Benign Prostatic HyperplasiaPhase 2NCT00783094

Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

A Phase 2 study testing Tadalafil 2.5 mg and Tadalafil 5 mg in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 6 sites in Japan.

Completed

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

Official record

Search all trials

Trial summary

This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign… 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 2.5 mg and Tadalafil 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 422 participants
Where: 6 sitesJapan
Study dates: Nov 2008to Apr 2010
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.

Who cannot join

Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 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.
Chiba, 274-0825
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.
Hiroshima, 730-0013
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.
Kanagawa, 226-0025
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.
Kyoto, 607-8085
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.
Osaka, 561-0832
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.
Tokyo, 150-0002

Other trials in Japan

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions: Benign Prostatic Hyperplasia
Being tested: Tadalafil 2.5 mg, Tadalafil 5 mg, Placebo
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

Tadalafil 2.5 mgDrug
Also called LY450190, Cialis
oral, daily
Tadalafil 5 mgDrug
Also called LY450190, Cialis
oral, daily
PlaceboDrug
oral, daily

Study groups in NCT00783094
Study group	Role	What they receive
Tadalafil 2.5 milligrams (mg)	Experimental	2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks. Receives: Drug: Tadalafil 2.5 mg
Tadalafil 5 mg	Experimental	5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks. Receives: Drug: Tadalafil 5 mg
Placebo	Placebo comparator	Placebo tablet taken by mouth once a day for 12 weeks. Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: Baseline, 12 weeks

Secondary outcomes (22)

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Measured: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Measured: Baseline, 12 weeks
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Measured: Baseline, 12 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Measured: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Measured: Baseline, 12 weeks
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Measured: Baseline, 12 weeks
Number of Participants With Adverse Events During 12 Weeks of the Study
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Measured: Baseline through 12 weeks
Change From Baseline in Blood Pressure at 12-Week Endpoint
Measured: Baseline, 12 weeks
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Measured: Baseline, 12 Weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Measured: Baseline, 12 weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Measured: Baseline, 12 weeks
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: Baseline, 54 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Measured: Baseline, 54 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Measured: Baseline, 54 weeks
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Measured: Baseline, 54 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Measured: Baseline, 54 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Measured: Baseline, 54 weeks
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Measured: End of 12 weeks of double-blind through 54 weeks
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Measured: Baseline, 54 weeks
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Measured: Baseline, 54-weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Measured: Baseline, 54 weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Post residual volume (PVR) is measured by ultrasound at regular intervals.
Measured: Baseline, 54 weeks

Timeline

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

Nov 2008Apr 2010

First posted31 Oct 2008 (estimated)
Study startNov 2008
Primary completionJun 2009
Study completionApr 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 422 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00783094
Sponsor's protocol ID: 12757
Other IDs: H6D-JE-LVIA
Status last verified: Mar 2011
First submitted: 30 Oct 2008
Last updated: 29 Mar 2011
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 Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT00783094
Acronym / sponsor ID: 12757
Conditions: Benign Prostatic Hyperplasia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 422 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jun 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 28 Jul 2010

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: 3

Arm	Type	Receives
Tadalafil 2.5 milligrams (mg)	Experimental	Drug: Tadalafil 2.5 mg2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Tadalafil 5 mg	Experimental	Drug: Tadalafil 5 mg5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablet taken by mouth once a day for 12 weeks. Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.

Who may qualify

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

Key inclusion criteria (3 listed)

Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.

Key exclusion criteria (8 listed)

Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.

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
Tadalafil 2.5 mgAlso: LY450190, Cialisoral, daily	Drug	Tadalafil 2.5 milligrams (mg)
Tadalafil 5 mgAlso: LY450190, Cialisoral, daily	Drug	Tadalafil 5 mg
Placebooral, daily	Drug	Placebo

Primary outcome

Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
Time frame: Baseline, 12 weeks
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

22 secondary outcomes

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Time frame: Baseline, 12 weeks
Number of Participants With Adverse Events During 12 Weeks of the Study
Time frame: Baseline through 12 weeks
Change From Baseline in Blood Pressure at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Time frame: Baseline, 12 Weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Time frame: Baseline, 12 weeks
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
Time frame: End of 12 weeks of double-blind through 54 weeks
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Time frame: Baseline, 54-weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Time frame: Baseline, 54 weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Time frame: Baseline, 54 weeks

Results and safety

Results posted to the registry on 28 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tadalafil 2.5 mg	142	135
Tadalafil 5 mg	140	128
Placebo	140	131

Primary outcome: Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint

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

Measure	Tadalafil 2.5 mg n = 142	Tadalafil 5 mg n = 140	Placebo n = 139
Value	-4.5 (0.4)	-4.9 (0.4)	-3.8 (0.4)

Tadalafil 2.5 mg vs Placebo: Mean Difference (Final Values): -0.7 (95% CI -1.8 to 0.4), p = 0.201, ANCOVA
Tadalafil 5 mg vs Placebo: Mean Difference (Final Values): -1.1 (95% CI -2.2 to 0.1), p = 0.062, ANCOVA

Population analysed: Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tadalafil 2.5 mg - Double-Blind Phase	2 of 142 (1.4%)	52 of 142 (36.6%)	Not reported
Tadalafil 5 mg - Double-Blind Phase	2 of 140 (1.4%)	54 of 140 (38.6%)	Not reported
Placebo - Double-Blind Phase	1 of 140 (0.7%)	53 of 140 (37.9%)	Not reported
Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label	3 of 135 (2.2%)	81 of 135 (60%)	Not reported
Tadalafil 5 mg: Tadalafil 5 mg Open-Label	4 of 128 (3.1%)	81 of 128 (63.3%)	Not reported
Placebo: Tadalafil 5 mg Open-Label	4 of 131 (3.1%)	94 of 131 (71.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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

6 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 Tadalafil 2.5 mg and Tadalafil 5 mg in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 6 sites in Japan.

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 3 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 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. 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 28 Jul 2010). 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 in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint (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 NCT00783094.

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 29 Mar 2011.