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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: Completed Phase 3 study of Breast Cancer and Menopause, sponsored by OHSU Knight Cancer Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being "no pain" and 10 being "worst possible pain"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Ratin
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 |
What the finished NCT01539317 record still lists
NCT01539317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
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 NCT01539317's enrollment target sits among peer trials
50 789th of 1224 higher than 410 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.
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