A Study in Men With Benign Prostatic Hyperplasia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01097707
• Date of registration: 31/03/2010
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• 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)
• Date of first enrolment: April 2010
• Target sample size: 414
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01097707
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, France, Germany, Greece, Italy, Russian Federation, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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.

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.



Age minimum: 45 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia

Intervention(s)

Drug: LY500307

Drug: Placebo

Primary Outcome(s)

Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score [Time Frame: Baseline, 24 weeks]

Secondary Outcome(s)

Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores [Time Frame: Baseline, 24 weeks]

Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax) [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 International Prostate Symptom Score-Quality of Life Index (IPSS-QoL) [Time Frame: Baseline, 24 weeks]

Change From Baseline to 24-Week Endpoint in Lipid Profile [Time Frame: Baseline, 24 weeks]

Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV) [Time Frame: Baseline, 24 weeks]

Secondary ID(s)

10373

I1A-MC-BPAE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01097707