Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

NCT01054001

Last updated date
Study Location
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 463-707, Korea, Republic of
Contact
82-31-787-7349

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

82-31-787-7349

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with agree to participate with the study

- Korean male subjects aged 50 years or older with clinically localized prostate cancer

- Preoperative potent men (IIEF-5 score 17 or more than 17)

- Patients in a stable, heterosexual relationship with a single partner for at least the past six months

- Suitable for nerve sparing indication

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Genital anatomical deformities that would significantly impair erection


- Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the
primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.


- Known raised prolactin level (>3 times the upper limit of the normal range) or low
free testosterone level (confirmed to be >20% below the lower limit of the normal
range on blood collected between 09:00 and 11:00 hours).


- Major psychiatric disorder (including major depression or schizophrenia) that is not
well controlled on treatment.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Prostate CancerA Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer
NCT00218205
  1. East Orange, New Jersey
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerMultimodality Phase II Study in Prostate Cancer
NCT00734851
  1. Baltimore, Maryland
  2. New Brunswick, New Jersey
  3. Durham, North Carolina
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerStudy on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
NCT02918968
  1. Nagoya, Aichi
  2. Nagoya, Aichi
  3. Matsuyama, Ehime
  4. Iizuka, Fukuoka
  5. Isesaki, Gunma
  6. Maebashi, Gunma
  7. Ota, Gunma
  8. Hakodate, Hokkaido
  9. Sapporo, Hokkaido
  10. Sapporo, Hokkaido
  11. Sapporo, Hokkaido
  12. Mito, Ibaraki
  13. Sagamihara, Kanagawa
  14. Yokohama, Kanagawa
  15. Yokohama, Kanagawa
  16. Yokosuka, Kanagawa
  17. Kashihara, Nara
  18. Kurashiki, Okayama
  19. Hirakata, Osaka
  20. Osakasayama, Osaka
  21. Suita, Osaka
  22. Kitaadachi-gun, Saitama
  23. Hamamatsu, Shizuoka
  24. Utsunomiya, Tochigi
  25. Bunkyo-ku, Tokyo
  26. Bunkyo-ku, Tokyo
  27. Koto-ku, Tokyo
  28. Nakano-ku, Tokyo
  29. Shinagawa-ku, Tokyo
  30. Shinjuku-ku, Tokyo
  31. Ube, Yamaguchi
  32. Chiba,
  33. Chiba,
  34. Fukuoka,
  35. Fukuoka,
  36. Fukuoka,
  37. Hiroshima,
  38. Kyoto,
  39. Nagano,
  40. Nagano,
  41. Nagasaki,
  42. Osaka,
  43. Osaka,
  44. Osaka,
  45. Saga,
  46. Tokushima,
  47. Toyama,
Male
20 Years+
years
MULTIPLE SITES
Prostate CancerPalbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT02905318
  1. Edmonton, Alberta
  2. Vancouver, British Columbia
  3. Halifax, Nova Scotia
  4. Hamilton, Ontario
  5. London, Ontario
  6. Ottawa, Ontario
  7. Toronto, Ontario
  8. Montreal, Quebec
  9. Montreal, Quebec
  10. Regina, Saskatchewan
  11. Saskatoon, Saskatchewan
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
Official Title  ICMJE Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy
Brief Summary The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).
Detailed Description

Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in men received NSRP, and improvements of the potency rate did not appear to be statistically different among two dosing regimens.

But, there are few studies on the potency rate according to the start time of the administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At present, it is not conclusive that whether nerve-sparing RALP provides more higher potency rate than conventional surgery in men with prostate cancers. But, with more precise dissection of CN, the robotic surgery appears to have more chances to maintain the potency in men received RP.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: sildenafil 100mg
sildenafil 100mg per oral twice a week
Other Name: Viagra 100mg
Study Arms  ICMJE
  • Active Comparator: Early
    men with on- demand sildenafil 100mg dosing from the early postoperative period
    Intervention: Drug: sildenafil 100mg
  • Active Comparator: Delayed
    men with on- demand sildenafil 100mg dosing from the delayed postoperative period
    Intervention: Drug: sildenafil 100mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 21, 2010)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with agree to participate with the study
  • Korean male subjects aged 50 years or older with clinically localized prostate cancer
  • Preoperative potent men (IIEF-5 score 17 or more than 17)
  • Patients in a stable, heterosexual relationship with a single partner for at least the past six months
  • Suitable for nerve sparing indication

Exclusion Criteria:

  • Genital anatomical deformities that would significantly impair erection
  • Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.
  • Known raised prolactin level (>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be >20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours).
  • Major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054001
Other Study ID Numbers  ICMJE WS486539
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Eun Lee, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Sang Eun Lee, ProfessorSeoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP