Evaluation of the effect of celexib that added to standard treatment of erectile dysfunction
Design
Clinical trial with control group, with parallel group, three-way blind, randomized, phase 3 on 50 patients. For randomization, sealed envelopes containing standard drug and placebo as well as similar envelopes containing standard drug and celexib were used.
Settings and conduct
This study will be performed on patients referring to urology clinics of Ghaem and Imam Reza hospitals who have referred due to erection disorder. This study will be randomized-Clinical-Trial. Eligible patients after obtaining informed consent are randomly divided into two groups: 1- The group that in addition to the standard treatment of 5 mg daily tadalafil, will also receive 200 mg of celexib. The group that will receive only the standard 5 mg daily tadalafil treatment with celexib 200 mg placebo. Blinding will be performed for both groups of patients and the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study include the following:
Existence of erection disorder in the patient according to the International Index of Erectile Function Questionnaire.
Criteria for non-inclusion in the study include the following:
Diabetes and heart failure and kidney failure (GFR disorder), patients with mental disorders, concomitant rheumatic diseases, concomitant use of other NSAIDs
Intervention groups
Patients with erectile dysfunction according to the International Erection Index Questionnaire.
Main outcome variables
Increasing the effectiveness of treatment with the addition of celexib in patients with erectile dysfunction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N7
Registration date:2021-03-16, 1399/12/26
Registration timing:retrospective
Last update:2021-03-16, 1399/12/26
Update count:0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Salman Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2553
Email address
soltanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Synergetic effect of Celexib & Tadalafil on Erectile Function in Pateint with Erectile Dysfunction
Public title
Evaluation of Synergetic effect of Celexib & Tadalafil on Erectile Function in Pateint with Erectile Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of erection disorder
Exclusion criteria:
Diabetes
Heart Failure
Kidney failure (GFR disorder)
History of mental disorder
Simultaneous rheumatic disease
Taking other NSAIDs
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization using sealed envelopes containing standard drug and placebo in one series of envelopes and standard drug and celecoxib in another series of envelopes whose sequence was done randomly with the contents of the envelope from the participant and the researcher and Hidden from clinical caregiver.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants are explained that in addition to standard treatment, the accidental patient may receive additional treatment and will not know whether they will receive additional standard treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Imam Reza Hospital Research Center, Mashhad, Imam Reza Square , Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.720
Health conditions studied
1
Description of health condition studied
Male erectile dysfunction
ICD-10 code
N52.9
ICD-10 code description
Male erectile dysfunction, unspecified
Primary outcomes
1
Description
Percentage Of Patient Discharged From The Erectile Dysfunction
Timepoint
60 Days
Method of measurement
Elimination of erection disorder based on the International Index of Erectile Function Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In addition to standard treatment (5 mg daily tadalafil), the group also consumes 200 mg celexib daily for up to 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: One group received only standard treatment (5 mg tadalafil daily) for 8 weeks.