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). - BPAE
- Conditions
- Benign prostatic hyperplasiaMedDRA version: 13.1Level: PTClassification code 10004446Term: Benign prostatic hyperplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders
- Registration Number
- EUCTR2009-016800-22-DE
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 575
Only male patients are eligible to be included in the study and only if they meet all of the following criteria:
[1] Present at the time of screening with a history of BPH based on the diagnostic criteria.
[2] Agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
[3] Are at least 45 years of age at the time of screening.
[4] Have an IPSS =13 at placebo lead-in.
[5] Have a TPV by TRUS =30 mL at placebo lead-in.
[6] Show signs of bladder outlet obstruction as defined by a peak urinary flow rate =4 and =15 mL/sec (from a prevoid total bladder volume [assessed by ultrasound] of =150 to = 550 ml and a minimum voided volume of 125 ml) at placebo lead-in.
[7] Have a PSA =1.4 and =10 ng/mL at the time of screening. If, at screening, the patient’s PSA is >4 ng/mL, prostate cancer must be excluded via a documented prostate biopsy within 12 months of screening and prior to the start of the patient’s placebo lead-in.
[8] Demonstrate a PVR =300 mL by ultrasound at placebo lead-in.
[9] Have not received the following treatments within the specified time period (9a through 9f):
[9a] Finasteride or dutasteride for at least 6 months prior to placebo lead-in.
[9b] Any alpha-adrenergic antagonists for at least 4 weeks prior to placebo lead-in.
[9c] Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to placebo lead-in.
[9d] Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to placebo lead-in.
[9e] Any overactive bladder treatment for at least 4 weeks prior to placebo lead-in.
[9f] Any ED treatment which may include oral PDE type 5 inhibitors or devices for at least 4 weeks prior to placebo lead-in.
[10] Have a morning fasting TT concentration =300 ng/dL at screening. If the TT criterion is not met at screening, the patient may undergo 1 retest within 1 month of initial screening if active new patient screening is ongoing
[11] If hyperlipidemic, based on history, be on stable statin treatment as determined by the investigator for at least 2 months prior to placebo lead-in.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[1] Have any history of BPH-related invasive procedures (for example, TURP, open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents).
[2] Have active cardiovascular disease as evidenced by the following (2a through 2d):
[2a] Recent MI, unstable angina, stroke or TIA within 6 months of placebo lead-in.
[2b] Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of placebo lead-in.
[2c] Recent history of positive stress tests without any written documentation of effective intervention within 6 months of placebo lead-in.
[2d] Evidence of heart disease categorized as =Class III functional classification of NYHA within 6 months of placebo lead-in.
[3] 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).
[4] Have a history of deep venous thrombosis or pulmonary embolism disease.
[5] Have moderate to severe renal insufficiency.
[6] Have a hemoglobin A1c (HbA1c) >9.0%.
[7] Are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis, which may include any estrogen preparation, SERMs, GnRH agonists/antagonists, or androgen receptor antagonists within 1 month prior to screening. Patients on stable doses of thyroid replacement therapy will be allowed in this study.
[8] Are on pharmacological treatment other than statins for hyperlipidemia.
[9] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[10] Are Lilly employees.
[11] Are currently enrolled in, or discontinued within the last 30 days (at screening) from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[12] Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307.
[13] Are unable, unreliable, and/or unwilling to provide informed consent, make themselves available for the duration of the study, and refuse to comply with the procedures and study restrictions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method