Benign Prostatic HyperplasiaPhase 1NCT01183650

A Study of Tadalafil in Benign Prostatic Hyperplasia

A Phase 1 study testing Tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 1 site in Germany.

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 pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH). The safety of tadalafil will also be studied. Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteGermany
Study dates: Jul 2010to Apr 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have had lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) (as diagnosed by a qualified physician) >6 months at screening visit. Lower urinary tract symptoms (LUTS) include those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining) and/or storage (irritative symptoms, such as frequency, urgency, nocturia).
Have BPH-LUTS with moderate-to-severe symptoms confirmed by an International Prostate Symptom Score (IPSS) >12. (The IPSS total score is defined as the sum of Questions 1 through 7 and does not include the IPSS Quality of Life.)
Taking into account the age and disease status, subjects determined to be in good health according to medical history, physical examination, electrocardiogram (ECG), and laboratory safety assessments.
Body mass index between 18 and 30 kg/m^2 inclusive.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments, including alpha blockers, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at least 1 week prior to dosing and through to follow-up.
Subjects with a serum prostate-specific antigen (PSA) <10.0 ng/mL. Subjects with a serum PSA greater than or equal to 4.0 and <10.0 ng/mL must have documentation of a negative histologic biopsy of carcinoma of the prostate within 12 months prior to screening.

Who cannot join

History of radical prostatectomy, or other pelvic surgery or procedure, including any pelvic surgical procedure on the urinary tract apart from transurethral resection, pelvic surgery for malignancy or bowel resection, or a history of lower urinary tract malignancy or trauma. History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening.
Current or previous history of malignant disease of the prostate.
Concomitant treatment with or ingestion of cytochrome P 450 3A4 (CYP3A4)-inducing or -inhibiting agents from 2 weeks prior to dosing and through the end of the study. Including herbal/food and other supplements, fruit, or fruit juices containing grapefruit or pomegranate components.
History of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Subjects with chronic stable angina treated with long-acting nitrates, subjects with chronic stable angina who required short-acting nitrates in the 90 days prior to screening visit, or subjects with angina occurring during sexual intercourse in the 6 months prior to screening.
Subjects having met the criteria for unstable angina within 6 months prior to screening, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days prior to screening.
Any evidence of heart disease (New York Heart Association [NYHA] greater than or equal to Class III) within 6 months of screening.
A history of cardiac arrest.

Trial locations and contacts

1 site in 1 country.

Germany1 site

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.
Munich, 80636

Other trials in Germany

About this study

Official title: A Study to Evaluate the Pharmacokinetics of Tadalafil Administered Once Daily in Japanese and Non-Japanese Subjects With Benign Prostatic Hyperplasia

The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH).

The safety of tadalafil will also be studied.

Conditions: Benign Prostatic Hyperplasia
Being tested: Tadalafil
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 LY450190, Cialis, Adcirca
5 mg, administered orally, daily for 10 days

Study groups in NCT01183650
Study group	Role	What they receive
Tadalafil	Experimental	5 mg, administered orally, daily for 10 days Receives: Drug: Tadalafil

What is being measured

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

Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710
AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.
Measured: 1 day and 10 days
Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710
Measured: 1 day and 10 days
Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710
Measured: 1 day and 10 days

Timeline

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

Jul 2010Apr 2011

First posted17 Aug 2010 (estimated)
Study startJul 2010
Primary completionApr 2011
Study completionApr 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 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 1
Primary purpose: Basic science
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01183650
Sponsor's protocol ID: 13910
Other IDs: H6D-MC-LVIY
Status last verified: Apr 2012
First submitted: 13 Aug 2010
Last updated: 16 May 2012
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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Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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RecruitingObservational study
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BPH With Symptomatic Lower Urinary Tract Symptoms
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Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics of Tadalafil Administered Once Daily in Japanese and Non-Japanese Subjects With Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT01183650
Acronym / sponsor ID: 13910
Conditions: Benign Prostatic Hyperplasia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 17 Aug 2010 (estimated)
Results: Posted 16 May 2012

Clinical summary

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

The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH).

The safety of tadalafil will also be studied.

Study design

Primary purpose: Basic science
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tadalafil	Experimental	Drug: Tadalafil5 mg, administered orally, daily for 10 days

Who may qualify

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

Key inclusion criteria (6 listed)

Have had lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) (as diagnosed by a qualified physician) >6 months at screening visit. Lower urinary tract symptoms (LUTS) include those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining) and/or storage (irritative symptoms, such as frequency, urgency, nocturia).
Have BPH-LUTS with moderate-to-severe symptoms confirmed by an International Prostate Symptom Score (IPSS) >12. (The IPSS total score is defined as the sum of Questions 1 through 7 and does not include the IPSS Quality of Life.)
Taking into account the age and disease status, subjects determined to be in good health according to medical history, physical examination, electrocardiogram (ECG), and laboratory safety assessments.
Body mass index between 18 and 30 kg/m^2 inclusive.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments, including alpha blockers, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at least 1 week prior to dosing and through to follow-up.

Key exclusion criteria (8 listed)

History of radical prostatectomy, or other pelvic surgery or procedure, including any pelvic surgical procedure on the urinary tract apart from transurethral resection, pelvic surgery for malignancy or bowel resection, or a history of lower urinary tract malignancy or trauma. History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening.
Current or previous history of malignant disease of the prostate.
Concomitant treatment with or ingestion of cytochrome P 450 3A4 (CYP3A4)-inducing or -inhibiting agents from 2 weeks prior to dosing and through the end of the study. Including herbal/food and other supplements, fruit, or fruit juices containing grapefruit or pomegranate components.
History of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Subjects with chronic stable angina treated with long-acting nitrates, subjects with chronic stable angina who required short-acting nitrates in the 90 days prior to screening visit, or subjects with angina occurring during sexual intercourse in the 6 months prior to screening.

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: LY450190, Cialis, Adcirca5 mg, administered orally, daily for 10 days	Drug	Tadalafil

Primary outcome

Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710
Time frame: 1 day and 10 days
AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.
Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710
Time frame: 1 day and 10 days
Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710
Time frame: 1 day and 10 days

Results and safety

Results posted to the registry on 16 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Japanese Participants	12	12
Caucasian Participants	12	12

Primary outcome: Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710

Time frame: 1 day and 10 days. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour/milliliter (ng*hr/mL)

Measure	Japanese Participants n = 12	Caucasian Participants n = 12
Day 1 Tadalafil	1410 (31)	1340 (17)
Day 10 Tadalafil	2710 (27)	3410 (51)
Day 1 Metabolite IC710	525 (27)	399 (23)
Day 10 Metabolite IC710	2270 (30)	2290 (48)

Japanese Participants vs Caucasian Participants: Ratio of Geometric Least Squares Means: 1.05 (90% CI 0.84 to 1.32)
Japanese Participants vs Caucasian Participants: Ratio of Geometric Least Squares Means: 0.80 (90% CI 0.64 to 1.00)
Japanese Participants vs Caucasian Participants: Ratio of Geometric Least Squares Means: 1.31 (90% CI 1.05 to 1.64)

Population analysed: All enrolled participants

Primary outcome: Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710

Time frame: 1 day and 10 days. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Japanese Participants n = 12	Caucasian Participants n = 12
Day 1 Tadalafil	102 (27)	104 (19)
Day 10 Tadalafil	173 (24)	215 (36)
Day 1 Metabolite IC710	32.1 (25)	24.0 (26)
Day 10 Metabolite IC710	105 (31)	102 (47)

Japanese Participants vs Caucasian Participants: Ratio of Geometric Least Squares Means: 0.98 (90% CI 0.81 to 1.18)
Japanese Participants vs Caucasian Participants: Ratio of Geometric Least Squares Means: 0.81 (90% CI 0.67 to 0.97)
Japanese Participants vs Caucasian Participants: Ratio of Geometric Least Squares Mean: 1.33 (90% CI 1.07 to 1.67)

Population analysed: All enrolled participants

Primary outcome: Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710

Time frame: 1 day and 10 days. Median (Full Range). Unit: hours

Measure	Japanese Participants n = 12	Caucasian Participants n = 12
Day 1 Tadalafil	4.00 (1.00 to 4.00)	2.00 (1.00 to 4.00)
Day 10 Tadalafil	3.00 (2.00 to 4.00)	2.53 (1.00 to 4.00)
Day 1 Metabolite IC710	23.83 (23.83 to 23.83)	24.00 (16.02 to 24.03)
Day 10 Metabolite IC710	4.00 (0.00 to 24.00)	8.00 (0.00 to 24.00)

Japanese Participants: Median Difference (Final Values): 0.00, Wilcoxon (Mann-Whitney)
Caucasian Participants: Median Difference (Final Values): 0.00, Wilcoxon (Mann-Whitney)
Japanese Participants: Median Difference (Final Values): 19.83, Wilcoxon (Mann-Whitney)

Population analysed: All enrolled participants

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Japanese Participants	0 of 12 (0%)	0 of 12 (0%)	Not reported
Caucasian Participants	0 of 12 (0%)	12 of 12 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tadalafil in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 1 site in Germany.

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 6 inclusion and 8 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 16 May 2012. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 16 May 2012). 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?

Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710 (time frame: 1 day and 10 days). The study lists 3 primary outcomes in all. 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 NCT01183650.

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 16 May 2012.