Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00547625
Other study ID # 9120
Secondary ID H6D-MC-LVGC
Status Completed
Phase Phase 2
First received October 18, 2007
Last updated October 18, 2007
Start date October 2004
Est. completion date July 2005

Study information

Verified date October 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.


Recruitment information / eligibility

Status Completed
Enrollment 275
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria:

- 6 month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist.

- Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study.

- Meet required prostate symptom score and urine flow rate.

Exclusion Criteria:

- Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months.

- Prostate removal and various other pelvic surgeries.

- Neurological disease or condition known to affect the bladder.

- Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis.

- Have taken medications such as nitrates, finasteride, or dutasteride within the year.

Study Design

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


Intervention

Drug:
tadalafil
Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.
placebo
Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Locations

Country Name City State
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company ICOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Prostate Symptom Score (IPSS) sum total of questions 1-7 6 and 12 weeks
Secondary Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII. 12 weeks
Secondary Measure Uroflowmetry parameters 12 weeks
Secondary Evaluate safety by PSA levels and postvoid residual volume (PVR) 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02578953 - Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects Phase 1
Terminated NCT02396420 - Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams Phase 2
Terminated NCT04398966 - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT02947958 - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia N/A
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT00427882 - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study Phase 4
Completed NCT02244320 - Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin) N/A
Completed NCT01254071 - A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. Phase 1
Recruiting NCT04108871 - Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men N/A
Recruiting NCT05686525 - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH N/A
Completed NCT01957189 - This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples Phase 1
Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
Completed NCT02715401 - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers Phase 1
Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
Completed NCT01482676 - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction N/A
Completed NCT00822952 - Prostate Mechanical Imager (PMI) Clinical Bridging Study N/A
Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00563485 - Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A

External Links