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NCT02349386 · ClinicalTrials.gov registry record · Phase 2

Maintaining Suppression of Testosterone With Transdermal Estradiol Gel

A Phase 2 study, sponsored by BHR Pharma.

Terminated
Registry status
Phase 2
Development phase
34
Enrollment target

NCT02349386: Clinical Trial Phase 2 study, sponsored by BHR Pharma.

NCT02349386 is a Phase 2 study that was terminated before completion, run by BHR Pharma. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02349386, a Phase 2 study, was terminated before completion, sponsored by BHR Pharma.

TERMINATED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2015-07
Est. Completion 2018-01-10
Phase Phase 2
BHR Pharma

3 total trials

Why NCT02349386 stopped before completion

NCT02349386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02349386 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02349386 about?

NCT02349386 is a clinical study titled "Maintaining Suppression of Testosterone With Transdermal Estradiol Gel". 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.

What is the current status of trial NCT02349386?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2015-07. Estimated completion is 2018-01-10.

What interventions are being tested in trial NCT02349386?

The interventions under investigation include: Placebo (DRUG), BHR-200 (0.36% transdermal 17β-estradiol gel) (DRUG).

Who is sponsoring clinical trial NCT02349386?

This trial is sponsored by BHR Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02349386's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 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 NCT02349386, the US trial registry maintained by the National Library of Medicine. NCT02349386 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.