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The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaginal 17β-estradiol, questionnaire , symptom checklist | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist | Drug | The goal is to have 30 patients on letrozole and 30 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 10mcg vaginal 17-β estradiol tablets. Each subject will serve as her own control. We will monitor serum estradiol and follicle stimulating hormone (FSH) levels closely from 0-24 weeks. We will measure serum estradiol and FSH levels at baseline, and subsequently at weeks 2, 7, 12, 18 and 24 after commencing therapy with 10mcg vaginal 17-β estradiol. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Estradiol From Baseline to Week 12 | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks | |
| Change in Serum Estradiol Baseline to Week 24 | To describe patterns of estradiol over the twenty-four week study period. |
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Inclusion Criteria:
History of breast cancer, stages I-III with pathology confirmed at MSKCC
Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease.
Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole
Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence
Menopausal at study entry defined as:
At least 18 years of age
Able to participate in the informed consent process
Gynecology examination within six months
Able to read/speak English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari Goldfarb, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan Kettering Cancer Center @ Suffolk |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Anastrozole |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2018 |
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| 24 weeks |
| Change in FSH Levels Baseline to Week 24 | To describe patterns of FSH levels over the twenty-four week study period. | 24 weeks |
| To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at 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 | Baseline |
| To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 12 | 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 | Week 12 |
| To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, 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 | Week 24 |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital | Sleepy Hollow | New York | United States |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Estradiol From Baseline to Week 12 | 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. | Posted | Mean | Full Range | pg/ml | 12 weeks |
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| Secondary | 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. | Posted | Mean | Full Range | pg/ml | 12 weeks |
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| Secondary | Change in Serum Estradiol Baseline to Week 24 | To describe patterns of estradiol over the twenty-four week study period. | Posted | Mean | Full Range | pg/ mL | 24 weeks |
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| Secondary | Change in FSH Levels Baseline to Week 24 | To describe patterns of FSH levels over the twenty-four week study period. | Posted | Mean | Full Range | mIU/ml | 24 weeks |
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| Secondary | To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at 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 | Posted | Mean | Full Range | units on a scale | Baseline |
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| Secondary | To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 12 | 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 | Posted | Mean | Full Range | units on a scale | Week 12 |
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| Secondary | To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, 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 | Posted | Mean | Full Range | units on a scale | Week 24 |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shari Goldfarb, MD | Memorial Sloan Kettering Cancer Center | 646-888-5080 | goldfars@mskcc.org |
| May 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D001943 | Breast Neoplasms |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Baseline follicle stimulating hormone (FSH) |
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| Week 12 follicle stimulating hormone (FSH) |
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