Breast CancerNCT02528383
Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors
A study testing Vagifem in people with Breast Cancer, run by Susan Tannenbaum at 1 site in United States.
Trial summary
Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as vaginal dryness and urinary discomfort. The purpose of this research study is to see the benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal symptoms and health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vagifem
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Treatment of Urogenital symptoms with Vagifem, as deemed appropriate by the treating physician
- History of breast cancer stages 0-III
- Currently being treated with Aromatase Inhibitors (brand not restrictive) for 3 months or longer
- Postmenopausal women including those with medically induced menopause
- Urogenital symptoms consistent with vaginal atrophy.
- Age 18 years or greater
Show all 9Show fewer
- Able to participate in informed consent process
- Able to read/speak English
- Able to take daily doses of Vitamin D and Calcium
Who cannot join
- Abnormal or unexplained uterine bleeding
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors: Systemic Impact Versus Local Objective Benefits and Quality of Life
Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as vaginal dryness and urinary discomfort. The purpose of this research study is to see the benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal symptoms and health. The investigators also want to monitor whether the bones might be impacted by estrogen or its absence. If there is an effect on bones, it means that some estrogen may be absorbed from the tablet to affect other places in the body. The investigators are hoping to prove this is not the case. The investigators will also be measuring the quality of life of women participating in the study.
Read the detailed description
Breast cancers are made of different subtypes but by far the most common characteristic is their estrogen receptor positivity. Seventy percent of breast cancers are estrogen receptor positive and therefore responsive to the hormone estrogen, which acts as a stimulus for growth and survival of the cancer. Studies have repeatedly shown that estrogen deprivation results in prevention of breast cancer in high-risk women, and reduced recurrence of the cancer both locally and systemically as well as overall survival improvement in those women. The majority of women with estrogen sensitive breast cancer are placed on anti-estrogen therapy to prevent the cancer from returning. Even in menopause, women have estrogen produced in their bodies. Many parts of a woman's body require estrogen for normal functioning and reducing the amount of estrogen can affect women significantly in different ways. Some women have significant symptoms like vaginal dryness, which may result in painful sexual relations, discomfort, and frequent urinary tract (bladder) infections. Although the investigators goal is to reduce estrogen to prevent breast cancer from returning, quality of life (how women feel) matters during treatment which can last 5-10 years. A major question is: how medications such as Vagifem that are used to treat vaginal symptoms affect the rest of the body?
This question has not been fully answered and is the reason this study is being done. The safest topical estrogen, Vagifem, is a commercially available tablet which is placed in the vagina. Vagifem works well in many women and is considered to be safe. It is used by gynecologists and cancer doctors in this setting all the time. It is not a new product and has been on the market for many years. Its effects on other parts of the body have not been tested. The investigators are poised to help answer this question by hypothesizing the following:
- It is impossible to know what impact a given estrogen level has in distant sites, the investigators will however measure these to see if estrogen levels rise in the blood when women are treated with vaginal estrogen tablets that are commercially available. The investigators hypothesize that there will not be any elevation in measurable estrogen levels using very sensitive assays.
- The investigators also propose using a topical vaginal estrogen application (one that is commercially available) while carefully monitoring its' effects locally in the vagina and its possible impact on bone health. The investigators expect women to have improved vaginal exams as well as improvement in overall quality of life with this treatment. It is also expected that there will be no impact on bone turnover by this topical estrogen replacement.
Postmenopausal women on aromatase inhibitors interested in study participation will be asked to participate for a three month period.
- Conditions
- Breast Cancer
- Being tested
- Vagifem
- Keywords
- Postmenopausal Women on Aromatase Inhibitors, Vagifem
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VagifemBehavioural
Women participating in the study will undergo clinical assessments, blood work and complete the quality of life questionnaire at baseline, 6 weeks and 12 weeks study time points. The following will be assessed:
- Effect of low dose Vagifem, 10ug tablet on vaginal atrophy.
- Effect of low dose Vagifem, 10ug tablet on sex hormones and bone health biomarkers.
- Impact of treatment on quality of life
| Study group | Role | What they receive |
|---|---|---|
| Vagifem | Experimental | Postmenopausal women diagnosed with breast cancer, are currently on an anti-estrogen called an aromatase inhibitor and you have agreed to undergo treatment with Vagifem based on your physician's recommendation. Receives: Behavioral: Vagifem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum estrogen levels
Changes in serum estrogen levels will be measured up to 12 weeks in post-menopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal estradiol 10 ug tablet, Vagifem.
Measured: 12 Weeks
Secondary outcomes (1)
Quality of Life
Measure changes in bone health biomarkers up to 12 weeks in post-menopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal estradiol 10 ug tablet, Vagifem to evaluate wellness of quality of life.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Tannenbaum
- Sponsor type
- University, hospital or other
- Collaborators
- Connecticut Breast Health Initiative
- Responsible party
- Sponsor-investigator, Susan Tannenbaum, UConn Health
- Investigators
- Susan Tannenbaum, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528383
- Sponsor's protocol ID
- 15-143-3
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2015
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors: Systemic Impact Versus Local Objective Benefits and Quality of Life
- ClinicalTrials.gov ID
- NCT02528383
- Acronym / sponsor ID
- 15-143-3
- Conditions
- Breast Cancer
- Keywords
- Postmenopausal Women on Aromatase Inhibitors, Vagifem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Susan TannenbaumUniversity, hospital or other
- Collaborators
- Connecticut Breast Health Initiative
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as vaginal dryness and urinary discomfort. The purpose of this research study is to see the benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal symptoms and health. The investigators also want to monitor whether the bones might be impacted by estrogen or its absence. If there is an effect on bones, it means that some estrogen may be absorbed from the tablet to affect other places in the body. The investigators are hoping to prove this is not the case. The investigators will also be measuring the quality of life of women participating in the study.
Detailed description
Breast cancers are made of different subtypes but by far the most common characteristic is their estrogen receptor positivity. Seventy percent of breast cancers are estrogen receptor positive and therefore responsive to the hormone estrogen, which acts as a stimulus for growth and survival of the cancer. Studies have repeatedly shown that estrogen deprivation results in prevention of breast cancer in high-risk women, and reduced recurrence of the cancer both locally and systemically as well as overall survival improvement in those women. The majority of women with estrogen sensitive breast cancer are placed on anti-estrogen therapy to prevent the cancer from returning. Even in menopause, women have estrogen produced in their bodies. Many parts of a woman's body require estrogen for normal functioning and reducing the amount of estrogen can affect women significantly in different ways. Some women have significant symptoms like vaginal dryness, which may result in painful sexual relations, discomfort, and frequent urinary tract (bladder) infections. Although the investigators goal is to reduce estrogen to prevent breast cancer from returning, quality of life (how women feel) matters during treatment which can last 5-10 years. A major question is: how medications such as Vagifem that are used to treat vaginal symptoms affect the rest of the body?
This question has not been fully answered and is the reason this study is being done. The safest topical estrogen, Vagifem, is a commercially available tablet which is placed in the vagina. Vagifem works well in many women and is considered to be safe. It is used by gynecologists and cancer doctors in this setting all the time. It is not a new product and has been on the market for many years. Its effects on other parts of the body have not been tested. The investigators are poised to help answer this question by hypothesizing the following:
- It is impossible to know what impact a given estrogen level has in distant sites, the investigators will however measure these to see if estrogen levels rise in the blood when women are treated with vaginal estrogen tablets that are commercially available. The investigators hypothesize that there will not be any elevation in measurable estrogen levels using very sensitive assays.
- The investigators also propose using a topical vaginal estrogen application (one that is commercially available) while carefully monitoring its' effects locally in the vagina and its possible impact on bone health. The investigators expect women to have improved vaginal exams as well as improvement in overall quality of life with this treatment. It is also expected that there will be no impact on bone turnover by this topical estrogen replacement.
Postmenopausal women on aromatase inhibitors interested in study participation will be asked to participate for a three month period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagifem | Experimental | Behavioral: VagifemPostmenopausal women diagnosed with breast cancer, are currently on an anti-estrogen called an aromatase inhibitor and you have agreed to undergo treatment with Vagifem based on your physician's recommendation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Treatment of Urogenital symptoms with Vagifem, as deemed appropriate by the treating physician
- History of breast cancer stages 0-III
- Currently being treated with Aromatase Inhibitors (brand not restrictive) for 3 months or longer
- Postmenopausal women including those with medically induced menopause
- Urogenital symptoms consistent with vaginal atrophy.
Key exclusion criteria (2 listed)
- Abnormal or unexplained uterine bleeding
- Unable to give informed consent
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 |
|---|---|---|
| VagifemWomen participating in the study will undergo clinical assessments, blood work and complete the quality of life questionnaire at baseline, 6 weeks and 12 weeks study time points. The following will be assessed: 1. Effect of low dose Vagifem, 10ug tablet on vaginal atrophy. 2. Effect of low dose Vagifem, 10ug tablet on sex hormones and bone health biomarkers. 3. Impact of treatment on quality of life | Behavioural | Vagifem |
Primary outcome
Changes in serum estrogen levels
Time frame: 12 Weeks
Changes in serum estrogen levels will be measured up to 12 weeks in post-menopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal estradiol 10 ug tablet, Vagifem.
1 secondary outcome
Quality of Life
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
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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.
Susan Tannenbaum, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagifem in people with Breast Cancer, run by Susan Tannenbaum at 1 site 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 9 inclusion and 2 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in serum estrogen levels (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 18 Sep 2017.