Testosterone for Penile Rehabilitation After Radical Prostatectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy

NCT04833426

Prostatic Neoplasms Hypogonadism Testosterone Deficiency

RECRUITING PHASE3

Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

NCT03716739

Prostate Cancer

COMPLETED PHASE2

Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer

NCT00853697

Prostate Cancer Castration-resistant, Metastatic

COMPLETED PHASE2

Testosterone Replacement in Renal Failure

NCT02712944

Hypogonadism

TERMINATED PHASE1

Natesto Testosterone Nasal Gel for Hypogonadal Men

NCT05484167

Erectile Dysfunction Sexual Dysfunction

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypogonadism Erectile Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Testim® + Viagra®

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

Group Type ACTIVE_COMPARATOR

Testim®

Intervention Type DRUG

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.

Viagra®

Intervention Type DRUG

Viagra 25mg was the dose given to the patient which he started.

Placebo Testim® + Viagra®

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

Group Type PLACEBO_COMPARATOR

Placebo Testim®

Intervention Type OTHER

Placebo Testim® 5 g of gel (one tube)

Viagra®

Intervention Type DRUG

Viagra 25mg was the dose given to the patient which he started.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Placebo Testim®

Placebo Testim® 5 g of gel (one tube)

Intervention Type OTHER

Viagra®

Viagra 25mg was the dose given to the patient which he started.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Testim® is the brand name for testosterone gel. Placebo Testim Viagra® is the brand name for sildenafil citrate. Viagra® 25 mg tablet daily at night

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No