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02 September 2010
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| [ Print-friendly version ] |
| Treatment of Peyronie's disease with hyperthermia, vitamin D and testosterone: a pilot randomised controlled trial |
| ISRCTN | ISRCTN82950322 |
| ClinicalTrials.gov identifier | |
| Public title | Treatment of Peyronie's disease with hyperthermia, vitamin D and testosterone: a pilot randomised controlled trial |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
To evaluate the effectiveness and safety of the combination of hyperthermia, vitamin D and testosterone in the treatment of Peyronie's disease compared with hyperthermia alone.
As of 25/02/2010 this record was updated to reflect a change to the study design of this trial. This is now a pilot randomised controlled trial instead of a randomised controlled trial. At this time, the anticipated trial dates were also updated; the previous anticipated trial dates were as follows: Initial anticipated start date: 26/09/2007 Initial anticipated end date: 26/03/2010 Also, the target number of participants has been amended from 60 participants to 20 participants. |
| Ethics approval | Ethics approval received from the ethics committee of Hospital de Clinicas da Universidade Federal do Parana (Brazil) on the 19th September 2007 (ref: CAAE: 01730208000-07; CEP/HC: 1489.154/2007-07). |
| Study design | Pilot randomised controlled trial |
| Countries of recruitment | Brazil |
| Disease/condition/study domain | Peyronie's disease |
| Participants - inclusion criteria | Patients with Peyronie's disease. |
| Participants - exclusion criteria |
1. Prostate cancer
2. Hyperprolactinaemia 3. Congestive heart failure 4. Severe dyslipidemia 5. Severe hypertension |
| Anticipated start date | 01/04/2010 |
| Anticipated end date | 01/04/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 20 patients |
| Interventions |
Please note that as of 06/02/2008 the anticipated end date of this trial was extended to 26/03/2010. The previous anticipated end date was 26/09/2008.
Current interventions as of 25/02/2010: The interventions will take place with a duration of 16 weeks. At baseline, all patients will be analysed clinically and with lab exams: 1. Total and free testosterone 2. Prostate specific antigen (PSA) 3. Haemogram 4. Prolactin 5. Luteinising hormone (LH) 6. Digital rectal examination 7. Ultrasonography of penis and photos of penis during erection Patients will be randomised to: 1. Control group:10 patients will be treated with hyperthermia alone during 30 minutes/day with infrared laser applied directly over the plaque and curvature for 16 weeks. 2. Experimental group: 10 patients will be treated with hyperthermia (as above) plus Vitamin D 30.000 UI/day/oral and an injection of testosterone depot (Durateston®) every 10 days initially (patients with baseline levels of free testosterone under upper normal levels) All patients will have to return every month and levels of testosterone and vitamin D will be analysed (patients of the experimental group) to reach the goal of upper normal levels of free testosterone and maximum non-toxic normal level of vitamin D. At the end of 16 weeks, patients of the experimental group will have their levels of PSA and haemogram analysed as well as digital rectal examination. Both groups at the end of 16 weeks will have ultrasonography of penis and will take photos of their penis during erection. Initial information at time of registration: The interventions will take place over a duration of one year. At baseline, all patients will be analysed clinically and with lab exams: 1. Total and free testosterone 2. Prostate Specific Antigen (PSA) 3. Haemogram 4. Prolactin 5. Luteinising Hormone (LH) 6. Digital rectal examination 7. Ultrasonography of penis and photos of penis during erection Patients will be randomised to: 1. Control group: 30 patients will be treated with hyperthermia alone (30 minutes/day with infrared lamp of 150 W at a distance of approximately 20 cm of the plaque(s) and curvature) 2. Experimental group: 30 patients will be treated with hyperthermia (as above) plus Vitamin D (4000 IU/day/oral) and one injection of Testosterone depot (Durateston®) every 2 weeks initially (patients with baseline levels of free testosterone under median normal level) All patients will have to return every month and levels of testosterone and vitamin D will be analysed to reach the goal of median normal level of free testosterone and maximum normal level of vitamin D. Every 3 months, levels of PSA and Haemogram will be analysed and at 6 months and 1 year digital rectal examination and also ultrasonography and photos of penis on erection will be analysed. |
| Primary outcome measure(s) |
1. Decreased size of plaques, measured every month throughout the duration of the trial
2. Decreased curvature of penis, measured every month throughout the duration of the trial |
| Secondary outcome measure(s) |
1. Improvement of sexual function, measured every month throughout the duration of the trial
2. Improvement of self-esteem, measured every month throughout the duration of the trial |
| Sources of funding | Investigator initiated and funded trial (Brazil) |
| Trial website | |
| Publications | |
| Contact name | Dr Carlos Cesar Cusmanich |
| Address | Rua Oyapock , 67 Apart 101 |
| City/town | Curitiba (State of Parana) |
| Zip/Postcode | 80050-450 |
| Country | Brazil |
| Tel | +55 41 9976 4500 |
| Fax | +55 41 3263 4294 |
| cesarcus@onda.com.br | |
| Sponsor | Hospital de Clinicas da Universidade Federal do Paraná (UFPR) (Brazil) |
| Address |
c/o Miss Simone
Rua General Carneiro, 181 |
| City/town | Curitiba (State of Parana) |
| Zip/Postcode | 80060-900 |
| Country | Brazil |
| Sponsor website: | http://www.hc.ufpr.br/ |
| Date applied | 29/09/2007 |
| Last edited | 25/02/2010 |
| Date ISRCTN assigned | 30/10/2007 |
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| © 2010 ISRCTN unless otherwise stated. | |
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