Estradiol Levels in Patients Treated With Estring

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT01923298
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 68.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• 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: Aug 9, 2013
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Apr 24, 2019

Arms and Interventions

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; Other Names: ESTRING®

Outcome Measures

Primary Outcome Measures

1. Changes in Serum Estradiol [Baseline, 16 weeks]

   To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85742

Sponsors and Collaborators

• University of Arizona

Investigators

• Principal Investigator: Pavani Chalasani, University of Arizona

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 14, 2018

More Information

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT01923298
• Other Study ID Numbers: 13-0477-04; EString
• First Posted: Aug 15, 2013
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Estradiol

Study Results

Participant Flow

Arm/Group Title	Estradiol
Arm/Group Description	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.
Period Title: Overall Study
STARTED	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Estradiol
Arm/Group Description	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.
Overall Participants	14
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55
Sex: Female, Male (Count of Participants)
Female	14 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	11 78.6%
Unknown or Not Reported	3 21.4%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Serum Estradiol
Description	To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Eligible patients were 18 years or older, diagnosed with HR-positive breast cancer defined as > 1% of tumor cells expressing estrogen or progesterone receptors, attained menopause as defined by the World Health Organization, and on adjuvant hormonal therapy with an aromatase inhibitor- anastrozole, letrozole, or exemestane. Patients with metastatic disease were excluded.

Arm/Group Title	Estring Group
Arm/Group Description	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.
Measure Participants	14
Median (Full Range) [pg/mL]	3.9

Adverse Events

Time Frame	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed through study completion.
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed through study completion.
Arm/Group Title	Estradiol
Arm/Group Description	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.
All Cause Mortality
	Estradiol
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Estradiol
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Estradiol
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.