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Trial record 6 of 2074 for:    ESTRADIOL

Estradiol Levels in Patients Treated With Estring

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ClinicalTrials.gov Identifier: NCT01923298
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Brief 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.

Condition or disease Intervention/treatment Phase
Estrogen Levels Among Breast Cancer Patients Drug: Estradiol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Phase II Trial to Evaluate Serum Estradiol Levels in Patients With Breast Cancer Treated With Vaginal Estrogen, Estring
Actual Study Start Date : August 9, 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : April 24, 2019


Arm Intervention/treatment
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.
Drug: Estradiol



Primary Outcome Measures :
  1. Serum Estradiol [ Time Frame: Baseline:4wk:12:wk:16wk ]
    To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring


Secondary Outcome Measures :
  1. Vaginal Dryness [ Time Frame: Baseline: 16 Week ]
    To measure changes in vaginal dryness symptom questionnaire compared to their baseline while on treatment with Estring



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923298


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85742
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Pavani Chalasani University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01923298     History of Changes
Other Study ID Numbers: 13-0477-04
EString ( Other Identifier: The University of Arizona Cancer Center )
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female