Ensayos clínicos

Inclusion Criteria:

- Ability to provide written informed consent or have an appropriate representative
available to do so

- Ability to complete questionnaires by themselves or with assistance

- Ability to comply with treatment plan and follow-up visits

- Female patients >= 18 years

- Histological confirmation of adenocarcinoma of the breast stage 0 - III. Patients with
stage III require three or more years from initial diagnosis with no evidence of
recurrence

- Natural, surgical, or medically induced menopause

- Self-report of vaginal itching, irritation, burning, dryness, or dyspareunia

- Triple negative or HER2 positive breast cancer =< 3 years from initial diagnosis

Exclusion Criteria:

- Receiving any form of hormone replacement therapy, including topical estrogens,
testosterone, and dehydroepiandrosterone (DHEA) or selective estrogen receptor
modulator (SERM), including tamoxifen and ospemifene in the previous 3 months prior to
enrollment

- Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus,
vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history
of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent
urinary tract infection, genital infection, history of vaginal or pelvic radiation

- Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity

- Pelvic organ prolapse greater than stage II

- Pelvic surgery within 6 months

- Known allergy to lidocaine or prilocaine

- Known allergy to silicone

- Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of
therapy

- Hemoglobin < 11.6 g/dL or > 15.5 g/dL. If the laboratory reports a single,
non-clinically significant result for any of these studies and is the only excluding
factor it may be repeated 1 week later if the patient wishes. Normalization of that
laboratory study will then be considered non-exclusionary

- Hematocrit < 34.9% or > 44.9%. If the laboratory reports a single, non-clinically
significant result for any of these studies and is the only excluding factor it may be
repeated 1 week later if the patient wishes. Normalization of that laboratory study
will then be considered non-exclusionary

- White blood cell count < 3.4 X 10^9/L or > 10.5 X 10^9/L. If the laboratory reports a
single, non-clinically significant result for any of these studies and is the only
excluding factor it may be repeated 1 week later if the patient wishes. Normalization
of that laboratory study will then be considered non-exclusionary

- Platelet count < 150 X 10^ 9/L or > 450 X 10^9/L. If the laboratory reports a single,
non-clinically significant result for any of these studies and is the only excluding
factor it may be repeated 1 week later if the patient wishes. Normalization of that
laboratory study will then be considered non-exclusionary

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of the treatment

- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy. NOTE: Patients known to be
HIV positive, but without clinical evidence of an immunocompromised state, are
eligible for this trial

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.