Male Erectile DisorderPhase 2NCT01105130
L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors
A Phase 2 study testing Oral L-Arginine in people with Male Erectile Disorder and Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: L-arginine supplements may improve the quality of life and erectile function in men who are prostate cancer survivors. PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works with or without enzyme inhibitors in treating erectile function and quality of life of prostate… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Erectile Disorder, Prostate Cancer, Radiation Toxicity
- What is being tested?
- Oral L-Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2010to 4 Feb 2014
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male prostate cancer survivor previously treated with radiotherapy and who identifies himself as concerned with sexual quality of life, including erectile dysfunction. (seed implants are eligible)
- Had successful sexual activity prior to the commencement of radiotherapy.
- Erectile dysfunction, defined as inability to achieve or maintain an erection sufficient for satisfactory sexual performance
- Interested in sexual activity and agrees to make at least one sexual intercourse attempt with a partner every week during the study.
- The usage of PDE-5 inhibitors will be voluntary and will serve as a stratification factor. Patients taking PDE-5 inhibitors must agree to assume the responsibility for the cost of PDE-5 inhibitor treatment during the protocol period (8 week period) as this is not covered in the cost of the trial.
- Patients currently taking PDE-5 inhibitors sildenafil (Viagra®, Pfizer Pharmaceuticals), tadalafil(Cialis®, Lilly ICOS, LLC), and vardenafil (Levitra®, Bayer Healthcare / Schering Plough Corp.)must agree to take the medication only as prescribed by their treating physician.
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- Patients taking PDE-5 inhibitors as part of this study must be on a stable dose of drug for at least one month prior to study entry.
- Must be able to take oral medications.
- > 6 months following completion of all cancer therapy
- No evidence of prostate cancer
- Prior malignancies allowed if no evidence of recurrent disease.
- If previously taken LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents, serum testosterone must have returned to the laboratory normal range
- No planned surgery while on protocol or for 4 weeks following completion of protocol
- Prior cystoscopy is permitted.
- Age > 18
- ECOG performance status 0/1.
- Patients must agree not to start taking an herbal product for erectile dysfunction during the eight weeks of study intervention.
Who cannot join
- No other concurrent erectile dysfunction therapies permitted (i.e. vacuum pump,cavernosal injections, and other drug therapies). Past use of these and other therapies permitted if the patient can meet the inclusion criteria above.
- No testosterone supplementation permitted.
- Use of LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti- androgen (e.g., Casodex,Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months.
- Prior prostate or lower genitourinary surgery (bladder, penis, urethra, testicles)including transurethral resection of prostate (TURP). (Prior vasectomy is allowed)
- Serious cardiovascular disease (unstable angina, supraventricular arrhythmia, myocardial infarction, symptomatic congestive heart failure, cardiac arrhythmia, coronary artery bypass surgery within 6 months prior to registration).
- Hypotension (<90/50mm Hg), or uncontrolled hypertension (>170/100 mm Hg)
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- Stroke or spinal cord injury within 6 months before registration.
- Patients on Persantine, heparin, Lovenox, warfarin, ginkgo biloba, Plavix, Disalcid, other blood-thinning medication or with a history of bleeding disorders will be excluded.(Aspirin < 325mg allowed)
- Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up.
- Current or prior use of any organic nitrate within the last 6 months (e.g., use of nitroglycerin)
- May not receive other investigational agents or devices during 30 days prior to start of study drug.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax (l-arginine, ginseng, or ginkgo biloba)
Trial locations and contacts
1 site in 1 country.
United States1 site
W F Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Phase II Dose Finding Study of ArginMax for Its Effect on Erectile Function and Quality of Life in Survivors of Prostate Cancer Previously Treated With Radiotherapy
RATIONALE: L-arginine supplements may improve the quality of life and erectile function in men who are prostate cancer survivors.
PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works with or without enzyme inhibitors in treating erectile function and quality of life of prostate cancer survivors previously treated with radiation therapy.
Read the detailed description
OBJECTIVES:
Primary
- To determine the "best dose" (defined as the dose that shows the greatest improvement in the erectile function domain of the International Index of Erectile Function [IIEF] after 8 weeks of therapy) of an L-arginine/Korean ginseng/gingko biloba/damiana-based supplement (L-arginine) to be used in a subsequent phase III trial in prostate cancer survivors previously treated with radiotherapy.
Secondary
- Evaluate the toxicity of treatment with L-arginine with or without phosphodiesterase-5 inhibitors.
- Estimate trial accrual, retention, adherence, and variability.
- Assess changes in quality of life (QOL) and sexual function as defined by changes in the QOL of these patients using the Expanded Prostate Cancer Index Composite, changes in the other domains of the IIEF (i.e., orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), changes in the Sexual Encounter Profile, and changes in the percentage of "yes" (positive) responses to either of the two global efficacy questions.
OUTLINE: Patients are stratified according to age (< 65 years vs ≥ 65 years) and current use of phosphodiesterase-5 (PDE-5) inhibitors (yes vs no). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo twice daily (total of 6 capsules per day).
- Arm II: Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
- Arm III: Patients receive oral L-arginine twice daily (total of 6 capsules per day).
In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
Patients may also receive oral sildenafil, tadalafil, or vardenafil (PDE-5 inhibitors).
Patients complete the International Index of Erectile Function and the Expanded Prostate Cancer Index Composite-26 at baseline and at weeks 4 and 8. Patients also complete the Sexual Encounter Profile Questionnaire, FACT-P, and the Global Efficacy Questionnaire at weeks 4 and 8.
- Conditions
- Male Erectile Disorder, Prostate Cancer, Radiation Toxicity
- Being tested
- Placebo, Oral L-Arginine
- Keywords
- radiation toxicity, male erectile disorder, prostate cancer
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Given orally
Oral L-ArginineDrug
Also called ArginMax, Placebo
Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-ArginineDrug
Also called ArginMax
Patients will take 6 capsules of ArginMax twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm I - Placebo | Placebo comparator | Patients receive oral placebo twice daily (total of 6 capsules per day). Receives: Other: Placebo |
| Arm II - low dose | Experimental | Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). Receives: Other: Placebo; Drug: Oral L-Arginine |
| Arm III - high dose | Experimental | Oral L-arginine twice daily = 6 capsules per day. Receives: Drug: Oral L-Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF)
The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.
Measured: 8 weeks
Secondary outcomes (3)
Retention
Retention is the percentage of participants who complete the 8 week visit.
Measured: 8 weeks
Adherence
Adherence is the percentage of prescribed pills taken by the participants
Measured: 8 weeks
Assessment of Quality of Life
Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT_P) questionnaire. The FACT questionnaire is comprised of four subscales - social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study start1 Oct 2010
- Primary completion4 Feb 2014
- Study completion4 Feb 2014
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.
- Other trials for Male Erectile DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James J. Urbanic, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105130
- Sponsor's protocol ID
- IRB00012793
- Other IDs
- U10CA081851, REBACCCWFU 98110
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2010
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Dose Finding Study of ArginMax for Its Effect on Erectile Function and Quality of Life in Survivors of Prostate Cancer Previously Treated With Radiotherapy
- ClinicalTrials.gov ID
- NCT01105130
- Acronym / sponsor ID
- IRB00012793
- Conditions
- Male Erectile Disorder, Prostate Cancer, Radiation Toxicity
- Keywords
- radiation toxicity, male erectile disorder, prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 4 Feb 2014 (actual)
- Study completion
- 4 Feb 2014 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Posted 21 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: L-arginine supplements may improve the quality of life and erectile function in men who are prostate cancer survivors.
PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works with or without enzyme inhibitors in treating erectile function and quality of life of prostate cancer survivors previously treated with radiation therapy.
Detailed description
OBJECTIVES:
Primary
- To determine the "best dose" (defined as the dose that shows the greatest improvement in the erectile function domain of the International Index of Erectile Function [IIEF] after 8 weeks of therapy) of an L-arginine/Korean ginseng/gingko biloba/damiana-based supplement (L-arginine) to be used in a subsequent phase III trial in prostate cancer survivors previously treated with radiotherapy.
Secondary
- Evaluate the toxicity of treatment with L-arginine with or without phosphodiesterase-5 inhibitors.
- Estimate trial accrual, retention, adherence, and variability.
- Assess changes in quality of life (QOL) and sexual function as defined by changes in the QOL of these patients using the Expanded Prostate Cancer Index Composite, changes in the other domains of the IIEF (i.e., orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), changes in the Sexual Encounter Profile, and changes in the percentage of "yes" (positive) responses to either of the two global efficacy questions.
OUTLINE: Patients are stratified according to age (< 65 years vs ≥ 65 years) and current use of phosphodiesterase-5 (PDE-5) inhibitors (yes vs no). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo twice daily (total of 6 capsules per day).
- Arm II: Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
- Arm III: Patients receive oral L-arginine twice daily (total of 6 capsules per day).
In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
Patients may also receive oral sildenafil, tadalafil, or vardenafil (PDE-5 inhibitors).
Patients complete the International Index of Erectile Function and the Expanded Prostate Cancer Index Composite-26 at baseline and at weeks 4 and 8. Patients also complete the Sexual Encounter Profile Questionnaire, FACT-P, and the Global Efficacy Questionnaire at weeks 4 and 8.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I - Placebo | Placebo comparator | Other: PlaceboPatients receive oral placebo twice daily (total of 6 capsules per day). |
| Arm II - low dose | Experimental | Other: Placebo, Drug: Oral L-ArgininePatients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day). |
| Arm III - high dose | Experimental | Drug: Oral L-ArginineOral L-arginine twice daily = 6 capsules per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male prostate cancer survivor previously treated with radiotherapy and who identifies himself as concerned with sexual quality of life, including erectile dysfunction. (seed implants are eligible)
- Had successful sexual activity prior to the commencement of radiotherapy.
- Erectile dysfunction, defined as inability to achieve or maintain an erection sufficient for satisfactory sexual performance
- Interested in sexual activity and agrees to make at least one sexual intercourse attempt with a partner every week during the study.
- The usage of PDE-5 inhibitors will be voluntary and will serve as a stratification factor. Patients taking PDE-5 inhibitors must agree to assume the responsibility for the cost of PDE-5 inhibitor treatment during the protocol period (8 week period) as this is not covered in the cost of the trial.
Key exclusion criteria (12 listed)
- No other concurrent erectile dysfunction therapies permitted (i.e. vacuum pump,cavernosal injections, and other drug therapies). Past use of these and other therapies permitted if the patient can meet the inclusion criteria above.
- No testosterone supplementation permitted.
- Use of LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti- androgen (e.g., Casodex,Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months.
- Prior prostate or lower genitourinary surgery (bladder, penis, urethra, testicles)including transurethral resection of prostate (TURP). (Prior vasectomy is allowed)
- Serious cardiovascular disease (unstable angina, supraventricular arrhythmia, myocardial infarction, symptomatic congestive heart failure, cardiac arrhythmia, coronary artery bypass surgery within 6 months prior to registration).
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 |
|---|---|---|
| PlaceboGiven orally | Other | Arm I - Placebo, Arm II - low dose |
| Oral L-ArginineAlso: ArginMax, PlaceboGiven orally 3 capsules ArginMax and 3 Placebo capsules | Drug | Arm II - low dose, Arm III - high dose |
| Oral L-ArginineAlso: ArginMaxPatients will take 6 capsules of ArginMax twice daily | Drug | Arm III - high dose |
Primary outcome
International Index of Erectile Function (IIEF)
Time frame: 8 weeks
The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.
3 secondary outcomes
Retention
Time frame: 8 weeks
Adherence
Time frame: 8 weeks
Assessment of Quality of Life
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
James J. Urbanic, MD study chair
Wake Forest University Health Sciences
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 Oral L-Arginine in people with Male Erectile Disorder and Prostate Cancer, run by Wake Forest University Health Sciences 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 17 inclusion and 12 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 28 Sep 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 21 Jul 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?
International Index of Erectile Function (IIEF) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.