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Maintaining Suppression of Testosterone With Transdermal Estradiol Gel (MASTERS)

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ClinicalTrials.gov Identifier: NCT02349386
Recruitment Status : Terminated (Inability to recruit patients)
First Posted : January 28, 2015
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
H2O Clinical LLC
Q2 Solutions
Information provided by (Responsible Party):
BHR Pharma, LLC

January 23, 2015
January 28, 2015
April 4, 2018
July 2015
June 14, 2017   (Final data collection date for primary outcome measure)
testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12. [ Time Frame: Week 12 ]
Same as current
Complete list of historical versions of study NCT02349386 on ClinicalTrials.gov Archive Site
  • testosterone suppression, defined as the absence of any T level over 50 ng/dL during Weeks 4-24. [ Time Frame: Week 24 ]
  • Incidence and severity of adverse events with special attention given to thromboembolic events. [ Time Frame: Week 24 ]
  • Serum concentrations of: follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone binding globulin (SHBG), and prostate-specific antigen (PSA). [ Time Frame: Week 24 ]
Same as current
Not Provided
Not Provided
 
Maintaining Suppression of Testosterone With Transdermal Estradiol Gel
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cancer of the Prostate
  • Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
    An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
    Other Name: BHR-200
  • Drug: Placebo
    An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
  • Experimental: BHR-200 Low Dose
    3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
    Intervention: Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
  • Experimental: BHR-200 Mid Dose
    6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
    Intervention: Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
  • Experimental: BHR-200 High Dose
    9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks.
    Intervention: Drug: BHR-200 (0.36% transdermal 17β-estradiol gel)
  • Placebo Comparator: Placebo
    1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
120
January 10, 2018
June 14, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males, Ages 18 and older
  2. Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive)
  3. Not currently hospitalized
  4. Clinical indication of adenocarcinoma of the prostate evidenced by a biopsy report on record
  5. 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.
  6. Able to initiate Screening procedures 2 weeks prior to the next scheduled injection with a GnRH agonist
  7. Willing to discontinue current ADT regimen for the duration of the study
  8. T level less than 50 ng/dL at Screening
  9. WHO/ECOG performance status of 0 or 1
  10. Life expectancy of at least 1 year
  11. Adequate renal function demonstrated by having normal blood urea nitrogen (BUN) and Creatinine Screening lab values

Exclusion Criteria:

  1. History or presence of allergic or adverse response to estradiol
  2. Presence of symptomatic metastatic disease, risk of spinal cord compression or urinary obstruction
  3. 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)
  4. History within the past 2 years of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft)
  5. History of congestive heart failure
  6. Use of any investigational drug, biologic, or device within 28 days prior to the first dose of study gel
  7. 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
  8. Hematological parameters (Hematocrit or Hemoglobin) outside 20% of the upper or lower limits of normal at Screening
  9. Active skin rash, sunburn, or other skin disorder on the upper arm(s) that requires treatment or may affect skin absorption of study gel
  10. Resting uncontrolled hypertension (HTN) (160/100 mmHg) at Screening
  11. 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
  12. 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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02349386
BHR-200-201
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
BHR Pharma, LLC
BHR Pharma, LLC
  • H2O Clinical LLC
  • Q2 Solutions
Study Director: Roland Gerritsen van der Hoop, MD, PhD BHR Pharma, LLC
BHR Pharma, LLC
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP