Phase 3
Completed N=318
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
Source: ClinicalTrials.gov NCT00848081 ↗Enrolled (actual)
318
Serious AEs
1.6%
Results posted
Sep 2010
Primary outcomePrimary: Number of Men With Treatment-emergent Dizziness — 9; 11 Participants — p=0.403
Summary
The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Men With Treatment-emergent Dizziness |
9; 11 | 0.403 |
| SECONDARY Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit |
22; 15; 21; 19; 14; 16 | — |
| SECONDARY International Prostate Symptom Score (IPSS) Change From Baseline |
13.3; 13.87; -1.49; -2.28 | 0.130 |
| SECONDARY Postvoid Residual Volume (PVR) Change From Baseline |
70.7; 80.3; -1.9; -8.1 | 0.258 |
| SECONDARY Uroflowmetry (Qmax) Change From Baseline |
12.8; 11.8; 0.6; 0.6 | 0.828 |
Eligibility Criteria
Inclusion Criteria
- Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
- Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
- All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
- Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
- If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.
Exclusion Criteria
- Currently receiving alpha-blocker therapy for the treatment of hypertension.
- History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
- Treated with nitrates for any cardiac conditions.
- Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- Have problems with kidneys, liver, or nervous system
- Have uncontrolled diabetes
- Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
- Have had a stroke or a significant injury to brain or spinal cord.
Data sourced from ClinicalTrials.gov (NCT00848081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.