Trials / Terminated
TerminatedNCT03739983
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention
Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention for Breast Cancer Patients Treated With Aromatase Inhibitors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Breast cancer patients commonly take medications to reduce the risk of recurrence, including aromatase inhibitors (AIs). AIs can cause significant side effects that reduce patient adherence. Early discontinuation of AI therapy results in an increased risk of cancer recurrence and increased risk of breast cancer-related death. Common side effects include vaginal dryness and vulvovaginal atrophy leading to worsening sexual function. To increase AI adherence, the investigators will study a non-pharmaceutical Vaginal Renewal Program (VRP) aimed at stimulating nitric oxide production to consequently increase vaginal lubrication, and improve the symptoms of vulvovaginal atrophy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vaginal Renewal Program | Therapeutic vibrating wand. |
Timeline
- Start date
- 2019-11-19
- Primary completion
- 2020-03-10
- Completion
- 2020-03-10
- First posted
- 2018-11-14
- Last updated
- 2021-10-20
- Results posted
- 2021-09-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03739983. Inclusion in this directory is not an endorsement.