Prostate CancerPhase 2ERECTNCT00737893

Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy

A Phase 2 study testing Erythropoietin (EPO) in people with Prostate Cancer and Erectile Dysfunction, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer. Read more about this study

Who is it for?: Ages 40 to 65 years, men only
Conditions the study is for: Prostate Cancer, Erectile Dysfunction
What is being tested?: Erythropoietin (EPO)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2017to 31 Dec 2019
Phase: Phase 2
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 40 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient eligibility consists of men 40 to 65 years of age
Localized prostate cancer
clinical stage T2a or lower
Gleason grade of 3+4 or 3+3
prostate specific antigen (PSA) < 10
Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function

Show all 10Show fewer

International Index of Erectile Function-5 (IIEF-5) score of 22-25.
The patient has a sexual partner, of at least 6 months.
The patient's pre-surgical hematocrit is ≤ 48.
The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.

Who cannot join

The patient has known penile deformity or a history of Peyronie's disease.
The patient has planned pre or post operative androgen therapy.
The patient has planned pre or post operative radiation therapy.
The patient is on anticoagulation therapy.
The patient has a history of sickle cell anemia.
The patient has a history of high or low blood pressure that is not controlled.

Show all 16Show fewer

The patient is taking medications called "nitrates"
The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
The patient has a history of history of drug or alcohol abuse.
The patient currently smokes or has a 20 pack/year history of cigarette smoking.
The patient has a history of acute or chronic depression
The patient has a history liver problems, or kidney problems.
The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.
The patient has a history of spinal trauma or surgery to the brain or spinal cord.
The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.
Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Hospital
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)

Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function.

Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.

Read the detailed description

This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical prostatectomy for prostate cancer.

Recent laboratory findings in rat models and on human urogenital tissues suggest that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively in a prospective, randomized study. Erythropoietin has been used in many men undergoing open radical prostatectomy in the past according to FDA indications for preparation for noncardiac, nonvascular surgery with a high risk of blood loss. Evidence also suggests it is safe with no demonstration of increased risk of venous thromboembolism (blood clots) or cardiac events for men with prostate cancer undergoing radical prostatectomy.

The length of the study is 12 months and involves receiving a dose of study drug or placebo on the day before surgery, the day of surgery, and the day following surgery. The dose is given by subcutaneous injection. The study will also require the completion of questionnaires which will be completed online every three months until study completion (at 3, 6, 9, and 12 months) to assess outcomes.

Conditions: Prostate Cancer, Erectile Dysfunction
Being tested: Placebo, Erythropoietin (EPO)
Keywords: Erythropoietin, Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer
Medical subject headings: Prostatic Neoplasms, Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Erythropoietin (EPO)Drug
Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

Study groups in NCT00737893
Study group	Role	What they receive
Erythropoietin (EPO)	Experimental	20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery. Receives: Drug: Erythropoietin (EPO)
Placebo	Placebo comparator	Placebo doses given the day before surgery, the day of surgery, and the day after surgery. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Measured: At 6 months post-surgery

Secondary outcomes (21)

Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Measured: At 3 months post-surgery
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Measured: At 9 months post-surgery
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.
Measured: At 12 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Measured: At 3 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Measured: At 6 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Measured: At 9 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function.
Measured: At 12 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Measured: At 3 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Measured: At 6 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Measured: At 9 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health.
Measured: At 12 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Measured: At 3 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Measured: At 6 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Measured: At 9 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100.
Measured: At 12 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Measured: At 3 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Measured: At 6 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Measured: At 9 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality.
Measured: At 12 months post-surgery
Hemoglobin Level at 2 Weeks After Surgery
Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl).
Measured: 2 weeks after surgery
Number of Participants Requiring Transfusion During Hospitalization
Assess the number of participants requiring transfusion during hospitalization.
Measured: During hospital stay, up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201731 Dec 2019

First posted20 Aug 2008 (estimated)
Study start1 Jul 2017
Primary completion31 Dec 2019
Study completion31 Dec 2019

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 (5)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
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: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00737893
Sponsor's protocol ID: IRB00048594
Other IDs: ERECT, EPO
Acronym: ERECT
Status last verified: Jul 2020
First submitted: 19 Aug 2008
Last updated: 8 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Patel HD, Allaf ME. Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: The ERECT Trial. Eur Urol Focus. 2019 Jul;5(4):698-699. doi: 10.1016/j.euf.2018.01.002. Epub 2018 Jan 17.
PubMed 29373284
Allaf ME, Hoke A, Burnett AL. Erythropoietin promotes the recovery of erectile function following cavernous nerve injury. J Urol. 2005 Nov;174(5):2060-4. doi: 10.1097/01.ju.0000176808.94610.dd.
PubMed 16217394
Liu T, Allaf ME, Lagoda G, Burnett AL. Erythropoietin receptor expression in the human urogenital tract: immunolocalization in the prostate, neurovascular bundle and penis. BJU Int. 2007 Nov;100(5):1103-6. doi: 10.1111/j.1464-410X.2007.07194.x. Epub 2007 Sep 14.
PubMed 17868418
Burnett AL, Allaf ME, Bivalacqua TJ. Erythropoietin promotes erection recovery after nerve-sparing radical retropubic prostatectomy: a retrospective analysis. J Sex Med. 2008 Oct;5(10):2392-8. doi: 10.1111/j.1743-6109.2008.00980.x. Epub 2008 Sep 5.
PubMed 18778310
Patel HD, Schwen ZR, Campbell JD, Gorin MA, Partin AW, Burnett AL, Allaf ME. Effect of Erythropoietin on Erectile Function after Radical Prostatectomy: The ERECT Randomized Clinical Trial. J Urol. 2021 Jun;205(6):1681-1688. doi: 10.1097/JU.0000000000001586. Epub 2021 Feb 3.
PubMed 33530745

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)
ClinicalTrials.gov ID: NCT00737893
Acronym / sponsor ID: ERECT / IRB00048594
Conditions: Prostate Cancer, Erectile Dysfunction
Keywords: Erythropoietin, Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 20 Aug 2008 (estimated)
Results: Posted 13 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Erythropoietin (EPO)	Experimental	Drug: Erythropoietin (EPO)20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.
Placebo	Placebo comparator	Drug: PlaceboPlacebo doses given the day before surgery, the day of surgery, and the day after surgery.

Who may qualify

Ages: 40 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patient eligibility consists of men 40 to 65 years of age
Localized prostate cancer
Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
International Index of Erectile Function-5 (IIEF-5) score of 22-25.
The patient has a sexual partner, of at least 6 months.

Key exclusion criteria (16 listed)

The patient has known penile deformity or a history of Peyronie's disease.
The patient has planned pre or post operative androgen therapy.
The patient has planned pre or post operative radiation therapy.
The patient is on anticoagulation therapy.
The patient has a history of sickle cell anemia.

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
PlaceboSaline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.	Drug	Placebo
Erythropoietin (EPO)Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.	Drug	Erythropoietin (EPO)

Primary outcome

Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Time frame: At 6 months post-surgery
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function.

21 secondary outcomes

Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Time frame: At 3 months post-surgery
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Time frame: At 9 months post-surgery
Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain
Time frame: At 12 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Time frame: At 3 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Time frame: At 6 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Time frame: At 9 months post-surgery
Patient Score on the Overall IIEF Questionnaire
Time frame: At 12 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Time frame: At 3 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Time frame: At 6 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Time frame: At 9 months post-surgery
Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS)
Time frame: At 12 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Time frame: At 3 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Time frame: At 6 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Time frame: At 9 months post-surgery
Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain
Time frame: At 12 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Time frame: At 3 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Time frame: At 6 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Time frame: At 9 months post-surgery
Patient Score on the Quality of Erection Questionnaire (QEQ)
Time frame: At 12 months post-surgery
Hemoglobin Level at 2 Weeks After Surgery
Time frame: 2 weeks after surgery
Number of Participants Requiring Transfusion During Hospitalization
Time frame: During hospital stay, up to 1 week

Results and safety

Results posted to the registry on 13 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erythropoietin (EPO)	29	29
Placebo	27	27

Primary outcome: Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain

Time frame: At 6 months post-surgery. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Erythropoietin (EPO) n = 29	Placebo n = 27
Value	14 (6.5 to 24)	19 (8 to 23)

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erythropoietin (EPO)	1 of 29 (3.4%)	0 of 29 (0%)	0 of 29
Placebo	1 of 27 (3.7%)	3 of 27 (11.1%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29373284Patel HD, Allaf ME. Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: The ERECT Trial. Eur Urol Focus. 2019 Jul;5(4):698-699. doi: 10.1016/j.euf.2018.01.002. Epub 2018 Jan 17.
Background: PubMed 16217394Allaf ME, Hoke A, Burnett AL. Erythropoietin promotes the recovery of erectile function following cavernous nerve injury. J Urol. 2005 Nov;174(5):2060-4. doi: 10.1097/01.ju.0000176808.94610.dd.
Background: PubMed 17868418Liu T, Allaf ME, Lagoda G, Burnett AL. Erythropoietin receptor expression in the human urogenital tract: immunolocalization in the prostate, neurovascular bundle and penis. BJU Int. 2007 Nov;100(5):1103-6. doi: 10.1111/j.1464-410X.2007.07194.x. Epub 2007 Sep 14.
Background: PubMed 18778310Burnett AL, Allaf ME, Bivalacqua TJ. Erythropoietin promotes erection recovery after nerve-sparing radical retropubic prostatectomy: a retrospective analysis. J Sex Med. 2008 Oct;5(10):2392-8. doi: 10.1111/j.1743-6109.2008.00980.x. Epub 2008 Sep 5.
Results publication: PubMed 33530745Patel HD, Schwen ZR, Campbell JD, Gorin MA, Partin AW, Burnett AL, Allaf ME. Effect of Erythropoietin on Erectile Function after Radical Prostatectomy: The ERECT Randomized Clinical Trial. J Urol. 2021 Jun;205(6):1681-1688. doi: 10.1097/JU.0000000000001586. Epub 2021 Feb 3.
The preoperative use of erythropoietin stimulating proteins prior to radical prostatectomy is not associated with increased cardiovascular or thromboembolic morbidity or mortality.Link provided by the sponsor.
Preoperative recombinant human erythropoietin injection versus preoperative autologous blood donation in patients undergoing radical retropubic prostatectomy.Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Mohamad E Allaf, MD principal investigator

Johns Hopkins Hospital - Brady Urological Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erythropoietin (EPO) in people with Prostate Cancer and Erectile Dysfunction, run by Johns Hopkins University 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 10 inclusion and 16 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: finished, as of the sponsor's last update on 8 Apr 2021. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Aug 2020). 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?

Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain (time frame: At 6 months post-surgery). 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 NCT00737893, which also lists 5 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 8 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.