Benign Prostatic HyperplasiaPhase 3NCT01139762

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

A Phase 3 study testing Tadalafil and Finasteride in people with Benign Prostatic Hyperplasia and Enlarged Prostate, run by Eli Lilly and Company at 65 sites in 13 countries.

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 purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement. Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia, Enlarged Prostate
What is being tested?: Tadalafil and Finasteride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 696 participants
Where: 65 sitesin 13 countries
Study dates: Sep 2010to May 2012
Phase: Phase 3
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
Finasteride or dutasteride use at any time.
Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
Have prostate enlargement measured by ultrasound at screening.

Who cannot join

Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study].
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have problems with kidneys, liver, or nervous system
Have uncontrolled diabetes
Have had a stroke or a significant injury to brain or spinal cord.
Have scheduled or planned surgery during the course of the study.

Trial locations and contacts

65 sites in 13 countries.

Country

City, postcode or hospital

65 sites in 13 countries

United States10 sites

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Davis, California, 95616
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Fresno, California, 93720
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Georgetown, Texas, 78626
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Laguna Hills, California, 92367
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Long Beach, California, 90806
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Sarasota, Florida, 34237
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Shreveport, Louisiana, 71106
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St. Petersburg, Florida, 33710
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Vacaville, California, 95688
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West Palm Beach, Florida, 33407

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Canada9 sites

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Abbottsford, British Columbia, V2S 3N5
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Calgary, Alberta, T2W 1P9
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Kitchener, Ontario, N2N 3B9
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North York, Ontario, M6A 3B5
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Pointe-Claire, Quebec, H9R 4S3
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Surrey, British Columbia, V3V 1N1
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Thunder Bay, Ontario, P7E 6E7
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Trois-Rivières, Quebec, G9A3V7
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Victoria, British Columbia, V8V 3N1

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Mexico6 sites

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Chihuahua City, 31000
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Colima, 28000
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Guadalajara, 44610
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Mexico City, 06700
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Saltillo, 25210
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Tlalpan, 14000

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France5 sites

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Nantes, 44093
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Nîmes, 30029
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Orléans, 45067
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Suresnes, 92150
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Vandœuvre-lès-Nancy, 54511

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Greece5 sites

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Athens, 10552
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Heraklion, 71110
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Larissa, 41221
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Pátrai, 26500
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Thessaloniki, 56429

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Italy5 sites

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Bergamo, 24128
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Milan, 20122
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Naples, 80131
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Rome, 00189
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Sassari, 07100

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Belgium4 sites

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Brussels, 1090
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Edegem, 2650
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Ghent, 9000
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Kortrijk, 8500

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Germany4 sites

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Berlin, 13465
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Hettstedt, 06333
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Leipzig, 04109
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Mühlacker, 75417

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Poland4 sites

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Bydgoszcz, 85-168
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Kutno, 99-300
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Poznan, 61-251
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Zabrze, 41-800

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Russia4 sites

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Moscow, 109472
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Rostov-on-Don, 344011
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Saint Petersburg, 197136
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Saratov, 410026

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Turkey (Türkiye)4 sites

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Adana, 1330
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Denizli, 06111
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Istanbul, 34303
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Izmir, 35340

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Brazil3 sites

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Porto Alegre, 90610-970
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Rio de Janeiro, 20551-030
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São Paulo, 04262-000

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Argentina2 sites

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Buenos Aires, C1060AAA
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Córdoba, X5016KEH

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About this study

Official title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

Conditions: Benign Prostatic Hyperplasia, Enlarged Prostate
Being tested: Tadalafil, Placebo, Finasteride
Keywords: Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

TadalafilDrug
Also called Cialis, LY#450190
5 milligrams (mg) administered orally, once daily for 26 weeks
PlaceboDrug
Administered orally, once daily for 26 weeks
FinasterideDrug
5mg administered orally, once daily for 26 weeks

Study groups in NCT01139762
Study group	Role	What they receive
Tadalafil	Experimental	Not described Receives: Drug: Tadalafil; Drug: Finasteride
Placebo	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Finasteride

What is being measured

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

Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Measured: Baseline, 12 weeks

Secondary outcomes (13)

Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 26 weeks
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
IPSS Quality of Life Index assesses participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
Measured: 26 weeks
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks
The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.
Measured: 26 weeks
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
Measured: 26 weeks
Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks
Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.
Measured: Baseline, 26 weeks
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Measured: Baseline, 4 weeks, 12 weeks, 26 weeks

Timeline

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

Sep 2010May 2012

First posted9 Jun 2010 (estimated)
Study startSep 2010
Primary completionFeb 2012
Study completionMay 2012

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 (1)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 696 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01139762
Sponsor's protocol ID: 13529
Other IDs: H6D-CR-LVIW
Status last verified: Jan 2013
First submitted: 1 Jun 2010
Last updated: 27 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Buttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.
PubMed 25353053

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 Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT01139762
Acronym / sponsor ID: 13529
Conditions: Benign Prostatic Hyperplasia, Enlarged Prostate
Keywords: Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 696 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Feb 2012 (actual)
Study completion: May 2012 (actual)
First posted: 9 Jun 2010 (estimated)
Results: Posted 27 Feb 2013

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tadalafil	Experimental	Drug: Tadalafil, Drug: Finasteride
Placebo	Placebo comparator	Drug: Placebo, Drug: Finasteride

Who may qualify

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

Key inclusion criteria (7 listed)

Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
Have prostate enlargement measured by ultrasound at screening.

Key exclusion criteria (6 listed)

Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study].
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have problems with kidneys, liver, or nervous system
Have uncontrolled diabetes
Have had a stroke or a significant injury to brain or spinal cord.

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
TadalafilAlso: Cialis, LY#4501905 milligrams (mg) administered orally, once daily for 26 weeks	Drug	Tadalafil
PlaceboAdministered orally, once daily for 26 weeks	Drug	Placebo
Finasteride5mg administered orally, once daily for 26 weeks	Drug	Placebo, Tadalafil

Primary outcome

Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
Time frame: Baseline, 12 weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.

13 secondary outcomes

Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
Time frame: Baseline, 4 weeks, 26 weeks
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
Time frame: 26 weeks
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks
Time frame: 26 weeks
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
Time frame: 26 weeks
Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks
Time frame: Baseline, 26 weeks
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks

Results and safety

Results posted to the registry on 27 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Screening-Washout and Placebo Lead-In	1,070	696
Tadalafil	0	0
Placebo	0	0

Primary outcome: Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks

Time frame: Baseline, 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tadalafil n = 345	Placebo n = 350
Value	-5.18 (0.32)	-3.76 (0.32)

Tadalafil vs Placebo: LS Mean Difference: -1.41 (95% CI -2.27 to -0.55), p = 0.001, Mixed Model Repeated Measures Analysis

Population analysed: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening-Washout and Placebo Lead-In	1 of 1,070 (0.1%)	153 of 1,070 (14.3%)	Not reported
Tadalafil	9 of 345 (2.6%)	105 of 345 (30.4%)	Not reported
Placebo	5 of 350 (1.4%)	94 of 350 (26.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25353053Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Buttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.

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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

65 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil and Finasteride in people with Benign Prostatic Hyperplasia and Enlarged Prostate, run by Eli Lilly and Company at 65 sites in 13 countries.

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 7 inclusion and 6 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 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada, Mexico, France, Greece and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Feb 2013). 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 Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks (time frame: Baseline, 12 weeks). 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 NCT01139762, which also lists 1 linked publication.

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 27 Feb 2013.