Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Breast Cancer and Gynecologic Cancer, sponsored by Alliance for Clinical Trials in Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported s
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2011-07 |
| Est. Completion | 2017-11 |
| Phase | Phase 3 |
What the finished NCT01376349 record still lists
NCT01376349 is an interventional study that assigns participants to a tested intervention. The registered 464 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower).
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 names 20 study sites across 2 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01376349's enrollment target sits among peer trials
464 211th of 1224 higher than 1,014 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
RECRUITING · Phase 3
-
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
RECRUITING · Phase 3
-
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
RECRUITING · Phase 3
-
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
RECRUITING · Phase 3
-
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04787744 · 464 participants · Phase 2
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
- NCT04855656 · 464 participants · Phase 1
Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
- NCT06283927 · 464 participants
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
- NCT06444295 · 464 participants · NA
Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia