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Completed

NCT Number: NCT00783094

Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
  • Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
  • Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.

Exclusion criteria

  • Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
  • History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
  • History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
  • Clinical evidence of prostate cancer at Visit 1.
  • Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
  • History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
  • History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
  • Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.

Treatment and study plan

Tadalafil 2.5 mg

Drug

oral, daily

Other names: LY450190, Cialis

Tadalafil 5 mg

Drug

oral, daily

Other names: LY450190, Cialis

Placebo

Drug

oral, daily

Primary outcomes

  1. Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Secondary outcomes

  1. Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.

  2. Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.

  3. Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).

  4. Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.

  5. Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).

  6. Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement

    Time frame: Baseline, 12 weeks

    Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.

  7. Number of Participants With Adverse Events During 12 Weeks of the Study

    Time frame: Baseline through 12 weeks

    A listing of Adverse Events are reported in the Reported Adverse Event Section.

  8. Change From Baseline in Blood Pressure at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

  9. Change From Baseline in Sitting Heart Rate at 12-Week Endpoint

    Time frame: Baseline, 12 Weeks

  10. Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.

  11. Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint

    Time frame: Baseline, 12 weeks

    Measurement of nanograms of PSA per milliliter (ng/mL) of blood.

  12. Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

  13. Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.

  14. Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.

  15. Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).

  16. Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.

  17. Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).

  18. Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment

    Time frame: End of 12 weeks of double-blind through 54 weeks

    A listing of Adverse Events are reported in the Reported Adverse Event Section.

  19. Change From Baseline in Blood Pressure During at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

  20. Change From Baseline in Sitting Heart Rate at 54-Week Endpoint

    Time frame: Baseline, 54-weeks

  21. Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    Measurement of nanograms of PSA per milliliter (ng/mL) of blood.

  22. Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint

    Time frame: Baseline, 54 weeks

    Post residual volume (PVR) is measured by ultrasound at regular intervals.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 31, 2008
Registry last updated
Mar 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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