Vaginal AtrophyBRAVONCT03547089
A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes
A study testing Viveve® in people with Vaginal Atrophy and Genitourinary System; Disorder, Female, run by W. Grant Stevens, MD at 1 site in United States.
Trial summary
The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy, Genitourinary System; Disorder, Female, Vaginal Abnormality
- What is being tested?
- Viveve®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen
- Self-reported vaginal laxity
- Meet diagnosis of sexual dysfunction
- Patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points
Who cannot join
- Cognitive impairment
- Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
- Women with active breast cancer disease
- Women currently on hormone therapy or who are pregnant
- Women who have had vaginal or pelvic surgery involving the genitalia
Trial locations and contacts
1 site in 1 country.
United States1 site
Marina Plastic Surgery Associates
Marina del Rey, California, 90292
About this study
Official title: A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment
The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.
Read the detailed description
Breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. This therapy typically is administered for five years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. This study will evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast cancer patients.
- Conditions
- Vaginal Atrophy, Genitourinary System; Disorder, Female, Vaginal Abnormality, Sexual Dysfunction, Sexual Problem
- Being tested
- Viveve®
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viveve®Device
A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2
| Study group | Role | What they receive |
|---|---|---|
| Viveve treatment | Experimental | Group of women who receive Viveve treatment Receives: Device: Viveve® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual dysfunction
Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)
Measured: Baseline, 1 month, 3 months, 6 months
Secondary outcomes (3)
Sexual distress
Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)
Measured: Baseline, 1 month, 3 months, 6 months
Vaginal symptoms
Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire
Measured: Baseline, 1 month, 3 months, 6 months
Vaginal laxity
Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)
Measured: Baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Aug 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W. Grant Stevens, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, W. Grant Stevens, MD, Marina Plastic Surgery
- Investigators
- W G Stevens, MD, Principal investigator, Marina Plastic SurgeryAli A Qureshi, MD, Study director, Marina Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547089
- Sponsor's protocol ID
- VI-ISRP-026
- Acronym
- BRAVO
- Status last verified
- Mar 2019
- First submitted
- 24 May 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment
- ClinicalTrials.gov ID
- NCT03547089
- Acronym / sponsor ID
- BRAVO / VI-ISRP-026
- Conditions
- Vaginal Atrophy, Genitourinary System; Disorder, Female, Vaginal Abnormality, Sexual Dysfunction, Sexual Problem
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment issues
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- W. Grant Stevens, MDUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 6 Jun 2018 (actual)
- 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.
The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.
Detailed description
Breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. This therapy typically is administered for five years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. This study will evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viveve treatment | Experimental | Device: Viveve®Group of women who receive Viveve treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen
- Self-reported vaginal laxity
- Meet diagnosis of sexual dysfunction
- Patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points
Key exclusion criteria (5 listed)
- Cognitive impairment
- Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
- Women with active breast cancer disease
- Women currently on hormone therapy or who are pregnant
- Women who have had vaginal or pelvic surgery involving the genitalia
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 |
|---|---|---|
| Viveve®A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2 | Device | Viveve treatment |
Primary outcome
Sexual dysfunction
Time frame: Baseline, 1 month, 3 months, 6 months
Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)
3 secondary outcomes
Sexual distress
Time frame: Baseline, 1 month, 3 months, 6 months
Vaginal symptoms
Time frame: Baseline, 1 month, 3 months, 6 months
Vaginal laxity
Time frame: Baseline, 1 month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Vaginal Atrophy
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Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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.
W G Stevens, MD principal investigator
Marina Plastic Surgery
Ali A Qureshi, MD study director
Marina Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viveve® in people with Vaginal Atrophy and Genitourinary System; Disorder, Female, run by W. Grant Stevens, MD 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 5 inclusion and 5 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: paused, as of the sponsor's last update on 15 Mar 2019. 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?
Results are not available in the source record.
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?
Sexual dysfunction (time frame: Baseline, 1 month, 3 months, 6 months). 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 15 Mar 2019.