Who is sponsoring MASTERS?

MASTERS is sponsored by BHR Pharma, LLC.

What condition does MASTERS study?

MASTERS studies Cancer of the Prostate.

What drugs are being tested in MASTERS?

Interventions: BHR-200 (0.36% transdermal 17β-estradiol gel), Placebo.

What is the status of MASTERS?

MASTERS is currently TERMINATED.

Last reviewed 2022-03-08 · How we verify

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 (MASTERS)

NCT02349386 Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	BHR Pharma, LLC
Phase	Phase 2
Status	TERMINATED
Enrolment	34
Start date	2015-07
Completion	2018-01-10

Conditions

Cancer of the Prostate

Interventions

BHR-200 (0.36% transdermal 17β-estradiol gel)
Placebo

Primary outcomes

Maintenance of Testosterone Suppression at Week 12 — Week 12
Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T \< 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12.

Countries

United States