- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01923298
Estradiol Levels in Patients Treated With Estring
February 3, 2022 updated by: University of Arizona
A Single-arm Phase II Trial to Evaluate Serum Estradiol Levels in Patients With Breast Cancer Treated With Vaginal Estrogen, 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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85742
- University of Arizona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage I-III estrogen receptor positive breast cancer (positive for estrogen receptor (ER)) with positivity defined as immunohistochemical staining in ≥ 10% of cells) on adjuvant hormonal therapy with aromatase inhibitors (anastrozole, letrozole or exemestane)
- Adults over 18 years of age with a life expectancy of at least 3 months
- Attained menopause as defined by World Health Organization Criteria (defined as permanent cessation of menstruation resulting from the loss of ovarian follicular activity. This is recognized to occur after 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause.)
- Persistent genitourinary symptoms causing discomfort for more than 2 weeks prior to the visit with the physician.
- Tried at least 1 prior pharmacological/ non-pharmacological treatment for their genitourinary symptoms
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to any study specific procedures
- Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory tests and other study procedures
Exclusion Criteria:
- Patients with metastatic breast cancer
- Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
- Patients with vaginal stenosis
- Patients unable to apply Estring
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Estradiol
ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol.
Estradiol, silicone polymers and barium sulfate are combined to form the ring.
When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Serum Estradiol
Time Frame: Baseline, 16 weeks
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To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring
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Baseline, 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 9, 2013
Primary Completion (ACTUAL)
June 30, 2018
Study Completion (ACTUAL)
April 24, 2019
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
August 13, 2013
First Posted (ESTIMATE)
August 15, 2013
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2022
Last Update Submitted That Met QC Criteria
February 3, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0477-04
- EString (OTHER: The University of Arizona Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)TerminatedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor Negative | Estrogen Receptor Positive | HER2/Neu Negative | HER2/Neu Positive | Progesterone Receptor Negative | Progesterone Receptor Positive and other conditionsUnited States
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Cairo UniversityUnknownBreast Cancer | Metastatic Breast Cancer | Estrogen Receptor-positive Breast CancerEgypt
Clinical Trials on Estradiol
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University of HelsinkiPäivikki and Sakari Sohlberg Foundation, Finland; Finnish Medical Foundation; Emil Aaltonen FoundationCompletedCardiovascular Disease | Postmenopausal Vasomotor SymptomsFinland
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Mayo ClinicCompletedCardiovascular Risk ReductionUnited States
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Novo Nordisk A/SCompletedMenopause | Postmenopausal Vaginal AtrophyGermany
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Wake Forest University Health SciencesRecruitingRecurrent Urinary Tract InfectionUnited States
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Oregon Health and Science UniversityCompleted
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Novo Nordisk A/SCompletedMenopause | Postmenopausal Vaginal Atrophy
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Mahidol UniversityCompletedOvulation InhibitionThailand