Trial Outcomes & Findings for Estradiol Levels in Patients Treated With Estring (NCT NCT01923298)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline, 16 weeks

Results posted on

2022-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Estradiol Levels in Patients Treated With Estring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estradiol n=14 Participants 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.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Estring Group n=14 Participants 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.
Changes in Serum Estradiol	3.9 pg/mL Interval 1.1 to 8.9

Adverse Events

Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pavani Chalasani

The University of Arizona Cancer Center

Phone: 520-626-0191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place