A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).

NCT02431754 | Completed Phase 4 Results

• 2 other identifiers: 15734H6D-JE-LVJK
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 9

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)

  TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.

  Week 20

Secondary Outcomes (6)

• Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score

  Baseline, Week 8

• Change From Baseline on the IPSS Storage (Irritative) Subscore

  Baseline,Week 8

• Change From Baseline on the IPSS Voiding (Obstructive) Subscore

  Baseline, Week 8

• Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )

  Baseline, Week 8

• Percentage of Participants With Global Impression of Improvement (PGI-I)

  Week 8

Study Arms (2)

Tadalafil

EXPERIMENTAL

5 milligrams (mg) tadalafil administered once daily orally for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily. Participants will remain on stable dose of alpha1 blocker through both treatment periods.

Drug: Tadalafil; Drug: Alpha1 Blocker

Placebo

PLACEBO COMPARATOR

Placebo administered once daily orally for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily. Participants will remain on stable dose of alpha1 blocker through both treatment periods.

Drug: Placebo; Drug: Alpha1 Blocker

Interventions

Tadalafil DRUG

Administered orally

Also known as: LY450190

Tadalafil

Placebo DRUG

Administered orally

Placebo

Alpha1 Blocker DRUG

Administered orally

Placebo; Tadalafil

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic criteria, at study entry.
• Have been treated with a stable dose of an alpha1 blocker (tamsulosin 0.2 mg once daily or silodosin 4 mg twice daily) for at least 8 weeks prior to screening, and continue the same alpha1 blocker at the same dose for the entire duration of the study.
• Are Japanese men.
• Have prostate volume ≥20 milliliters (mL) estimated by transabdominal or transrectal ultrasound at screening.
• Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥12 at screening and baseline.
• Have moderate LUTS with urinary peak flow rate (Qmax) ≥4 to ≤15 mL/second at baseline, while meeting both of the following criteria:
• Prevoid total bladder volume ≥150 to ≤550 mL as assessed by ultrasound
• Minimum voided volume ≥125 mL
• Demonstrate ≥80% compliance with alpha1 blocker treatment\* during the screening period, documented at baseline
• \*Tamsulosin: (Number of doses taken / Number of days to be treated) × 100
• Silodosin: (Number of doses taken / Number of days to be treated) × 50

You may not qualify if:

• Prostate-specific antigen (PSA) \>10.0 nanograms (ng)/mL at screening.
• PSA ≥4.0 to ≤10.0 ng/mL at screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
• Bladder post-void residual (PVR) ≥150 mL by ultrasound determination at screening.
• History of any of the following pelvic conditions:
• Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection
• Pelvic radiotherapy
• Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery
• Lower urinary tract malignancy or trauma
• Lower urinary tract instrumentation (including prostate biopsy) within 30 days of screening.
• History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening.
• History of urethral obstruction due to stricture, valves, sclerosis, or tumor at screening.
• History of any of the following treatments within the indicated duration:
• Antiandrogens within 11 months before screening
• Dutasteride within 5 months before screening
• Finasteride within 2 months before screening

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Nippon Shinyaku Co., Ltd.: collaborator

Study Sites (9)

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.

Kyoto, 604-8436, Japan

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.

Maebashi, 371-0805, Japan

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.

Osaka, 542-0073, Japan

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.

Sagamihara, 252-0303, Japan

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.

Sakai, 590-0024, Japan

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.

Suita, 565-0874, Japan

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.

Takasaki, 370-0826, Japan

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.

Takatsuki, 569-1115, Japan

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.

Tokyo, 132-0011, Japan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil; Adrenergic alpha-1 Receptor Antagonists

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 2, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-06

Locations

JP (9)