Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
50–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent obtained before any trial-related activity is performed
Men, aged 50 or older
Clinical signs and symptoms of BPH for ≥6 months
Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) ≥13
An IPSS QoL score of ≥3 at screening
Prostate specific antigen (PSA) at screening ≤10 ng/mL (responsibility of the Investigator to rule out prostate cancer when PSA is \>4 ng/mL, except in the USA where patients with a PSA \>4 and ≤10 ng/mL should undergo a prostatic biopsy or have a negative prostatic biopsy within 12 months prior to participation in the trial)
Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume \>125 mL at screening
You may not be if
Post void residual volume (PVR) \>250 mL
Stone in the bladder or urethra causing symptoms
Acute or chronic prostatitis
Interstitial cystitis / painful bladder syndrome
Acute or recurrent urinary tract infections
History of acute urinary retention (AUR)
Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2
Clinical evidence of any of the following urinary tract conditions:
1. Mullerian duct cysts
2. Atonic, decompensated, or hypocontractile bladder
3. Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation)
History of any of the following pelvic conditions:
1. Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery
2. Pelvic radiotherapy
3. Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies
4. Lower tract malignancy or trauma
Clinically significant microscopic haematuria at screening
History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance \<30 mL/minute at screening
Systolic blood pressure \>180 or \<90 mmHg or diastolic blood pressure \>110 or \<50 mmHg at screening or malignant hypertension
Any causes other than BPH, which may affect evaluation of symptoms of urine flow (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator
Use of any prohibited therapies
Elevated liver function tests at screening:
1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \>2 times the upper limit of normal
2. Total bilirubin \>1.5 times the upper limit of normal
QTc interval on the screening ECG \>450 ms, or a family history of long QT syndrome
Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator
Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
Mental incapacity or language barrier precluding adequate understanding or co-operation
History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening
Hypersensitivity towards any component of the investigational medicinal product (IMP)
