Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT01422408
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2011-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Patients on Endocrine Therapy for Either Breast Cancer or an Increased Risk for Breast Cancer With Symptoms of Vaginal Dryness and Dyspareunia
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
SECONDARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.
III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.
IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.
OUTLINE:
Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.
I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
SECONDARY OBJECTIVES:
I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.
III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.
IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.
OUTLINE:
Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01234 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CPC-11028-L | OTHER | OHSU Knight Cancer Institute | View | |
| 7265 | OTHER | OHSU Knight Cancer Institute | View | |
| P30CA69533OD | OTHER_GRANT | National Cancer Institute | View | |
| P30CA069533 | NIH | None | https://reporter.nih.gov/quic… | View |