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Spots Global Cancer Trial Database for Maintaining Suppression of Testosterone With Transdermal Estradiol Gel

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Trial Identification

Brief Title: Maintaining Suppression of Testosterone With Transdermal Estradiol Gel

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of BHR-200 (0.36% Transdermal Estradiol Gel) for the Maintenance of Testosterone Suppression in Men With Advanced Androgen-Sensitive Prostate Cancer

Study ID: NCT02349386

Study Description

Brief Summary: The objective of this clinical study is to evaluate the safety and efficacy of three different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate cancer.

Detailed Description: This is a multi-center, randomized, double-blind, placebo-controlled, dose finding study in men with advanced androgen-sensitive prostate cancer. Patients who give informed consent will have screening evaluations, and if fulfilling the entry criteria, will be randomized to one of 4 treatment groups: 1mL, 2mL or 3mL of 0.36% BHR-200 (transdermal estradiol gel) or Placebo. Study drug will be initiated on the day they were scheduled to receive next depot GnRH agonist injection. Patients will be offered low-dose radiation to aid in the prevention of gynecomastia. Patients will apply the study drug once per day. The first dose of study gel will be applied under the supervision of the PI/designee. Subsequent doses will be self-administered daily by the patient until he is no longer chemically castrated (testosterone levels increase above 50 ng/dL), a rise over baseline PSA of \> 0.5 ng/mL is observed, or he has completed 52 weeks of study drug administration. At the conclusion of study participation, patients will be advised to resume standard of care treatment under the supervision of their healthcare provider. While on treatment, patients will be evaluated at Day 1 and every 2 weeks, for the first 24 weeks and every 4 weeks thereafter with a final post-treatment follow-up visit 2 weeks (+/- 1 week) post last dose administration.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Urological Associates of Southern Arizona, Tucson, Arizona, United States

South Florida Medical Research, Aventura, Florida, United States

Advanced Urology Institute, Daytona Beach, Florida, United States

Adult Pediatric Urology, PC, Council Bluffs, Iowa, United States

Adult Pediatric Urology, PC, Omaha, Nebraska, United States

Delaware Valley Urology, Voorhees, New Jersey, United States

AccumetRX Clinical Trials, Albuquerque, New Mexico, United States

Associated Medical Professionals of NY (AMP of NY), Syracuse, New York, United States

Eastern Urological Associates, Greenville, North Carolina, United States

Urologic Consultants of Southeastern Pennsylvania (UCSEPA), Bala-Cynwyd, Pennsylvania, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States

Urology Clinics of North Texas, Dallas, Texas, United States

Contact Details

Name: Roland Gerritsen van der Hoop, MD, PhD

Affiliation: BHR Pharma, LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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