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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01967251
Recruitment Status : Withdrawn
First Posted : October 22, 2013
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Benign Prostatic Hyperplasia Drug: Udenafil Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from Baseline in Total International Prostate Symptom Score (IPSS) [ Time Frame: Baseline to Week 12 ]
    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.

  2. Change from Baseline in Erectile Function Domain of the International Index of Erectile Function (IIEF) [ Time Frame: Baseline and Week 12 ]
    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 :
  1. Participants with Adverse Events [ Time Frame: 12 weeks ]
    AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01967251

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Mexico, Distrito Federal, Mexico
Mexico, Estado de México, Mexico
Guadalajara, Jalisco, Mexico
Morelia, Michoacán, Mexico
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo León, Mexico
Cholula, Puebla, Mexico
Chihuahua, Mexico
Sponsors and Collaborators
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Study Director: Medical Director Takeda
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Responsible Party: Takeda Identifier: NCT01967251    
Other Study ID Numbers: MX030
U1111-1146-1278 ( Other Identifier: World Health Organization )
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Takeda:
Prostatic Hyperplasia
Phosphodiesterase 5 inhibitors
Erectile DysfunctionDrug Therapy
Additional relevant MeSH terms:
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Erectile Dysfunction
Prostatic Hyperplasia
Pathologic Processes
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Prostatic Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action