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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: Completed Phase 2 study, sponsored by University of Arizona.
NCT01923298 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring
Interventions
- DRUG Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-08-09 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 2 |
What the finished NCT01923298 record still lists
NCT01923298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Estradiol is the first listed.
NCT01923298 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01923298's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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