Evaluation of therapeutic effect of long acting testosterone ampule in Patients with androgen deficiency syndrome presented at urology clinics of Ahwaz.
Objective: Evaluation of therapeutic effect of testosterone ampoule in Patients with androgen deficiency syndrome presented at urology clinics of Ahwaz.
Methods: 24 patients above 40 years referred from the urology clinic with symptoms of sexual dysfunction recruited in this study. They were assessed with screening questionnaire (ADAM), detecting androgen deficiency syndrome, testosterone level was measured. If Testosterone level was below 6ng/ml, serum levels of PSA and cholesterol , Triglyceride ,HDL, LDL, and FBS andHbA1C and 2Hpp were requested. All eligible patients divided into two groups randomly: First group received four injection (testosterone enanthate 250mg) with two-week interval and the second one were three injections(testosterone enanthate 250mg) at 3-week intervals was done and finally after two months of the first visit patients was followed up again and lab tests were measured repeatedly.
General information
Acronym
″ADAMS″ ٬androgen deficiency in aging male
IRCT registration information
IRCT registration number:IRCT201104236258N1
Registration date:2011-05-22, 1390/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-22, 1390/03/01
Registrant information
Name
Naser Abaszade
Name of organization / entity
Ahwaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 46 1233 7926
Email address
abaszade.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Research & Technology, Ahwaz JundiShapur University of medical sciences
Expected recruitment start date
2010-05-25, 1389/03/04
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of long acting testosterone ampule in Patients with androgen deficiency syndrome presented at urology clinics of Ahwaz.
Public title
Effect of testosterone on androgen deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:Symptoms of androgen deficiency;Below normal rang of testosterone;age over 40 years
exclusion criteria:
Age
From 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Ahwaz JundiShapur University of medical sciences
Street address
Department of Research & Technology, Ahwaz JundiShapur University of medical sciences, Golestan Boulevard., Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
61357-15794
Approval date
2011-01-08, 1389/10/18
Ethics committee reference number
Eth-061
Health conditions studied
1
Description of health condition studied
Androgen deficiency syndrome
ICD-10 code
E29.1
ICD-10 code description
Testicular hypogonadism NOS
Primary outcomes
1
Description
Erectile dysfunction, Sex Frequency
Timepoint
Baseline , 2 months after the first injection
Method of measurement
International Index of Erectile Function Questionnaire
2
Description
Fasting Blood Sugar -2hour post prandial- HemoglobinA1c
Timepoint
Baseline , 2 months after the first injection
Method of measurement
FBS(mg/dl), 2hPP(mg/dl), HbA1C(%)
3
Description
Cholesterol, Triglyceride , High Density Lipoprotein, Low Density Lipoprotein
Timepoint
Baseline , 2 months after the first injection
Method of measurement
mg/dl
4
Description
Blood pressure
Timepoint
Baseline , 2 months after the first injection
Method of measurement
mmhg
Secondary outcomes
1
Description
Lower urinary tract symptom
Timepoint
Baseline , 2 months after the first injection
Method of measurement
International Prostate Symptom Score
2
Description
Depression, Sleep disorders, Fatigue
Timepoint
Baseline , 2 months after the first injection
Method of measurement
BECK QUESTIONNAIR
Intervention groups
1
Description
Control group: three intramusculare injection of Enanthate testosterone 250MG with three-week intervals
Category
Treatment - Drugs
2
Description
Intervention group: four intramuscular injection of Enanthate testosterone 250 mg with two-week intervals
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
abdolhosein javadneia
Street address
Department of Urology, Golestan hospital, Ahwaz JundiShapur University of medical sciences, Golestan Boulevard., Ahwaz, Khuzestan, Iran
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Research & Technology, Ahwaz JundiShapur University of medical sciences
Full name of responsible person
DR.MOSTAFA FEGHHI
Street address
Department of Research & Technology, Ahwaz JundiShapur University of medical sciences, Golestan Boulevard, Ahwaz, Khuzestan, Iran
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Research & Technology, Ahwaz JundiShapur University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz JundiShapur University of medical sciences
Full name of responsible person
Naser Abaszade, MD
Position
resident of Urology
Other areas of specialty/work
Street address
Department of Urology, Golestan hospital, Ahwaz JundiShapur University of medical sciences, Golestan Boulevard., Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
Phone
+98 46 1233 7926
Fax
Email
avrinabaszade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz JundiShapur University of medical sciences
Full name of responsible person
abdolhosein javadneia
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Urology, Golestan hospital, Ahwaz JundiShapur University of medical sciences, Golestan Boulevard., Ahwaz, Khuzestan, Iran
City
Ahwaz
Postal code
Phone
+98 61 1221 1335
Fax
+98 61 1374 3033
Email
javadneia_a@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz JundiShapur University of medical sciences
Full name of responsible person
abdolhosein javadneia
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Urology, Golestan hospital, Ahwaz JundiShapur University of medical sciences, Golestan Boulevard, Ahwaz, Khuzestan, Iran
City
ahwaz
Postal code
61357-15794
Phone
+98 61 1221 1335
Fax
+98 61 1374 3033
Email
javadneia_a@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)