Neoplasms

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Atrophy

Breast Diseases

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Aromatase Inhibitors

Psyllium

Calcium polycarbophil

Dehydroepiandrosterone

Calcium

Calcium, Dietary

Adjuvants, Immunologic

Immunologic Factors

Loperamide

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DHEA (Dehydroepiandrosterone)

Vaginal insert with 6.5 mg vaginal DHEA self-administered once daily at bedtime for 12 weeks

Prefilled vaginal applicator with 2.5 g of polycarbophil vaginal moisturizing gel, self-administered two times per week at night for 12 weeks

This is a vaginally administered suppository steroid indicated for the treatment of moderate to severe dyspareunia, a frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause.

Vaginal Dehydroepiandrosterone

This is an FDA cleared, over-the-counter personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is non-sterile, water-based, non-irritating, non-greasy, non-staining vaginal gel delivered as a long-lasting moisturizer for vaginal dryness.

Vaginal Polycarbophil Moisturizer

Gloria Richard-Davis, MD

The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone. By doing this study, the investigators hope to learn if Intrarosa® can improve vaginal discomfort. Participants will be assigned to one of two groups. One group will use Intrarosa® once a day. The other group will use Replens™ two times a week.

This will be a two-armed, randomized Phase II trial. All study subjects will be asked to fill out a simple 5-question sexual functioning survey. If any concern about sexual functioning is noted, the subject will also be asked to fill out a more extensive Sexual functioning tool, to help determine which domain of sexual functioning is the most bothersome.

Subjects who complete the initial screening will be randomly assigned to the Intrarosa® or Replens™ arm by a 1:1 ratio. Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks.

At baseline and at 12 weeks, subjects will undergo a physical exam including clinical breast and gynecological exam. During gynecologic exams, the vaginal Potential of Hydrogen (pH) will be determined and a swab of vaginal epithelium sent for determination of the Vaginal Maturation Index (VMI) and Maturation Value (MV). These will be used as objective physiologic markers to determine the improvement in vaginal atrophy. The cytologist's reading specimens will be blinded.

Additionally, all study subjects will be asked to fill out questionnaires at baseline and again in 12 weeks.

Subjects are randomly assigned to the Intrarosa® or Replens™ arm by a 1:1 ratio. Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week). Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks.

The cytologist's reading specimens will be blinded.

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors

Comparison of Vaginal Dehydroepiandrosterone (DHEA) to Control for Treatment of Vaginal Symptoms in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors: A Phase II Randomized Trial

Improvement of the vaginal maturation index (VMI) calculated based on the decrease of the percentage of the parabasal cells and the increase of the sum of the percentages of the intermediate and superficial cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors	NCT04493333	Vaginal Atrophy Postmenopausal ... Breast Cancer F... Long-term Survi...	Vaginal Dehydro... Vaginal Polycar...	18 Years - 70 Years	University of Arkansas
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors	NCT04493333	Vaginal Atrophy Postmenopausal ... Breast Cancer F... Long-term Survi...	Vaginal Dehydro... Vaginal Polycar...	18 Years - 70 Years	University of Arkansas

Spots Global Cancer Trial Database for vaginal polycarbophil moisturizer