Testosterone for Penile Rehabilitation After Radical Prostatectomy

This study has been terminated.
(Lack of volunteers who would consent to participate and lack of funding)
Sponsor:
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00848497
First received: February 19, 2009
Last updated: June 2, 2015
Last verified: June 2015
  Purpose

The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.

Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.


Condition Intervention Phase
Hypogonadism
Erectile Dysfunction
Drug: Testim®
Other: Placebo Testim®
Drug: Viagra®
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED


Secondary Outcome Measures:
  • Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function

  • Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    ADAM scores of one evaluated patient. ADAM is 10 questions ("yes" or "no" answers) and if you answer yes to question 1 or 7 or "yes" to any 3 questions you are said to test "positive" to the ADAM questionnaire.

  • Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit. [ Time Frame: Basline and 6 months ] [ Designated as safety issue: No ]
    EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better


Enrollment: 3
Study Start Date: November 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testim® + Viagra®
Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Drug: Testim®
Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily. This was the dose given to the patient which he started.
Other Name: Testim® is the brand name for testosterone gel.
Drug: Viagra®
Viagra 25mg was the dose given to the patient which he started.
Other Names:
  • Viagra® is the brand name for sildenafil citrate.
  • Viagra® 25 mg tablet daily at night
Placebo Comparator: Placebo Testim® + Viagra®
Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
Other: Placebo Testim®
Placebo Testim® 5 g of gel (one tube)
Other Name: Placebo Testim
Drug: Viagra®
Viagra 25mg was the dose given to the patient which he started.
Other Names:
  • Viagra® is the brand name for sildenafil citrate.
  • Viagra® 25 mg tablet daily at night

Detailed Description:

There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males, 18 years of age or older, with low testosterone levels.
  • Must have undergone a bilateral nerve sparing radical prostatectomy.
  • Nadir PSA (Prostate-Specific Antigen) values should be less than 0.01 ng/ml on two consecutive occasions separated by 4 weeks at the start of treatment.
  • Must give informed consent.
  • Must be willing to complete follow-up visits.

Exclusion Criteria:

  • Testosterone level greater than 300 ng/ dl
  • Hemoglobin level greater than 18 ng/dl.
  • Positive surgical margins or evidence of residual prostate cancer after surgery.
  • Clinically suspected advanced disease or actual evidence of metastatic prostate cancer.
  • Primary Gleason Grade greater than 3 or secondary Gleason Grade greater than 4 in the final pathologic specimen will be excluded.
  • Taking nitrates or with contraindications to the use of Viagra or androgen therapy will be excluded.
  • Known hypersensitivity to any component of the tablet will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848497

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mohit Khera
Investigators
Principal Investigator: Mohit Khera, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Mohit Khera, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00848497     History of Changes
Other Study ID Numbers: H-21148
Study First Received: February 19, 2009
Results First Received: March 18, 2013
Last Updated: June 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
hormone replacement therapy
radical prostatectomy
erectile dysfunctions
scheduled for removal of prostate gland

Additional relevant MeSH terms:
Erectile Dysfunction
Hypogonadism
Endocrine System Diseases
Genital Diseases, Male
Gonadal Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Methyltestosterone
Sildenafil
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on September 03, 2015