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NCT01422408 · ClinicalTrials.gov registry record · Phase 2
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01422408: Completed Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT01422408 is a Phase 2 study that has completed, run by OHSU Knight Cancer Institute. 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.
The verdict
NCT01422408, a Phase 2 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.
Primary Outcome
Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-
Interventions
- OTHER Questionnaire Administration
- PROCEDURE Management of Therapy Complications
- DRUG Fluocinonide Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01422408 record still lists
NCT01422408 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 3 interventions - of which Questionnaire Administration is the first listed.
NCT01422408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01422408 about?
NCT01422408 is a clinical study titled "Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy". This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients u...
What is the current status of trial NCT01422408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2011-09. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01422408?
The interventions under investigation include: Questionnaire Administration (OTHER), Management of Therapy Complications (PROCEDURE), Fluocinonide Cream (DRUG).
Who is sponsoring clinical trial NCT01422408?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01422408'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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