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NCT01376349 · ClinicalTrials.gov registry record · Phase 3

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

A Phase 3 study of Breast Cancer and Gynecologic Cancer, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
464
Enrollment target
20
Study locations

NCT01376349 is a Phase 3 study of Breast Cancer and Gynecologic Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 464 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 2 states.

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The verdict

NCT01376349, a Phase 3 study of Breast Cancer and Gynecologic Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
464 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.

Interventions

  • OTHER placebo
  • DRUG prasterone

Study Locations (20)

Colorado

  • Aurora Presbyterian Hospital - Aurora
  • Boulder Community Hospital - Boulder
  • Penrose Cancer Center at Penrose Hospital - Colorado Springs
  • St. Anthony Central Hospital - Denver
  • Porter Adventist Hospital - Denver
  • Presbyterian - St. Luke's Medical Center - Denver
  • St. Joseph Hospital - Denver
  • Rose Medical Center - Denver
  • CCOP - Colorado Cancer Research Program - Denver
  • Swedish Medical Center - Englewood
  • Poudre Valley Hospital - Fort Collins
  • Front Range Cancer Specialists - Fort Collins
  • North Colorado Medical Center - Greeley
  • Littleton Adventist Hospital - Littleton
  • Sky Ridge Medical Center - Lone Tree
  • Hope Cancer Care Center at Longmont United Hospital - Longmont
  • McKee Medical Center - Loveland
  • Parker Adventist Hospital - Parker
  • St. Mary - Corwin Regional Medical Center - Pueblo

Arizona

  • Mayo Clinic Scottsdale - Scottsdale

Trial Details

FieldValue
Enrollment Target 464 participants
Start Date 2011-07
Est. Completion 2017-11
Phase Phase 3

What the Registry Record Tells You About NCT01376349

The ClinicalTrials.gov registry entry for NCT01376349 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 464 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01376349 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Arizona.

Frequently Asked Questions

What is clinical trial NCT01376349 about?

NCT01376349 is a clinical study titled "Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms". RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.

What is the current status of trial NCT01376349?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2011-07. Estimated completion is 2017-11.

What conditions does trial NCT01376349 study?

This clinical trial studies the following conditions: Breast Cancer, Gynecologic Cancer.

What interventions are being tested in trial NCT01376349?

The interventions under investigation include: placebo (OTHER), prasterone (DRUG).

Who is sponsoring clinical trial NCT01376349?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01376349 being conducted?

This trial has 20 study locations across Arizona, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.