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

This study is not yet open for participant recruitment.
Verified October 2013 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01967251
First received: October 17, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Erectile Dysfunction
Benign Prostatic Hyperplasia
Drug: Udenafil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change from Baseline in Total International Prostate Symptom Score (IPSS) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).


Estimated Enrollment: 950
Study Start Date: November 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Udenafil 25 mg
Udenafil 25 mg, tablets, orally, once daily for 12 weeks.
Drug: Udenafil
Udenafil tablets
Experimental: Udenafil 50 mg
Udenafil 50 mg, tablets, orally, once daily for 12 weeks.
Drug: Udenafil
Udenafil tablets
Experimental: Udenafil 75 mg
Udenafil 75 mg, tablets, orally, once daily for 12 weeks.
Drug: Udenafil
Udenafil tablets
Placebo Comparator: Placebo
Udenafil placebo-matching tablets, orally, once daily for 12 weeks.
Drug: Placebo
Udenafil placebo-matching tablets

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men ≥ 45 years of age.
  2. Sexually active, with a stable female partner with whom the participant expects to have a relationship for the entire duration of the study.
  3. 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.
  4. 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.
  5. Freely given informed consent at the screening visit (an essential requirement to participate in the study).
  6. 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.
  7. Total score of ≥ 13 points in the InternationaI Prostate Symptom Score (IPSS) questionnaire at Visit 1, immediately prior to active treatment initiation.

Exclusion Criteria:

  1. 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.
  2. Post-void residual (PVR) volume ≥ 300 mL, as assessed by ultrasound at the Visit 1.
  3. Prostate-specific antigen (PSA) ≥ 10.0 ng/mL at the Visit 1.
  4. PSA of 4.0 - 10.0 ng/ml if free PSA is < 0,25 (25%) at Visit 1.
  5. Clinical evidence of prostate cancer.
  6. Glycosylated hemoglobin (Hb1Ac) > 10 % at study entry.
  7. Patients who have undergone bladder catheterization due to acute urine retention.
  8. 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.
  9. Any surgical procedure in the lower urinary tract (including prostate biopsy) within 30 days prior to the Screening Visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967251

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01967251     History of Changes
Other Study ID Numbers: MX030, U1111-1146-1278
Study First Received: October 17, 2013
Last Updated: October 17, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Takeda:
Prostatic Hyperplasia
Phosphodiesterase 5 inhibitors
Erectile DysfunctionDrug Therapy

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014