Trial Outcomes & Findings for Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen (NCT NCT00984399)

Last Updated: 2025-12-09

Results Overview

To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Letrozole This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Overall Study STARTED	12	19
Overall Study COMPLETED	8	14
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Letrozole This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Overall Study Adverse Event	0	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	0	1
Overall Study Pts did not start treatment	2	2

Baseline Characteristics

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Total n=31 Participants Total of all reporting groups
Age, Continuous	55 years n=4 Participants	56 years n=50 Participants	55 years n=518 Participants
Sex: Female, Male Female	12 Participants n=4 Participants	19 Participants n=50 Participants	31 Participants n=518 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=4 Participants	0 Participants n=50 Participants	2 Participants n=518 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=4 Participants	18 Participants n=50 Participants	26 Participants n=518 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants	1 Participants n=50 Participants	3 Participants n=518 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	1 Participants n=50 Participants	1 Participants n=518 Participants
Race (NIH/OMB) White	12 Participants n=4 Participants	18 Participants n=50 Participants	30 Participants n=518 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=518 Participants
Region of Enrollment United States	12 Participants n=4 Participants	19 Participants n=50 Participants	31 Participants n=518 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Change in Serum Estradiol From Baseline to Week 12 Baseline estradiol	5.21 pg/ml Interval 0.6 to 9.8	4.46 pg/ml Interval 1.3 to 8.8
Change in Serum Estradiol From Baseline to Week 12 Week 12 estradiol	5.23 pg/ml Interval 1.0 to 8.7	6.72 pg/ml Interval 1.9 to 18.0
Change in Serum Estradiol From Baseline to Week 12 Baseline follicle stimulating hormone (FSH)	70.92 pg/ml Interval 36.4 to 121.2	68.29 pg/ml Interval 19.9 to 114.5
Change in Serum Estradiol From Baseline to Week 12 Week 12 follicle stimulating hormone (FSH)	71.67 pg/ml Interval 33.6 to 115.9	63.28 pg/ml Interval 23.4 to 90.5

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
To Compare the Rise in Estradiol in Women on Letrozole vs. Anastrozole During Treatment With Low Dose Vaginal 10 µg 17- β Estradiol to See if There Are Differences Between Aromatase Inhibitors. Week 12 Estradiol	5.23 pg/ml Interval 1.0 to 8.7	6.72 pg/ml Interval 1.9 to 18.0
To Compare the Rise in Estradiol in Women on Letrozole vs. Anastrozole During Treatment With Low Dose Vaginal 10 µg 17- β Estradiol to See if There Are Differences Between Aromatase Inhibitors. Baseline Estradiol	5.21 pg/ml Interval 0.6 to 9.8	4.46 pg/ml Interval 1.3 to 8.8

SECONDARY outcome

Timeframe: 24 weeks

To describe patterns of estradiol over the twenty-four week study period.

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Change in Serum Estradiol Baseline to Week 24 Baseline Estradiol	5.21 pg/ mL Interval 0.6 to 9.8	4.46 pg/ mL Interval 1.3 to 8.8
Change in Serum Estradiol Baseline to Week 24 Week 24 Estradiol	7.55 pg/ mL Interval 3.5 to 21.6	9.26 pg/ mL Interval 3.3 to 23.7

SECONDARY outcome

Timeframe: 24 weeks

To describe patterns of FSH levels over the twenty-four week study period.

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
Change in FSH Levels Baseline to Week 24 Baseline FSH	70.93 mIU/ml Interval 36.4 to 121.2	9.26 mIU/ml Interval 3.3 to 23.7
Change in FSH Levels Baseline to Week 24 Week 24 FSH	74.07 mIU/ml Interval 35.3 to 105.3	70.51 mIU/ml Interval 27.9 to 114.9

SECONDARY outcome

Timeframe: Baseline

The FSFI measures six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction and pain. An increase in FSFI score means better sexual function. The individual domain scores and full scale score of the FSFI are derived by the computational formula outlined in the table below. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the domain factor (see below). The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Domain Questions Score range Factor Minimum score Maximum score Desire 1, 2 1-5 0.6 1.2 6.0 Arousal 3, 4, 5, 6 0-5 0.3 0 6.0 Lubrication 7, 8, 9, 10 0-5 0.3 0 6.0 Orgasm 11, 12, 13 0-5 0.4 0 6.0 Satisfaction 14, 15, 16 0 (or 1)-5 0.4 0 6.0 Pain 17, 18, 19 0-5 0.4 0 6.0 Full Scale Score Range 2.0 36.0

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline	14.61 units on a scale Interval 2.7 to 26.2	16.01 units on a scale Interval 5.2 to 25.9

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 12	17.75 units on a scale Interval 3.0 to 29.6	18.87 units on a scale Interval 3.0 to 29.6

SECONDARY outcome

Timeframe: Week 24

The FSFI measures six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction and pain. The individual domain scores and full scale score of the FSFI are derived by the computational formula outlined in the table below. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the domain factor (see below). The full scale score is obtained by adding the six domain scores. It should be noted that within the individual domains, a domain score of zero indicates that no sexual activity was reported during the past month. Domain Questions Score range Factor Minimum score Maximum score Desire 1, 2 1-5 0.6 1.2 6.0 Arousal 3, 4, 5, 6 0-5 0.3 0 6.0 Lubrication 7, 8, 9, 10 0-5 0.3 0 6.0 Orgasm 11, 12, 13 0-5 0.4 0 6.0 Satisfaction 14, 15, 16 0 (or 1)-5 0.4 0 6.0 Pain 17, 18, 19 0-5 0.4 0 6.0 Full Scale Score Range 2.0 36.0

Outcome measures

Outcome measures
Measure	Letrozole n=12 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.	Anastrozole n=19 Participants This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 24	18.32 units on a scale Interval 2.0 to 30.8	21.09 units on a scale Interval 5.3 to 30.8

Adverse Events

Letrozole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anastrozole

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. Shari Goldfarb, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-5080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place