and information on sexual intercourse
ExclusionCriteria
Details
1. Subjects engaged in polygamy, anal penetration, and homosexual relationships.
2. Subjects and their female partner of the child bearing age who are not able to follow adequate contraceptive measures during the course of the study.
3. Subjects with history of or underlying cardiovascular condition, myocardial infarction, cardiac arrhythmia, heart failure, unstable angina, resting or postural hypotension or hypertension (Uncontrolled Hypertension 180/100 mmHg).
4. Primary hypoactive sexual desire, Spinal cord injury, Pelvic surgery Presence of penile anatomical abnormalities
5. Subjects for whom sexual activity is inadvisable because of their underling disease status.
6. Subjects having bleeding disorder.
7. Subjects with hereditary degenerative retinal disorders.
8. Subjects with history of loss of vision because of non-arteritic anterior ischemic optic neuropathy.
9. Subjects with abnormal laboratory values for Serum total testosterone level, Serum creatinine and Serum AST and/or ALT.
10. Subjects with history of cancer.
11. Subjects with history of chronic headache or migraine.
12. Subjects with History of Space occupying lesion in cranium.
13. Subjects with general neurasthenia, myasthenia, depression that required medical treatment, syncope or fainting episodes within 6 months of baseline visit or seizures, demyelinating neurological disorders.
14. Subjects with history of ototoxicity from any drug in the past or impaired hearing unless corrected surgically at least 6 months before the baseline visit.
15. Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e. defined as FPG levels of ≥125 mg/dL and Glycosylated HbA1C Level >7%).
16. Subjects with history of sexually transmitted diseases, HIV infection or AIDS, Hepatitis B & C, fungus infection requiring systemic antifungal.
17. Subjects with a positive VDRL test
18. Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, Itraconazole or ketoconazole, clarithromycin and erythromycin.
19. Subjects with history of alcohol or drug abuse.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
• To demonstrate efficacy of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of Erectile Dysfunction (ED) as demonstrated by the Index of Erectile Function (IIEF - 5) score.
• To demonstrate efficacy of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of Erectile Dysfunction (ED) as demonstrated by the Index of Erectile Function (IIEF - 5) score.
Secondary Outcome
Outcome
TimePoints
Percentage Changes in the proportion of population in the linear categories
(as described) of IIEF - 5 domain score at 4, 8, 12 weeks
At 4, 8, 12 weeks
Percentage Change in Success of Penetration from Baseline to the end of study.
At 4, 8, 12 weeks
Percentage Change in Success of Erection Maintenance throughout the intercourse from Baseline to the end of study.
At 4, 8, 12 weeks
Percentage Change in Ability to Ejaculate from Baseline to the end of study.
at 4, 8, 12 weeks
Target Sample Size
Total Sample Size="240" Sample Size from India="240" Final Enrollment numbers achieved (Total)= "227" Final Enrollment numbers achieved (India)="219"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is A Multicentric, Double Blind, Randomized, Active Control, parallel, non-inferiority Clinical study to evaluate Efficacy, Safety of Vardenafil Tablets as compared with Sildenafil Tablets in treatment of erectile dysfunction.
Primary objective of the study is to assess the mean change in IEFF-5 Score from baseline to end of study.
Secondary outcome of the study are as follows;
1.Assessment of Percentage Changes in the proportion of population in the linear categories of IIEF - 5 domain score at 4, 8, 12 weeks.
2.Assessment of Percentage Change in Success of Erection Maintenance throughout the intercourse from Baseline to the end of study.
3.Assessment of Percentage Change in Ability to Ejaculate from Baseline to the end of study.