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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Evaluate Recovery of Testosterone for Patients Using Eligard

Short name Eligard

Overview

Status
Completed
Phase
Phase 4
Enrollment
42 participants (actual)
Sponsor
Chesapeake Urology Research Associates · Other
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Oct 2003
Primary completion
Jun 2009
Completion
Jun 2009
First posted
3 Jun 2010 (estimated)
Last update posted
24 Oct 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200620082010
  1. Ph 4

    Eligard

    NCT01136226

    Oct 2003 to Jun 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

Interventions

  • Eligard (TM)Drug

Arms1

  • Other

    Eligard (TM)

    Eligard (TM) administered 22.5mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Serum Testosterone Recovery

    Time frame · 6 mos

    Registry description

    To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

Secondary outcomes(1)
  1. Safety Assessments

    Time frame · 6 months

    Registry description

    Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 mos

Serum Testosterone Recovery

GroupValue (Months)
Single Arm- Eligard6
Secondary and other outcome results(1)
Secondary outcome· 6 months

Safety Assessments

GroupValue
Eligard (TM)not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Single Arm- EligardEligard 22.5mg is only intervention administered–0 / 290 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 50 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Must be outpatient, not hospitalized * Male Patient between ages 50-80, inclusive * Histologically/Cytologically graded adenocarcinoma of the prostate * Must have T1, T2 or T3a adenocarcinoma of the prostate * Must be a candidate for radiation therapy. Hormone refractory patients excluded * WHO/ECOG score of 0,1 or 2 Exclusion Criteria: * NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator. * Used the following treatments for prostate Cancer \*immunotherapy \*chemotherapy \*External Beam Radiation \*brachytherapy \*hormonal therapy \*biological response modifiers * Prior Prostate Surgery (excluding TUNA or TURP) * Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs * Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer * Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect * uncontrolled CHF within 6 months to baseline * Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit * Venous thrombosis with in 6 Months of Screening * Uncontrolled Hypertension defined as \>170/100 or Symptomatic Hypotension within 3 months of Baseline * Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard. * Drug or Alcohol Abuse 6 months prior to Baseline * Other Serious Illness at the discretion of the Investigator * Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline * Hypersensitivity to GnRH, GnRH agonists

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