Benign Prostatic HyperplasiaPhase 2NCT01097707
A Study in Men With Benign Prostatic Hyperplasia
A Phase 2 study testing LY500307 in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 70 sites in 8 countries.
Trial summary
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH) 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?
- LY500307
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 70 sitesin 8 countries
- Study dates
- Apr 2010to Oct 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present at screening with a history of benign prostatic hyperplasia (BPH) for >6 months.
- Have an International Prostate Symptom Score (IPSS) greater than or equal to 13 at screening.
- Have a total prostate volume by transrectal ultrasound greater than or equal to 30 milliliter (mL) at screening.
- Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) greater than or equal to 4 and less than or equal to 15 milliliter/second (mL/sec) (from a prevoid total bladder volume [assessed by ultrasound] of greater than or equal to 150 to less than or equal to 550 ml and a minimum voided volume of 125 ml) at screening.
- Have a prostate-specific antigen (PSA) greater than or equal to 1.4 and less than or equal to 10 nanogram/milliliter (ng/mL) at screening.
- Demonstrate a Post Void Residual less than or equal to 300 mL by ultrasound at screening.
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- Have not received the following treatments within the specified time period:
- Finasteride or dutasteride for at least 6 months prior to screening.
- Any alpha-adrenergic antagonists for at least 4 weeks prior to screening.
- Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to screening.
- Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to screening.
- Any overactive bladder treatment for at least 4 weeks prior to screening.
- Any Erectile Dysfunction treatment which may include oral phosphodiesterase type 5 inhibitors or devices for at least 4 weeks prior to screening.
- Have a morning fasting Total Testosterone concentration greater than or equal to 300 nanogram/deciliter (ng/dL) at screening.
- If hyperlipidemic, based on history, be stable on statin treatment as determined by the investigator for at least 2 months prior to screening.
Who cannot join
- Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307.
- Have any history of BPH-related invasive procedures (for example, Transurethral Resection of the Prostate, open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents).
- Have active cardiovascular disease as evidenced by the following:
- Recent Myocardial infarction, unstable angina, stroke or Transient ischemic attack within 6 months of screening.
- Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of screening.
- Recent history of positive stress tests without any written documentation of effective intervention within 6 months of screening.
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- Evidence of heart disease categorized as greater than or equal to Class III functional classification of New York Heart Association (NYHA) within 6 months of screening.
- Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin).
- Have a history of deep venous thrombosis or pulmonary embolism disease.
- Have moderate to severe renal insufficiency.
- Have a hemoglobin A1c (HbA1c) greater than 9.0%.
- Are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis.
- Are on pharmacological treatment other than statins for hyperlipidemia.
Trial locations and contacts
70 sites in 8 countries.
70 sites in 8 countries
United States40 sites
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Anchorage, Alaska, 99508
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Arlington, Texas, 76017
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Aventura, Florida, 33180
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Bala-Cynwyd, Pennsylvania, 19004
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Bradenton, Florida, 34205
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Brooklyn, New York, 11215
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Celebration, Florida, 34747
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Chicago, Illinois, 60611
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Cincinnati, Ohio, 45212
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Coeur d'Alene, Idaho, 83814
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Columbus, Ohio, 43220
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Concord, North Carolina, 28025
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Coral Springs, Florida, 33065
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Dallas, Texas, 75390
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Denver, Colorado, 80210
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Edmond, Oklahoma, 73034
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Fort Wayne, Indiana, 46825
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Garden City, New York, 11530
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Glendora, California, 91741
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Greenbelt, Maryland, 20770
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Huntsville, Alabama, 35801
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Knoxville, Tennessee, 37920
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Meridian, Idaho, 83642
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Middlebury, Connecticut, 06762
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Missoula, Montana, 59808
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New York, New York, 10016
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Newport Beach, California, 92660
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Parker, Colorado, 80134
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Poughkeepsie, New York, 12601
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Salisbury, North Carolina, 28144
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San Antonio, Texas, 78229
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San Bernardino, California, 92404
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San Diego, California, 92103
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Seattle, Washington, 98166
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Shreveport, Louisiana, 71106
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Tarzana, California, 91356
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Troy, Michigan, 48084
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West Des Moines, Iowa, 50266
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Wichita, Kansas, 67708
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Winston-Salem, North Carolina, 27103
Germany7 sites
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Bad Bergzaben, 76887
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Berlin, 14057
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Hamburg, 20354
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Holzminden, D-37603
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Marburg, 35039
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Oranienburg, 16515
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Reutlingen, 72764
France6 sites
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Garches, 92380
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Lyon, 69437
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Nice, 06002
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Nîmes, 30029
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Orléans, 45067
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Toulouse, 31059
Australia4 sites
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Adelaide, South Australia, 5000
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Bentleigh East, Victoria, 3165
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Mentone, Victoria, 3194
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Nedlands, Western Australia, 6009
Greece4 sites
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Heraklion, 71110
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Larissa, 41221
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Pátrai, 26500
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Thessaloniki, 56429
Canada3 sites
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Kitchener, Ontario, N2N 3B9
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Saint John, New Brunswick, E2L 3J8
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Victoria, British Columbia, V8V 3N1
Italy3 sites
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Cefalà Diana, 90015
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Florence, 50012
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Rome, 00161
Russia3 sites
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Moscow, 127473
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Rostov-on-Don, 344011
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Saint Petersburg, 196247
About this study
Official title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- LY500307, 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.
LY500307Drug
Administered orally, daily for 24 weeks
PlaceboDrug
Administered orally, daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1mg LY500307 | Experimental | Not described Receives: Drug: LY500307 |
| 3mg LY500307 | Experimental | Not described Receives: Drug: LY500307 |
| 10mg LY500307 | Experimental | Not described Receives: Drug: LY500307 |
| 25mg LY500307 | Experimental | Not described Receives: Drug: LY500307 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: Baseline, 24 weeks
Secondary outcomes (7)
Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)
The TPV measurement (milliliters) by transrectal ultrasound (TRUS) is an established diagnostic test for men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Measured: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)
Qmax is defined as the peak urine flow rate measured using standard calibrated uroflowmeter.
Measured: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)
IPSS QoL assesses participant's 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.
Measured: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores
IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with a total subscore of the 3 questions for irritative subscore ranging 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 a total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Nocturia Subscore is IPSS Question 7, which assesses how many times over the last month a participant gets up to urinate from the time they went to bed at night until the time they got up in the morning. Scores range from 0=None; 1=1 time; 2= 2 times; 3=3 times; 4=4 times; 5=5 or more times.
Measured: Baseline, 24 weeks
Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)
The units of PSA measurement are nanograms per milliliter (ng/mL).
Measured: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone
Measured: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Lipid Profile
The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Terminated due to insufficient efficacy
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097707
- Sponsor's protocol ID
- 10373
- Other IDs
- I1A-MC-BPAE
- Status last verified
- Mar 2019
- First submitted
- 31 Mar 2010
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT01097707
- Acronym / sponsor ID
- 10373
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to insufficient efficacy
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 8 Apr 2019
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 the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1mg LY500307 | Experimental | Drug: LY500307 |
| 3mg LY500307 | Experimental | Drug: LY500307 |
| 10mg LY500307 | Experimental | Drug: LY500307 |
| 25mg LY500307 | Experimental | Drug: LY500307 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Present at screening with a history of benign prostatic hyperplasia (BPH) for >6 months.
- Have an International Prostate Symptom Score (IPSS) greater than or equal to 13 at screening.
- Have a total prostate volume by transrectal ultrasound greater than or equal to 30 milliliter (mL) at screening.
- Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) greater than or equal to 4 and less than or equal to 15 milliliter/second (mL/sec) (from a prevoid total bladder volume [assessed by ultrasound] of greater than or equal to 150 to less than or equal to 550 ml and a minimum voided volume of 125 ml) at screening.
- Have a prostate-specific antigen (PSA) greater than or equal to 1.4 and less than or equal to 10 nanogram/milliliter (ng/mL) at screening.
Key exclusion criteria (13 listed)
- Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307.
- Have any history of BPH-related invasive procedures (for example, Transurethral Resection of the Prostate, open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents).
- Have active cardiovascular disease as evidenced by the following:
- Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin).
- Have a history of deep venous thrombosis or pulmonary embolism disease.
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 |
|---|---|---|
| LY500307Administered orally, daily for 24 weeks | Drug | 10mg LY500307, 1mg LY500307, 25mg LY500307, 3mg LY500307 |
| PlaceboAdministered orally, daily for 24 weeks | Drug | Placebo |
Primary outcome
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Time frame: Baseline, 24 weeks
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
7 secondary outcomes
Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)
Time frame: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)
Time frame: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)
Time frame: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores
Time frame: Baseline, 24 weeks
Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)
Time frame: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone
Time frame: Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Lipid Profile
Time frame: Baseline, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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
70 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY500307 in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 70 sites in 8 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 15 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 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 70 sites in United States, Germany, France, Australia, Greece and 3 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 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 8 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 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.