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 hyperplasia; MedDRA version: 12.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia

• Registration Number: EUCTR2009-016800-22-GR
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 575

Inclusion Criteria

Only male patients are eligible to be included in the study and only if they meet all of the following criteria:
[1] Present at Visit 1 with a history of BPH based on the diagnostic criteria (see Section 8.1.1).
[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 (Visit 1).
[4] Have an IPSS =13 at the placebo lead-in visit (Visit 2).
[5] Have a TPV by TRUS =30 mL at the placebo lead-in visit (Visit 2).
[6] Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) =4 and =15 mL/sec (from a prevoid total bladder volume [assessed by ultrasound or echography] of =150 to = 550 mL and a minimum voided volume of 125 mL) at Visit 2.
[7] Have a PSA =1.4 and =10 ng/mL at screening (Visit 1). 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 Visit 1 or prior to the patient’s Visit 2.
[7a] If the PSA criterion is not met at screening (Visit 1), the patient may undergo 1 retest if active new patient screening is ongoing.
[8] Demonstrate a PVR =300 mL by ultrasound or echography at the placebo lead-in visit (Visit 2).
[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 Visit 2.
[9b] Any alpha-adrenergic antagonists for at least 4 weeks prior to Visit 2.
[9c] Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to Visit 2.
[9d] Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to Visit 2.
[9e] Any overactive bladder treatment for at least 4 weeks prior to Visit 2.
[9f] Any ED treatment which may include oral PDE type 5 inhibitors or devices for at least 4 weeks prior to Visit 2.
[10] Have a morning fasting TT concentration =300 ng/dL (=3.0ng/mL, =10.40nmol/L) at screening (Visit 1).
[10a] If the TT criterion is not met at screening (Visit 1), the patient may undergo 1 retest if active new patient screening is ongoing.
[11] If currently taking statin treatment, must be stable on treatment as determined by the investigator for at least 2 months prior to Visit 2.
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

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
General Exclusion Criteria
[12] 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.
[13] Are Lilly employees.
[14] Are currently enrolled in, or discontinued within the last 30 days (at Visit 1) 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.
[15] Have completed or withdrawn from this study after exposure to study drug or have completed or withdrawn from any other study investigating LY500307 after exposure to study drug. Patients who previously screen failed from this study [based upon protocol version (a)] but who the investigator determines may now meet criteria will be allowed to rescreen for the study 1 time as long as the patient was not previously exposed to study drug (including placebo lead-in).
[16] 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.
Medical Condition Criteria
[17] 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).
[18] Have active cardiovascular disease as evidenced by the following (18a through 18d):
[18a] Recent MI, unstable angina, stroke or TIA within 6 months of Visit 2.
[18b] Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of Visit 2.
[18c] Recent history of positive stress tests without any written documentation of effective intervention within 6 months of Visit 2.
[18d] Evidence of heart disease categorized as =Class III functional classification of NYHA (Attachment 10) within 6 months of Visit 2.
[19] 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).
[20] Have a history of deep venous thrombosis or pulmonary embolism disease.
[21] Have moderate to severe renal insufficiency (defined as an eGFR <50 mL/min/1.73m2 calculated from the MDRD formula [Huang et al. 2009]).
[21a] If the eGFR criterion is not met at screening (Visit 1), the patient may undergo 1 retest of initial screening if new patient screening is ongoing.
[22] Have a hemoglobin A1c (HbA1c) >9.0%.
[23] 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 Visit 1); or are on long-acting formulations of testosterone replacement therapy, within 3 half-lifes prior to Visit 1. Patients on stable doses of thyroid replacement therapy will be allowed in this study.
[24] Are on non-statin pharmacological agents for treatment of hyperlipidemia. Non-prescription strength fish oil use for prophylactic purposes is allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified