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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01097707




Registration number
NCT01097707
Ethics application status
Date submitted
31/03/2010
Date registered
2/04/2010
Date last updated
8/04/2019

Titles & IDs
Public title
A Study in Men With Benign Prostatic Hyperplasia
Scientific 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)
Secondary ID [1] 0 0
I1A-MC-BPAE
Secondary ID [2] 0 0
10373
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY500307
Treatment: Drugs - Placebo

Experimental: 1mg LY500307 -

Experimental: 3mg LY500307 -

Experimental: 10mg LY500307 -

Experimental: 25mg LY500307 -

Placebo Comparator: Placebo -


Treatment: Drugs: LY500307
Administered orally, daily for 24 weeks

Treatment: Drugs: Placebo
Administered orally, daily for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Timepoint [1] 0 0
Baseline, 24 weeks
Secondary outcome [1] 0 0
Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)
Timepoint [1] 0 0
Baseline, 24 weeks
Secondary outcome [2] 0 0
Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)
Timepoint [2] 0 0
Baseline, 24 weeks
Secondary outcome [3] 0 0
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)
Timepoint [3] 0 0
Baseline, 24 weeks
Secondary outcome [4] 0 0
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores
Timepoint [4] 0 0
Baseline, 24 weeks
Secondary outcome [5] 0 0
Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)
Timepoint [5] 0 0
Baseline, 24 weeks
Secondary outcome [6] 0 0
Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone
Timepoint [6] 0 0
Baseline, 24 weeks
Secondary outcome [7] 0 0
Change From Baseline to 24-Week Endpoint in Lipid Profile
Timepoint [7] 0 0
Baseline, 24 weeks

Eligibility
Key inclusion criteria
- 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.

- Have not received the following treatments within the specified time period:

1. Finasteride or dutasteride for at least 6 months prior to screening.

2. Any alpha-adrenergic antagonists for at least 4 weeks prior to screening.

3. Any other non-experimental BPH therapy (including an herbal preparation) for at
least 4 weeks prior to screening.

4. Any other experimental or off-label BPH therapy such as injectable therapies with
a protracted effect for at least 6 months prior to screening.

5. Any overactive bladder treatment for at least 4 weeks prior to screening.

6. 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.
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- 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:

1. Recent Myocardial infarction, unstable angina, stroke or Transient ischemic
attack within 6 months of screening.

2. Recent coronary intervention that includes coronary artery bypass surgery,
percutaneous coronary artery intervention, or stent placement within 6 months of
screening.

3. Recent history of positive stress tests without any written documentation of
effective intervention within 6 months of screening.

4. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
414
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
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. - Adelaide
Recruitment hospital [2] 0 0
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. - Bentleigh East
Recruitment hospital [3] 0 0
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. - Mentone
Recruitment hospital [4] 0 0
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. - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 0 0
3194 - Mentone
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Indiana
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Iowa
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Kansas
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Louisiana
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Maryland
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Michigan
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Montana
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New York
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North Carolina
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France
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Lyon
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Nimes
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France
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Orleans
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France
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Toulouse
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Germany
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Berlin
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Hamburg
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Marburg
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Heraklion
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Larissa
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Patras
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Thessaloniki
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Cefala
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Italy
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Firenze
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Italy
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Rome
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Russian Federation
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Moscow
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Saint Petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic
Hyperplasia (BPH)
Trial website
https://clinicaltrials.gov/ct2/show/NCT01097707
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01097707