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Maintaining Suppression of Testosterone With Transdermal Estradiol Gel

NCT02349386 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-03-31

Study results available
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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.

Conditions

  • Cancer of the Prostate

Interventions

DRUG

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

An absorptive hydroalcoholic gel preparation containing 17β-estradiol.

DRUG

Placebo

An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.

Sponsors & Collaborators

  • H2O Clinical LLC

    collaborator INDUSTRY

  • Q2 Solutions

    collaborator INDUSTRY

  • BHR Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Roland Gerritsen van der Hoop, MD, PhD · BHR Pharma, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-06-14
Completion
2018-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349386 on ClinicalTrials.gov