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NCT01923298 · ClinicalTrials.gov registry record · Phase 2
Estradiol Levels in Patients Treated With Estring
A Phase 2 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01923298 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 14 participants.
The verdict
NCT01923298, a Phase 2 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Estrogen receptor positive breast cancer is the most common type of breast cancer and anti-estrogen therapy has been shown to be very effective in preventing recurrence. Side effects of anti-estrogens are due to estrogen deprivation and include hot flashes, mood changes and vaginal dryness/pain. Vaginal symptoms including pain, dryness, itching, bleeding after intercourse and frequent urinary tract infections have been reported to cause significant morbidity in postmenopausal women and higher in breast cancer survivors on anti-estrogen therapy. Treatment options include vaginal lubricants, Replens etc but unfortunately many women continue to have persistent symptoms. Local estrogen has been shown to be effective in post menopausal women (Estring or Vagifem) for their vaginal symptoms. There is a concern of using this in women with breast cancer given it may increase their blood estrogen levels. Studies done so far show have shown controversial results but majority of them report that blood estrogen levels do not change significantly. The major drawback of the studies was the sample size and inadequate accrual. The most recent trial reported showed no significant change in blood estrogen levels in women with breast cancer treated with aromatase inhibitors (anti-estrogen therapy) and were on vagifem for their vaginal symptoms. The authors reported results in 26 patients and reported no significant change in blood estrogen level. We propose to study the change in blood estrogen level when postmenopausal women with breast cancer who are currently on aromatase inhibitors are treated with Estring for their vaginal symptoms.
Interventions
- DRUG Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-08-09 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01923298
The ClinicalTrials.gov registry entry for NCT01923298 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Estradiol is the first listed.
NCT01923298 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01923298 about?
NCT01923298 is a clinical study titled "Estradiol Levels in Patients Treated With Estring". Estrogen receptor positive breast cancer is the most common type of breast cancer and anti-estrogen therapy has been shown to be very effective in preventing recurrence. Side effects of anti-estrogens are due to estrogen deprivation and include hot flashes, mood changes and vaginal dryness/pain. Vag...
What is the current status of trial NCT01923298?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2013-08-09. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT01923298?
The interventions under investigation include: Estradiol (DRUG).
Who is sponsoring clinical trial NCT01923298?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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