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NCT01539317 · ClinicalTrials.gov registry record · Phase 3
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
A Phase 3 study of Breast Cancer and Menopause, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01539317 is a Phase 3 study of Breast Cancer and Menopause that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01539317, a Phase 3 study of Breast Cancer and Menopause, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.
Conditions Studied
Interventions
- DRUG Topical saline
- DRUG Topical liquid lidocaine
Study Locations (1)
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01539317
The ClinicalTrials.gov registry entry for NCT01539317 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 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 (98% lower). The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Topical saline is the first listed.
NCT01539317 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.
Frequently Asked Questions
What is clinical trial NCT01539317 about?
NCT01539317 is a clinical study titled "Therapy to Prevent Sexual Pain in Breast Cancer Survivors". The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain a...
What is the current status of trial NCT01539317?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2011-12. Estimated completion is 2013-11.
What conditions does trial NCT01539317 study?
This clinical trial studies the following conditions: Breast Cancer, Menopause, Dyspareunia, Vulvodynia.
What interventions are being tested in trial NCT01539317?
The interventions under investigation include: Topical saline (DRUG), Topical liquid lidocaine (DRUG).
Who is sponsoring clinical trial NCT01539317?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01539317 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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