NCT02248467|Completed
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Sponsor study identifier
observational
100
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
Actual (reported)Study Completion
June 2018
Actual (reported)The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible for bariatric surgery, the effect of testosterone replacement therapy in improving lower urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score) questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 17, 2014
Actual (reported)September 25, 2014
Actual (reported)December 2017
Actual (reported)June 2018
Actual (reported)IPSS score (LUTS) improvement
For each patient the presence of an improvement of LUTS, assessed by IPSS score, will be evaluated by calculating the difference between the scores of the IPSS questionnaire administered at V1 compared to that administered to V0, V2 as compared to V1, or V3 as compared to V2. The mean of this change will be then compared between different groups (eugonadal; untreated hypogonadal; treated hypogonadal)
1 yr after surgery
Presence of Metabolic Syndrome
1 yr after surgery
Volumetric change of the prostate
1 yr after surgery
Change in the number of prostatic macrocalcifications
1 yr after surgery
Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate
1 yr after surgery
Improvement of sexual function
1 yr after surgery
50 eugonadal subjects
25 asymptomatic hypogonadal subjects
25 symptomatic hypogonadal subjects treated - In the present study, we decided to monitor only sexual symptoms of androgen deficiency due to the fact that testosterone replacement therapy (TRT) should be expected to improve them in the time span until surgery. These patients will be treated with TRT as per clinical practice.
Male adults subjects suffering from severe obesity in a waiting list for bariatric surgery for weight loss will be considered eligible. The diagnosis of hypogonadism will be defined by levels of total testosterone \<12nmol / l or free testosterone \<225 pmol / L (calculated according to the formula of Vermeulen).
Ambulatori Medicina della Sessualità e Andrologia
Florence, Italy
Lotti F, Corona G, Colpi GM, Filimberti E, Degli Innocenti S, Mancini M, Baldi E, Noci I, Forti G, Adorini L, Maggi M. Elevated body mass index correlates with higher seminal plasma interleukin 8 levels and ultrasonographic abnormalities of the prostate in men attending an andrology clinic for infertility. J Endocrinol Invest. 2011 Nov;34(10):e336-42. doi: 10.3275/7855. Epub 2011 Jul 7.
Filippi S, Vignozzi L, Morelli A, Chavalmane AK, Sarchielli E, Fibbi B, Saad F, Sandner P, Ruggiano P, Vannelli GB, Mannucci E, Maggi M. Testosterone partially ameliorates metabolic profile and erectile responsiveness to PDE5 inhibitors in an animal model of male metabolic syndrome. J Sex Med. 2009 Dec;6(12):3274-88. doi: 10.1111/j.1743-6109.2009.01467.x. Epub 2009 Sep 1.
Mario Maggi
University of Florence
100 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2014
First Posted
September 25, 2014
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity
Contact the study team to confirm eligibility.
Vignozzi L, Morelli A, Sarchielli E, Comeglio P, Filippi S, Cellai I, Maneschi E, Serni S, Gacci M, Carini M, Piccinni MP, Saad F, Adorini L, Vannelli GB, Maggi M. Testosterone protects from metabolic syndrome-associated prostate inflammation: an experimental study in rabbit. J Endocrinol. 2012 Jan;212(1):71-84. doi: 10.1530/JOE-11-0289. Epub 2011 Oct 18.
Maseroli E, Comeglio P, Corno C, Cellai I, Filippi S, Mello T, Galli A, Rapizzi E, Presenti L, Truglia MC, Lotti F, Facchiano E, Beltrame B, Lucchese M, Saad F, Rastrelli G, Maggi M, Vignozzi L. Testosterone treatment is associated with reduced adipose tissue dysfunction and nonalcoholic fatty liver disease in obese hypogonadal men. J Endocrinol Invest. 2021 Apr;44(4):819-842. doi: 10.1007/s40618-020-01381-8. Epub 2020 Aug 8.
Primary Completion
December 2017
Actual (reported)Study Completion
June 2018
Actual (reported)Last Updated
October 12, 2018
Record last verified: 2018-10
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