# Developing a novel, non-hormonal treatment paradigm for vaginal dryness in breast cancer survivors

> **NIH NIH R44** · MADORRA, INC. · 2021 · $848,452

## Abstract

Abstract
The goal of this Fast-Track SBIR is to demonstrate the safety and efficacy of a therapeutic-ultrasound-based
medical device to treat the symptoms of vaginal dryness for breast cancer survivors and postmenopausal
women. Today's best treatments for vaginal dryness all involve the use of hormones; yet, hormonal treatments
are contraindicated for the 1.4 million breast cancer survivors suffering from vaginal dryness (due to the risk of
cancer recurrence). Further, millions of postmenopausal women avoid hormone use because of the long-term
risks and unpleasant side effects. Madorra has developed a medical device that uses therapeutic ultrasound to
revitalize vaginal lubrication, abating symptoms of vaginal dryness completely without the need for hormone
therapy. Preliminary research conducted by the Madorra team has indicated the promise of vaginally applied
therapeutic ultrasound to treat vaginal dryness when used daily in the home by women suffering from vaginal
dryness. However, the modified off-the-shelf ultrasound devices used in those studies were cumbersome and
posed significant usability challenges for the study participants. Women in the study complained about the user
interface, challenges in programming the correct ultrasound dose, difficulty positioning and holding the device
during therapy, and the burdens of cleaning the device after each use. Accordingly, an ultrasound device that
can effectively deliver desired ultrasound directly to vaginal tissue while being easily used (and hence readily
adopted by end users) is required. Madorra has developed such a device based on this user feedback, but it
has not yet been tested clinically. This Fast-Track SBIR proposal would support the first clinical use of the
Madorra device. Phase I encompasses a small, single-arm, Pilot Study of the Madorra device, and Phase II
comprises a larger randomized, sham-controlled Pivotal Study. The Pilot Study (Specific Aims 1-3) will be used
to gather initial clinical use experience data on the Madorra device, including: safety, proof of physiologic
response, validation for ease of use, and preliminary efficacy. The Pivotal Study (Specific Aims 4-6) will collect
statistically significant safety and efficacy data demonstrating the Madorra device's ability to treat vaginal
dryness in comparison to a sham device. These data will be submitted to the FDA in support of device
approval and will serve to irrevocably establish the clinical efficacy of the Madorra device. Once FDA
approved, the Madorra device will be commercialized and will allow millions of breast cancer survivors and
postmenopausal women to regain their sexual wellness and improve their quality of life.
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## Key facts

- **NIH application ID:** 10247092
- **Project number:** 5R44CA225434-03
- **Recipient organization:** MADORRA, INC.
- **Principal Investigator:** Holly Rockweiler
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $848,452
- **Award type:** 5
- **Project period:** 2018-08-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247092

## Citation

> US National Institutes of Health, RePORTER application 10247092, Developing a novel, non-hormonal treatment paradigm for vaginal dryness in breast cancer survivors (5R44CA225434-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247092. Licensed CC0.

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