Atrophic VaginitisNCT00984399
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
A study testing Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist in people with Atrophic Vaginitis and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Atrophic Vaginitis, Breast Cancer
- What is being tested?
- Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Sep 2009to 13 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Bilateral salpingo-oophorectomy independent of age
Show all 12Show fewer
- If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
- If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished
- At least 18 years of age
- Able to participate in the informed consent process
- Gynecology examination within six months
- Able to read/speak English
Who cannot join
- Inability to give informed consent
- Vaginal bleeding of unknown etiology within 12 months of study entry
- History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York
About this study
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.
- Conditions
- Atrophic Vaginitis, Breast Cancer
- Being tested
- Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist
- Keywords
- vaginitis, Postmenopausal, 17-β estradiol, 09-110
- Medical subject headings
- Atrophic Vaginitis, Breast Neoplasms, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklistDrug
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
Change in Serum Estradiol Baseline to Week 24
To describe patterns of estradiol over the twenty-four week study period.
Measured: 24 weeks
Change in FSH Levels Baseline to Week 24
To describe patterns of FSH levels over the twenty-four week study period.
Measured: 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
Measured: 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
Measured: 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
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study start22 Sep 2009
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Goldfarb, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984399
- Sponsor's protocol ID
- 09-110
- Status last verified
- May 2024
- First submitted
- 24 Sep 2009
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
- ClinicalTrials.gov ID
- NCT00984399
- Acronym / sponsor ID
- 09-110
- Conditions
- Atrophic Vaginitis, Breast Cancer
- Keywords
- vaginitis, Postmenopausal, 17-β estradiol, 09-110
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Sep 2009 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaginal 17β-estradiol, questionnaire , symptom checklist | Experimental | Drug: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklistThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Vaginal bleeding of unknown etiology within 12 months of study entry
- History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklistAlso: 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 estradiolThe 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. | Drug | vaginal 17β-estradiol, questionnaire , symptom checklist |
Primary outcome
Change in Serum Estradiol From Baseline to Week 12
Time frame: 12 weeks
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.
6 secondary outcomes
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
Time frame: 24 weeks
Change in FSH Levels Baseline to Week 24
Time frame: 24 weeks
To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline
Time frame: Baseline
To Compare the Patient's Female Sexual Function Index (FSFI) Scores and Menopause Quality of Life Questionnaire at Baseline, Week 12
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
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Atrophic Vaginitis
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Active, not recruiting
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms
Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
Postmenopausal Atrophic Vaginitis, Genitourinary Syndrome of Menopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari Goldfarb, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist in people with Atrophic Vaginitis and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Estradiol From Baseline to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.