We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

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.
ClinicalTrials.gov Identifier: NCT01351987
Recruitment Status : Unknown
Verified May 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital

Brief Summary:
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.

Condition or disease
Benign Prostatic Hyperplasia

Detailed Description:
This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.

Study Type : Observational
Estimated Enrollment : 855 participants
Observational Model: Case-Only
Official Title: An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
Study Start Date : December 2010
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources





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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Benign Prostatic Hyperplasia male paitents
Criteria

Inclusion Criteria:

  • Males, age ≧ 50 years
  • Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
  • IPSS score ≧ 8 points and prostate volume ≧ 30 mL
  • Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening
  • Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.
  • Dutasteride combination therapy will be allowed by investigator's prescription
  • Ability to understand and willingly provide written informed consent

Exclusion Criteria:

  • History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)
  • With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study
  • Use of finasteride within 6 months of screening visit
  • Use of dutasteride within 12 months of 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 ClinicalTrials.gov identifier (NCT number): NCT01351987


Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Liang-Ming Lee Taipei Medical University WanFang Hospital

Responsible Party: Liang-Ming Lee, Superintendent Office, Wanfang Hospital
ClinicalTrials.gov Identifier: NCT01351987     History of Changes
Other Study ID Numbers: 100006
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
Adrenergic alpha-Antagonists
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents