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Erectile DysfunctionPhase 2NCT01967251

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

A Phase 2 study testing Udenafil in people with Erectile Dysfunction and Benign Prostatic Hyperplasia, run by Takeda at 8 sites in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 years and older, men only
What is being tested?
Udenafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
8 sitesMexico
Study dates
Sep 2015to Sep 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Mexico8 sites

  • Study site

    Chihuahua City, Chihuahua

  • Study site

    Cholula, Puebla

  • Study site

    Cuernavaca, Morelos

  • Study site

    Guadalajara, Jalisco

  • Study site

    México, State of Mexico

  • Study site

    Mexico City, Mexico City

  • Study site

    Monterrey, Nuevo León

  • Study site

    Morelia, Michoacán

Other trials in Mexico

About this study

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

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).

Read the 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.

Being tested
Udenafil, Placebo
Keywords
Prostatic Hyperplasia, Phosphodiesterase 5 inhibitors, Erectile DysfunctionDrug Therapy
Medical subject headings
Erectile Dysfunction, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UdenafilDrug

    Udenafil tablets

  • PlaceboDrug

    Udenafil placebo-matching tablets

Study groups in NCT01967251
Study groupRoleWhat they receive
Udenafil 25 mgExperimentalUdenafil 25 mg, tablets, orally, once daily for 12 weeks.
Receives: Drug: Udenafil
Udenafil 50 mgExperimentalUdenafil 50 mg, tablets, orally, once daily for 12 weeks.
Receives: Drug: Udenafil
Udenafil 75 mgExperimentalUdenafil 75 mg, tablets, orally, once daily for 12 weeks.
Receives: Drug: Udenafil
PlaceboPlacebo comparatorUdenafil placebo-matching tablets, orally, once daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 12

  2. 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.

    Measured: Baseline and Week 12

Secondary outcomes (1)

  1. 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).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2013 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01967251
Sponsor's protocol ID
MX030
Other IDs
U1111-1146-1278
Status last verified
Mar 2016
First submitted
17 Oct 2013
Last updated
4 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Udenafil in people with Erectile Dysfunction and Benign Prostatic Hyperplasia, run by Takeda at 8 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Total International Prostate Symptom Score (IPSS) (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01967251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.

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