HypogonadismEarly Phase 1NCT00848497
Testosterone for Penile Rehabilitation After Radical Prostatectomy
A Early Phase 1 study testing Testim® and Viagra® in people with Hypogonadism and Erectile Dysfunction, run by Mohit Khera at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism, Erectile Dysfunction
- What is being tested?
- Testim® and Viagra®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
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.
Read the 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.
- Conditions
- Hypogonadism, Erectile Dysfunction
- Being tested
- Testim®, Placebo Testim®, Viagra®
- Keywords
- hormone replacement therapy, radical prostatectomy, erectile dysfunctions, scheduled for removal of prostate gland
- Medical subject headings
- Hypogonadism, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testim®Drug
Also called Testim® is the brand name for testosterone gel.
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.
Placebo Testim®Other
Also called Placebo Testim
Placebo Testim® 5 g of gel (one tube)
Viagra®Drug
Also called Viagra® is the brand name for sildenafil citrate., Viagra® 25 mg tablet daily at night
Viagra 25mg was the dose given to the patient which he started.
| Study group | Role | What they receive |
|---|---|---|
| Testim® + Viagra® | Active comparator | Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night Receives: Drug: Testim®; Drug: Viagra® |
| Placebo Testim® + Viagra® | Placebo comparator | Placebo Testim® gel once daily + Viagra® 25 mg tablet every night Receives: Other: Placebo Testim®; Drug: Viagra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
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
Measured: Baseline and 6 months
Secondary outcomes (3)
Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.
There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function
Measured: Baseline and 6 months
Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
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.
Measured: Baseline and 6 months
Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better
Measured: Basline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startNov 2007
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Lack of volunteers who would consent to participate and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohit Khera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohit Khera, Baylor College of Medicine
- Investigators
- Mohit Khera, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848497
- Sponsor's protocol ID
- H-21148
- Status last verified
- Jun 2015
- First submitted
- 19 Feb 2009
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Khera M, Grober ED, Najari B, Colen JS, Mohamed O, Lamb DJ, Lipshultz LI. Testosterone replacement therapy following radical prostatectomy. J Sex Med. 2009 Apr;6(4):1165-1170. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22.
PubMed 19207277Khera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. doi: 10.1016/j.ucl.2007.08.007.
PubMed 17983894Khera M. Androgens and erectile function: a case for early androgen use in postprostatectomy hypogonadal men. J Sex Med. 2009 Mar;6 Suppl 3:234-8. doi: 10.1111/j.1743-6109.2008.01159.x. Epub 2009 Jan 21.
PubMed 19207279
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
- ClinicalTrials.gov ID
- NCT00848497
- Acronym / sponsor ID
- H-21148
- Conditions
- Hypogonadism, Erectile Dysfunction
- Keywords
- hormone replacement therapy, radical prostatectomy, erectile dysfunctions, scheduled for removal of prostate gland
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of volunteers who would consent to participate and lack of funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mohit KheraUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testim® + Viagra® | Active comparator | Drug: Testim®, Drug: Viagra®Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night |
| Placebo Testim® + Viagra® | Placebo comparator | Other: Placebo Testim®, Drug: Viagra®Placebo Testim® gel once daily + Viagra® 25 mg tablet every night |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testim®Also: Testim® is the brand name for testosterone gel.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. | Drug | Testim® + Viagra® |
| Placebo Testim®Also: Placebo TestimPlacebo Testim® 5 g of gel (one tube) | Other | Placebo Testim® + Viagra® |
| Viagra®Also: Viagra® is the brand name for sildenafil citrate., Viagra® 25 mg tablet daily at nightViagra 25mg was the dose given to the patient which he started. | Drug | Placebo Testim® + Viagra®, Testim® + Viagra® |
Primary outcome
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
Time frame: Baseline and 6 months
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
3 secondary outcomes
Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.
Time frame: Baseline and 6 months
Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
Time frame: Baseline and 6 months
Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
Time frame: Basline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19207277Khera M, Grober ED, Najari B, Colen JS, Mohamed O, Lamb DJ, Lipshultz LI. Testosterone replacement therapy following radical prostatectomy. J Sex Med. 2009 Apr;6(4):1165-1170. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22.
- Background: PubMed 17983894Khera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. doi: 10.1016/j.ucl.2007.08.007.
- Background: PubMed 19207279Khera M. Androgens and erectile function: a case for early androgen use in postprostatectomy hypogonadal men. J Sex Med. 2009 Mar;6 Suppl 3:234-8. doi: 10.1111/j.1743-6109.2008.01159.x. Epub 2009 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Khera, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Testim® and Viagra® in people with Hypogonadism and Erectile Dysfunction, run by Mohit Khera at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848497, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.