An interventional study of Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist in Atrophic Vaginitis and Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
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.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 31 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Menopausal at study entry defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
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.
Also known as: The bloodwork will take less than one hour to perform and will be drawn +/- 72hrs from the date the, patient is due for bloodwork.Baseline bloodwork will be drawn within 14 days of study enrollment prior to the initiation of vaginal 25μg 17- β estradiol., Patients will be encouraged to come for their research bloodwork 12-24 hours after the insertion of the vaginal 25μg 17- β estradiol tablets., Patients will record in their diary the time of their last vaginal 10μg 17- β estradiol, tablet insertion. Since we do not know the clinical significance of transient, estradiol elevation in these patients, both the patients and the investigators, will be blinded to the results of these assays for the 24 weeks of study, therapy. We will administer the FSFI survey questionnaire and menopause symptom, checklist at baseline, week 12 and week 24.
This study also gives Anastrozole. No intervention listed here names it: that was found by reading the record.
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Change in Serum Estradiol Baseline to Week 24
To describe patterns of estradiol over the twenty-four week study period.
Time frame: 24 weeks
Change in FSH Levels Baseline to Week 24
To describe patterns of FSH levels over the twenty-four week study period.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 24
| Milestone | Letrozole | Anastrozole |
|---|---|---|
| Started | 12 | 19 |
| Completed | 8 | 14 |
| Not completed | 4 | 5 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Pts did not start treatment | 2 | 2 |
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.
| pg/ml | Letrozole | Anastrozole |
|---|---|---|
| Baseline estradiol | 5.21 (0.6 to 9.8) | 4.46 (1.3 to 8.8) |
| Week 12 estradiol | 5.23 (1 to 8.7) | 6.72 (1.9 to 18) |
| Baseline follicle stimulating hormone (FSH) | 70.92 (36.4 to 121.2) | 68.29 (19.9 to 114.5) |
| Week 12 follicle stimulating hormone (FSH) | 71.67 (33.6 to 115.9) | 63.28 (23.4 to 90.5) |
| pg/ml | Letrozole | Anastrozole |
|---|---|---|
| Baseline Estradiol | 5.21 (0.6 to 9.8) | 4.46 (1.3 to 8.8) |
| Week 12 Estradiol | 5.23 (1 to 8.7) | 6.72 (1.9 to 18) |
To describe patterns of estradiol over the twenty-four week study period.
| pg/ mL | Letrozole | Anastrozole |
|---|---|---|
| Baseline Estradiol | 5.21 (0.6 to 9.8) | 4.46 (1.3 to 8.8) |
| Week 24 Estradiol | 7.55 (3.5 to 21.6) | 9.26 (3.3 to 23.7) |
To describe patterns of FSH levels over the twenty-four week study period.
| mIU/ml | Letrozole | Anastrozole |
|---|---|---|
| Baseline FSH | 70.93 (36.4 to 121.2) | 9.26 (3.3 to 23.7) |
| Week 24 FSH | 74.07 (35.3 to 105.3) | 70.51 (27.9 to 114.9) |
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
| units on a scale | Letrozole | Anastrozole |
|---|---|---|
| To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline | 14.61 (2.7 to 26.2) | 16.01 (5.2 to 25.9) |
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
| units on a scale | Letrozole | Anastrozole |
|---|---|---|
| To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 12 | 17.75 (3 to 29.6) | 18.87 (3 to 29.6) |
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
| units on a scale | Letrozole | Anastrozole |
|---|---|---|
| To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 24 | 18.32 (2 to 30.8) | 21.09 (5.3 to 30.8) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Letrozole | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Anastrozole | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Letrozole | Anastrozole | Total |
|---|---|---|---|
| Median | 55 (47 to 70) | 56 (46 to 73) | 55 (46 to 73) |
| Sex: Female, Male(Participants) | Letrozole | Anastrozole | Total |
|---|---|---|---|
| Female | 12 | 19 | 31 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Letrozole | Anastrozole | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 8 | 18 | 26 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Letrozole | Anastrozole | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 12 | 18 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Letrozole | Anastrozole | Total |
|---|---|---|---|
| United States | 12 | 19 | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2009 to primary completion in May 2024, 175 months.
Results were first posted in Dec 2025, 1 year 6 months after primary completion.
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