Testosterone for Penile Rehabilitation After Radical Prostatectomy

Mohit Khera

Status and phase: Terminated; Early Phase 1

Conditions: Erectile Dysfunction; Hypogonadism

Treatments: Other: Placebo Testim®; Drug: Testim®; Drug: Viagra®

Study type: Interventional

Funder types: Other

Identifiers

NCT00848497

H-21148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups, including a placebo group

Testim® + Viagra®

Active Comparator group

Description:

Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night

Treatment:

Drug: Viagra®

Drug: Testim®

Placebo Testim® + Viagra®

Placebo Comparator group

Description:

Placebo Testim® gel once daily + Viagra® 25 mg tablet every night

Treatment:

Drug: Viagra®

Other: Placebo Testim®