Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01422408
Eligibility Criteria:
Inclusion Criteria:
* Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention
* Vaginal dryness or dyspareunia must be present for at least two months prior to study entry
* Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study
* Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream
* Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance
* Subjects must sign informed consent
* Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent
Exclusion Criteria:
* Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)
* Use of any estrogen containing medications, products, or preparations
* Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted
* Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia
* Subject reported symptoms of vaginal infection with significant vaginal discharge or odor
* Known current vaginal infection
* Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms
* Known intolerance of topical steroid preparations
* Pregnant or lactating women (to be obtained via subject report only)
* Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or Cushing's syndrome
* No prior chemotherapeutic treatment for any malignancy other than breast cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01422408
Study Brief:
Protocol Section:
NCT01422408