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NCT00176644 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

A Phase 2 study, sponsored by University of Medicine and Dentistry of New Jersey.

Terminated
Registry status
Phase 2
Development phase
23
Enrollment target

NCT00176644: Clinical Trial Phase 2 study, sponsored by University of Medicine and Dentistry of New Jersey.

NCT00176644 is a Phase 2 study that was terminated before completion, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00176644, a Phase 2 study, was terminated before completion, sponsored by University of Medicine and Dentistry of New Jersey.

TERMINATED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.

Primary Outcome

PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.

Interventions

  • DRUG Transdermal Estradiol

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2005-05
Est. Completion 2008-12
Phase Phase 2

Why NCT00176644 stopped before completion

NCT00176644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Transdermal Estradiol is the first listed.

NCT00176644 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00176644 about?

NCT00176644 is a clinical study titled "Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer". Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study th...

What is the current status of trial NCT00176644?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2005-05. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00176644?

The interventions under investigation include: Transdermal Estradiol (DRUG).

Who is sponsoring clinical trial NCT00176644?

This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00176644's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00176644, the US trial registry maintained by the National Library of Medicine. NCT00176644 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.