Erectile DysfunctionPhase 2NCT01160289

A Study of LY900010 in Erectile Dysfunction

A Phase 2 study testing LY2452473 and tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 36 sites in United States.

Completed

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

Official record

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Trial summary

The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone. Read more about this study

Who is it for?: Ages 45 to 70 years, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: LY2452473 and tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 410 participants
Where: 36 sitesUnited States
Study dates: Oct 2010to Nov 2011
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 45 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Ambulatory men
History of erectile dysfunction of at least 3 months duration
History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label
Anticipate having the same female sexual partner throughout the duration of the study
Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study
Agree to use birth control during the study and for 60 days after the study, unless the female partner is postmenopausal

Show all 10Show fewer

Agree not to use any other erectile dysfunction treatment, including herbal treatment, during the study and for 96 hours after the last dose of study drug
Screening laboratory tests within normal limits except for testosterone
Without a language barrier, are reliable and willing to follow study procedures
Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative histological biopsy of carcinoma of prostate within 12 months prior to screening

Who cannot join

History of penile implant
History of no response to injection therapy for erectile dysfunction
History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection
Exhibit the presence of clinically significant penile deformity in the opinion of the investigator
History of prior sexual legal convictions
Bilateral hip replacements

Show all 24Show fewer

History of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin
Chronic stable angina currently treated with long-acting nitrates
Chronic stable angina requiring treatment with short-acting nitrates within 90 days prior to screening
Angina occurring during sexual intercourse in the 6 months prior to screening
Unstable angina within 6 months prior to screening
Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening
Angioplasty or stent placement within 90 days prior to screening
Congestive heart failure within 6 months prior to screening
History of sudden cardiac arrest
Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator
An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject in an unacceptable risk for study participation
Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening
Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active neuropsychiatric disease
History of central nervous system injuries (including stroke or spinal cord injury) within 6 months prior to screening
Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine, or 1.5 ounces of 80-proof distilled spirits)
Receiving treatment with antiandrogens or 5-alpha reductase inhibitor
Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000 international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal supplements, nutritional products intended to have weight reduction or performance enhancing effects, herbal supplements within 7 days prior to screening
Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aventura, Florida, 33180
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Bellevue, Washington, 98007
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Birmingham, Alabama, 35209
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Cary, North Carolina, 27511
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Celebration, Florida, 34747
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Charlotte, North Carolina, 28207
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Coeur d'Alene, Idaho, 83814
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Coral Springs, Florida, 33065
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Dallas, Texas, 75234
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Denver, Colorado, 80220
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Des Moines, Iowa, 50314
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Edmond, Oklahoma, 73034
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Englewood, Colorado, 80113
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Glendora, California, 91741
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Indianapolis, Indiana, 46256
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Irvine, California, 92618
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Jacksonville, Florida, 32209
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Knoxville, Tennessee, 37920
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Las Vegas, Nevada, 89117
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Long Beach, California, 90806
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Newport Beach, California, 92660
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Olympia, Washington, 98502
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Overland Park, Kansas, 66215
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Phoenix, Arizona, 85050
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Plantation, Florida, 33317
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Raleigh, North Carolina, 27607
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Sacramento, California, 95825
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Salisbury, North Carolina, 28144
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San Antonio, Texas, 78229
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San Diego, California, 92120
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Shreveport, Louisiana, 71106
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Spokane, Washington, 99202
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St Louis, Missouri, 63141
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Topeka, Kansas, 66606
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Troy, Michigan, 48084
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Vacaville, California, 95688

Other trials in United States

About this study

Official title: A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction

Conditions: Erectile Dysfunction
Being tested: LY2452473, tadalafil, placebo (tadalafil), placebo (LY2452473)
Medical subject headings: Erectile Dysfunction

What participants receive

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

LY2452473Drug
Administered orally, once daily for 12 weeks
tadalafilDrug
Administered orally, once daily for 12 weeks
placebo (tadalafil)Drug
Administered orally, once daily for 12 weeks
placebo (LY2452473)Drug
Administered orally, once daily for 12 weeks

Study groups in NCT01160289
Study group	Role	What they receive
1 milligram (mg) LY2452473 + 5 mg tadalafil	Experimental	Not described Receives: Drug: LY2452473; Drug: tadalafil; Drug: placebo (tadalafil)
5 mg LY2452473 + 5 mg tadalafil	Experimental	Not described Receives: Drug: LY2452473; Drug: tadalafil; Drug: placebo (tadalafil)
5 mg LY2452473 + placebo	Experimental	Not described Receives: Drug: LY2452473; Drug: placebo (tadalafil)
10 mg tadalafil + placebo	Active comparator	Not described Receives: Drug: tadalafil; Drug: placebo (tadalafil); Drug: placebo (LY2452473)
5 mg tadalafil + placebo	Active comparator	Not described Receives: Drug: tadalafil; Drug: placebo (tadalafil); Drug: placebo (LY2452473)

What is being measured

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

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Measured: Baseline, Week 12

Secondary outcomes (9)

Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25).
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)
The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Measured: Baseline, Week 12
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Glucose
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Measured: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Insulin
Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Measured: Baseline, Week 12

Timeline

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

Oct 2010Nov 2011

First posted12 Jul 2010 (estimated)
Study startOct 2010
Primary completionNov 2011
Study completionNov 2011

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 Erectile DysfunctionStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 410 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01160289
Sponsor's protocol ID: 11888
Other IDs: I4K-MC-GPEC
Status last verified: Mar 2019
First submitted: 8 Jul 2010
Last updated: 9 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction
ClinicalTrials.gov ID: NCT01160289
Acronym / sponsor ID: 11888
Conditions: Erectile Dysfunction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 410 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 12 Jul 2010 (estimated)
Results: Posted 9 Apr 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
1 milligram (mg) LY2452473 + 5 mg tadalafil	Experimental	Drug: LY2452473, Drug: tadalafil, Drug: placebo (tadalafil)
5 mg LY2452473 + 5 mg tadalafil	Experimental	Drug: LY2452473, Drug: tadalafil, Drug: placebo (tadalafil)
5 mg LY2452473 + placebo	Experimental	Drug: LY2452473, Drug: placebo (tadalafil)
10 mg tadalafil + placebo	Active comparator	Drug: tadalafil, Drug: placebo (tadalafil), Drug: placebo (LY2452473)
5 mg tadalafil + placebo	Active comparator	Drug: tadalafil, Drug: placebo (tadalafil), Drug: placebo (LY2452473)

Who may qualify

Ages: 45 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Ambulatory men
History of erectile dysfunction of at least 3 months duration
History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label
Anticipate having the same female sexual partner throughout the duration of the study
Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study

Key exclusion criteria (24 listed)

History of penile implant
History of no response to injection therapy for erectile dysfunction
History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection
Exhibit the presence of clinically significant penile deformity in the opinion of the investigator
History of prior sexual legal convictions

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
LY2452473Administered orally, once daily for 12 weeks	Drug	1 milligram (mg) LY2452473 + 5 mg tadalafil, 5 mg LY2452473 + 5 mg tadalafil, 5 mg LY2452473 + placebo
tadalafilAdministered orally, once daily for 12 weeks	Drug	1 milligram (mg) LY2452473 + 5 mg tadalafil, 10 mg tadalafil + placebo, 5 mg LY2452473 + 5 mg tadalafil, 5 mg tadalafil + placebo
placebo (tadalafil)Administered orally, once daily for 12 weeks	Drug	1 milligram (mg) LY2452473 + 5 mg tadalafil, 10 mg tadalafil + placebo, 5 mg LY2452473 + 5 mg tadalafil, 5 mg LY2452473 + placebo, 5 mg tadalafil + placebo
placebo (LY2452473)Administered orally, once daily for 12 weeks	Drug	10 mg tadalafil + placebo, 5 mg tadalafil + placebo

Primary outcome

Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
Time frame: Baseline, Week 12
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.

9 secondary outcomes

Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
Time frame: Baseline, Week 12
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Glucose
Time frame: Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Insulin
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 9 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Screened Subjects	894	410
1 mg LY2452473 and 5 mg Tadalafil	0	0
5 mg LY2452473 and 5 mg Tadalafil	0	0
5 mg LY2452473	0	0
10 mg Tadalafil	0	0
5 mg Tadalafil	0	0

Primary outcome: Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	1 mg LY2452473 and 5 mg Tadalafil n = 66	5 mg LY2452473 and 5 mg Tadalafil n = 74	5 mg LY2452473 n = 34	10 mg Tadalafil n = 83	5 mg Tadalafil n = 74
Value	2.515 (6.019)	2.405 (6.920)	-0.971 (6.699)	3.530 (5.640)	2.054 (4.800)

1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil: p = 0.5, ANCOVA
5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil: p = 0.498, ANCOVA

Population analysed: Randomized participants who received at least 1 dose of study drug \[intention-to-treat (ITT) population\] and had non-missing IIEF EF domain scores at baseline and at Week 12; Last observation carried forward (LOCF) applied to statistical analyses.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5 mg Tadalafil, Lead-in Period	2 of 531 (0.4%)	88 of 531 (16.6%)	Not reported
1 mg LY2452473 and 5 mg Tadalafil	2 of 85 (2.4%)	27 of 85 (31.8%)	Not reported
5 mg LY2452473 and 5 mg Tadalafil	1 of 97 (1%)	23 of 97 (23.7%)	Not reported
5 mg LY2452473	1 of 52 (1.9%)	10 of 52 (19.2%)	Not reported
10 mg Tadalafil	0 of 89 (0%)	34 of 89 (38.2%)	Not reported
5 mg Tadalafil	0 of 87 (0%)	33 of 87 (37.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2452473 and tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 36 sites 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 24 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites 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. 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 9 Apr 2019). 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 From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score (time frame: Baseline, Week 12). 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 NCT01160289.

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 9 Apr 2019.