Clinical Trials Directory

Trials / Suspended

SuspendedNCT03547089

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

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
W. Grant Stevens, MD · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
DEVICEViveve®A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2

Timeline

Start date
2018-08-01
Primary completion
2020-03-01
Completion
2020-03-01
First posted
2018-06-06
Last updated
2019-03-15

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03547089. Inclusion in this directory is not an endorsement.