Maintaining Suppression of Testosterone With Transdermal Estradiol Gel

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cancer of the Prostate

In brief

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.

Key facts

Study ID

NCT02349386

Run by

BHR Pharma, LLC

People needed

34

Starts

2015-07-01

Expected to finish

2018-01-10

Last updated by the study team

2022-03-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males, Ages 18 and older
• Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive)
• Not currently hospitalized
• Clinical indication of adenocarcinoma of the prostate evidenced by a biopsy report on record
• At present receiving ADT treatment with a GnRH agonist for at least 2 months but not longer than 36 months without interruption - Note: If the patient received GnRH agonist treatment prior to the treatment described under 5, there must be evidence of a period without GnRH agonist treatment for a minimum of 2 months prior to starting the present treatment as is seen, for example with intermittent treatment regimens.
• Able to initiate Screening procedures 2 weeks prior to the next scheduled injection with a GnRH agonist
• Willing to discontinue current ADT regimen for the duration of the study
• T level less than 50 ng/dL at Screening
• WHO/ECOG performance status of 0 or 1
• Life expectancy of at least 1 year
• Adequate renal function demonstrated by having normal blood urea nitrogen (BUN) and Creatinine Screening lab values

You may not qualify if…

• History or presence of allergic or adverse response to estradiol
• Presence of symptomatic metastatic disease, risk of spinal cord compression or urinary obstruction
• History within the past 2 years of deep vein thrombosis (DVT), pulmonary embolism (PE2), a known thrombophilic disorder (eg.protein C, protein S, or antithrombin deficiency), or cerebrovascular accident (CVA)
• History within the past 2 years of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft)
• History of congestive heart failure
• Use of any investigational drug, biologic, or device within 28 days prior to the first dose of study gel
• Use of any of the following known inducers or inhibitors of cytochrome P450 3A4 (CYP3A4): phenobarbital, carbamazepine, rifampin, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, St. John's Wort preparations (Hypericum perforatum), and grapefruit juice
• Hematological parameters (Hematocrit or Hemoglobin) outside 20% of the upper or lower limits of normal at Screening
• Active skin rash, sunburn, or other skin disorder on the upper arm(s) that requires treatment or may affect skin absorption of study gel
• Resting uncontrolled hypertension (HTN) (160/100 mmHg) at Screening
• Co-existent malignancy or a history of malignancy during the past 5 years, with the exception of basal and/or squamous cell carcinoma of the skin
• Any other significant concurrent illness or disease or condition that in the opinion of the Investigator might interfere with the patient's ability to receive the treatment outlined in the protocol or might put him at additional risk

Where it is running

• 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 Township, 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

Full record on ClinicalTrials.gov

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