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Hyperplasia clinical trials

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NCT ID: NCT01338623 Recruiting - Clinical trials for Hyperplasia Prostatic

Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State

BET04cap
Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the bioavailability (rate and extent of absorption) of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover study with a seven-days washout interval was conduced in 32 healthy male volunteers. The plasma samples were obtained up to 72 hours after drug administration. A sensitive and specific LC-MS/MS method was developed and validated for the determination of tansulosine in human plasma. Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.

NCT ID: NCT01337258 Completed - Cancer Clinical Trials

Economic Analyses of the REDUCE Trial

Start date: January 2010
Phase: N/A
Study type: Observational

The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment. The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.

NCT ID: NCT01334723 Completed - Clinical trials for Prostatic Hyperplasia

Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Start date: April 2010
Phase: N/A
Study type: Observational

This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).

NCT ID: NCT01332487 Completed - Clinical trials for Prostatic Hyperplasia

Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

Start date: August 2010
Phase: N/A
Study type: Observational

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).

NCT ID: NCT01332435 Completed - Clinical trials for Prostatic Hyperplasia

Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Start date: November 2009
Phase: N/A
Study type: Observational

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).

NCT ID: NCT01330303 Completed - Healthy Volunteers Clinical Trials

SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin

Start date: December 2009
Phase: Phase 1
Study type: Interventional

It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.

NCT ID: NCT01329458 Recruiting - Liver Metastases Clinical Trials

Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions

HepFocUS
Start date: December 2010
Phase: N/A
Study type: Observational

The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.

NCT ID: NCT01323998 Completed - Clinical trials for Prostatic Hyperplasia

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Start date: April 2010
Phase: N/A
Study type: Observational

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

NCT ID: NCT01314456 Not yet recruiting - Prostate Cancer Clinical Trials

3D Recording of a Trans-rectal Prostate Biopsy

Start date: March 2011
Phase: N/A
Study type: Interventional

Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the prostate gland under a trans-rectal ultrasound probe guidance. Today, the performing physician navigates the needle using a momentary 2D ultrasound image (longitudinal and transverse B mode) without any record of the full prostate boundaries or previous biopsies' location. This study's Objectives are to record the trans-rectal biopsy procedure including the initial scan and the needle biopsy location and to modulate a 3D model of the prostate with accurate display the locations of the various biopsies taken during the procedure.

NCT ID: NCT01313455 Completed - Obesity Clinical Trials

Adrenal Hyperplasia Among Young People With PCOS

Start date: March 10, 2011
Phase:
Study type: Observational

Background: - Polycystic ovarian syndrome (PCOS) is a group of disorders related to problems with the secretion of certain hormones, which can lead to reproductive and other issues in women. Frequent complications of PCOS include irregular menstruation, development of ovarian cysts, and insulin resistance. The adrenal glands, which sit on top of the kidney, are involved in the production of certain hormones and the regulation of steroid levels in the blood, and may be affected in women with PCOS. Researchers are interested in studying possible connections between the adrenal glands and PCOS in young women who have been diagnosed with PCOS and healthy volunteers with normal menstrual function. Objectives: - To investigate possible connections between adrenal gland steroid hormone secretion and polycystic ovarian syndrome. Eligibility: - Women between 16 and 29 years of age who have been diagnosed with PCOS, or who are healthy volunteers with normal menstrual function. - Participants must be willing to discontinue the use of oral contraceptives or any other medications that alter steroid hormone production for at least 1 month before the start of the study. Design: - Participants will be screened with a physical examination, medical history, and blood and urine tests. All participants will also have a pelvic (ovarian) ultrasound. - All participants will be admitted to the hospital for a 1-week testing period, which will involve the following tests: - Regular blood draws for two 2-hour periods (late evening and early morning) to measure hormone levels - Fasting blood draws with a dose of corticotropin to test the body's adrenal function - Hormone level measurement following regular doses of dexamethasone (a drug that controls the function of the adrenal gland) - Daily urine collection for 6 days. - Other studies, such as imaging studies of the adrenal glands, may be conducted as required by the study researchers.