Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction

NCT01967251 | Withdrawn Phase 2

• 2 other identifiers: MX030U1111-1146-1278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the efficacy, dose-response and safety of udenafil 25 mg, 50 mg and 75 mg every day (q.d.) for 12 weeks in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH and for the treatment of erectile dysfunction (ED).

Conditions

Erectile Dysfunction; Benign Prostatic Hyperplasia

Keywords

Prostatic Hyperplasia; Phosphodiesterase 5 inhibitors; Erectile DysfunctionDrug Therapy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Total International Prostate Symptom Score (IPSS)

  The IPSS is an 8 question (7 symptom questions + 1 quality of life question) tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The 7 symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 1 to 5 for a total of maximum 35 points. The 8th question of quality of life is assigned a score of 1 to 6. The total score correlates as follows: 0-7 mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.

  Baseline to Week 12

• Change from Baseline in Erectile Function Domain of the International Index of Erectile Function (IIEF)

  The IIEF is a standardised and validated 15-item self-evaluation scale that provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction. The Erectile Function domain (6-item) provides pre-post treatment evaluations of erectile function.

  Baseline and Week 12

Secondary Outcomes (1)

• Participants with Adverse Events

  12 weeks

Study Arms (4)

Udenafil 25 mg

EXPERIMENTAL

Udenafil 25 mg, tablets, orally, once daily for 12 weeks.

Drug: Udenafil

Udenafil 50 mg

EXPERIMENTAL

Udenafil 50 mg, tablets, orally, once daily for 12 weeks.

Drug: Udenafil

Udenafil 75 mg

EXPERIMENTAL

Udenafil 75 mg, tablets, orally, once daily for 12 weeks.

Drug: Udenafil

Placebo

PLACEBO COMPARATOR

Udenafil placebo-matching tablets, orally, once daily for 12 weeks.

Drug: Placebo

Interventions

Udenafil DRUG

Udenafil tablets

Udenafil 25 mg; Udenafil 50 mg; Udenafil 75 mg

Placebo DRUG

Udenafil placebo-matching tablets

Placebo

Eligibility Criteria

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

You may qualify if:

• Men ≥ 45 years of age.
• Sexually active, with a stable female partner with whom the participant expects to have a relationship for the entire duration of the study.
• The participant has benign prostatic hyperplasia with lower urinary tract symptoms (BPH-LUTS) according to clinical diagnostic criteria, with ≥ 6 months of evolution at the screening visit.
• Clinical history of erectile dysfunction (ED) (defined as the inability to achieve or maintain the penile erection to achieve a satisfactory sexual relationship) of at least 3 months of evolution.
• Freely given informed consent at the screening visit (an essential requirement to participate in the study).
• Bladder obstruction defined by maximal flow rate (Qmax) of 4-15 mI/sec (with a premicturition volume of 150 to 550 mL evaluated by ultrasound, with a minimum micturition volume of 125 mL) at Visit I immediately prior to active treatment initiation.
• Total score of ≥ 13 points in the InternationaI Prostate Symptom Score (IPSS) questionnaire at Visit 1, immediately prior to active treatment initiation.

You may not qualify if:

• Participants that are currently taking nitrates, antiandrogens, estrogens, luteninizing hormone-releasing hormone agonist/antagonist, or anabolic steroids at study entry. Participants that are taking a stable dose level of testosterone are not excluded.
• Post-void residual (PVR) volume ≥ 300 mL, as assessed by ultrasound at the Visit 1.
• Prostate-specific antigen (PSA) ≥ 10.0 ng/mL at the Visit 1.
• PSA of 4.0 - 10.0 ng/ml if free PSA is \< 0,25 (25%) at Visit 1.
• Clinical evidence of prostate cancer.
• Glycosylated hemoglobin (Hb1Ac) \> 10 % at study entry.
• Patients who have undergone bladder catheterization due to acute urine retention.
• Medical history or clinical evidence of any pelvic, bladder or urinary tract condition, or urinary retention that, as judged by the urologist, might compromise protocol compliance.
• Any surgical procedure in the lower urinary tract (including prostate biopsy) within 30 days prior to the Screening Visit.

Sponsors & Collaborators

• Takeda: lead

Study Sites (8)

Unknown Facility

Chihuahua City, Chihuahua, Mexico

Location

Unknown Facility

Guadalajara, Jalisco, Mexico

Location

Unknown Facility

Mexico City, Mexico City, Mexico

Location

Unknown Facility

Morelia, Michoacán, Mexico

Location

Unknown Facility

Cuernavaca, Morelos, Mexico

Location

Unknown Facility

Monterrey, Nuevo León, Mexico

Location

Unknown Facility

Cholula, Puebla, Mexico

Location

Unknown Facility

México, State of Mexico, Mexico

Location

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Hyperplasia

Interventions

udenafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Prostatic Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 22, 2013
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

ME (8)