Clinical trial · Interventional
A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes
A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment
NCT03547089CI-TRIAL-00037621BRAVOsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genitourinary System; Disorder, Female | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
| Sexual Problem | — | UNRESOLVED | — |
| Vaginal Abnormality | — | UNRESOLVED | — |
| Vaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Viveve® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Viveve treatment
- description
- Group of women who receive Viveve treatment
- interventionNames
- Device: Viveve®
Primary outcomes (1)
- measure
- Sexual dysfunction
- timeFrame
- Baseline, 1 month, 3 months, 6 months
- description
- Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)
Secondary outcomes (3)
- measure
- Sexual distress
- timeFrame
- Baseline, 1 month, 3 months, 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.