Alyssa Dweck MS MD FACOG 1,2,3,4

1.CareMount Medical Group, Mount Kisco,NY

2.Northern Westchester Hospital, Mount Kisco,NY

3.Massachusetts General Hospital Consultant (Vincent’s Memorial Ob/Gyn Service)

4.New York Medical College Adjunct Assistant Professor of Obstetrics & Gynecology

NAMS Poster 2020.

OBJECTIVE:

A user experience trial was conducted from a single site office based gynecology practice to assess a novel and newly patented (US 2016/0193075, EP 1574931.7), over the counter (OTC) and direct to consumer (DTC) genital device to manage troublesome vasomotor symptoms (VMS) during the perimenopausal and menopausal periods. Professionally manufactured (in USA) prototypes were used to assess effectiveness, comfort, ease of use, and general user experience. The purpose of this trial was to provide feedback to modify and implement any improvements for the prototype prior to commercialization.

DESIGN:

Ten female volunteers were invited and participated. Participants consisted of all comers with self-reported moderate to severe VMS. Each was provided with identical written/pictorial product usage instructions. After multiple uses, participants were asked to complete a post-use questionnaire. The patented device is an inverted heart shaped vulvar pad measuring approximately 2.25" in longest dimension. It is composed of a water based polymer in clear gel sandwiched/encased in micro porous polyethylene. The pad is placed in the user's undergarment /panty with a thin adhesive strip (similar to a pantiliner) to abut the clitoris and labia while specifically avoiding the urethra. The well-established mechanism of action involves evaporation of water from the gel polymer upon touching the warm vulva, creating an overwhelming sensation of cool for the wearer. The user's body/skin temperature is not affected. Users were instructed to use the device as often as they needed, day and/or night. Multiple devices were provided to each participant. Each device was packaged in a foil pouch, disposable and required no refrigeration or special preparation. Users were compensated for participation but were unaware of compensation offering until after participation. All data was HIPPA compliant.

RESULTS:

Female participants ranged in age from 43-57. 100% of users found the device easy to use, comfortable and/or unnoticeable in the

panty, and cool immediately on contact. The sensation of cooling was noted immediately on contact by 10/10 users. The 10th user claimed no cooling on sensation but noted that in retrospect, she had a systemic fever unrelated to VMS.

The duration of cooling lasted up to 5-6 hours per pad. 80% (8/10) users claimed VMS improved notably during sleep when the device was

placed prior to bed. 2/10 users claimed VMS improved notably during the day. All users were willing to retry the product in the future and all noted the concept and design of the device was acceptable. 100% of participants were satisfied with their product experience. There were no adverse experience reports as a result of device use. No participants had a negative criticism of the prototype on exit interview and discussion.

CONCLUSION:

This OTC and DTC product offers a novel, safe, easy to use, disposable and discreet option for women to manage VMS. This device satisfies an unmet need for women to address VMS and provides both consumers and health care professionals a novel non-systemic, non-hormonal offering for symptom management. It is appropriate for use in women with breast and other hormone sensitive cancers and is safe to use in conjunction with medication, hormones, herbal products and lifestyle modification.

 This trial provided the necessary information for the inventors to modify and perfect this working prototype with the manufacturer, confirm the novelty and positive consumer acceptance of such a device, market DTC appropriately and to launch expeditiously and

in a streamline fashion.

FUNDING:

This project is not supported by the pharmaceutical or device industry.

Inventors:

Dr Miriam Baker MPH PhD

Dr Alyssa Dweck MS MD FACOG

Dr Nyiri Grigorian LCSW PhD