Back to results

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

Primary Purpose

Erectile Dysfunction, Benign Prostatic Hyperplasia

Status

Withdrawn

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Udenafil

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Prostatic Hyperplasia, Phosphodiesterase 5 inhibitors, Erectile DysfunctionDrug Therapy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Udenafil 25 mg

Udenafil 50 mg

Udenafil 75 mg

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Participants with Adverse Events

AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).

Full Information

NCT ID

NCT01967251

First Posted

October 17, 2013

Last Updated

March 3, 2016

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT01967251

Brief Title

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

Official Title

A Randomized, Triple Blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Dose Response of Udenafil for 12 Weeks in Mexican Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Withdrawn

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

The drug being tested in this study is called Udenafil. Udenafil is being tested to treat lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and for the treatment of erectile dysfunction (ED). This study will look at the change in lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and in erectile dysfunction (ED) in people who take Udenafil. The study will enroll approximately 950 patients. Participants taking BPH or ED medication will enter a 4-week wash out period. Patients not previously treated and those who accomplished the wash out period will enter a placebo (dummy inactive pill) lead-in period of another 4 weeks. Participants will then be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): Udenafil 25 mg Udenafil 50 mg Udenafil 75 mg Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take one tablet at the same time each day throughout the study, and will be asked to keep a Sexual Encounter Profile (SEP) diary. This multi-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 20 weeks. Participants will make 6 visits to the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction, Benign Prostatic Hyperplasia

Keywords

Prostatic Hyperplasia, Phosphodiesterase 5 inhibitors, Erectile DysfunctionDrug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Udenafil 25 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Udenafil 50 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Udenafil 75 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Udenafil

Intervention Description

Udenafil tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Udenafil placebo-matching tablets

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 12

Title

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

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Participants with Adverse Events

Description

AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Mexico

State/Province

Distrito Federal

Country

Mexico

City

Mexico

State/Province

Estado de México

Country

Mexico

City

Guadalajara

State/Province

Jalisco

Country

Mexico

City

Morelia

State/Province

Michoacán

Country

Mexico

City

Cuernavaca

State/Province

Morelos

Country

Mexico

City

Monterrey

State/Province

Nuevo León

Country

Mexico

City

Cholula

State/Province

Puebla

Country

Mexico

City

Chihuahua

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs