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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493333
• Other study ID #: 239531
• Status: Recruiting
• Phase: Phase 2
• Start date: June 7, 2021
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Arkansas
• Contact: Joseph A Holley
• Phone: 501-686-8274
• Email: JAHolley[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Postmenopausal patients with a history of breast cancer who have completed primary treatment with curative intent, who have been on an aromatase inhibitors (AI) for at least 6 months
• Stage I-III, hormone receptor positive breast cancer regardless of human epidermal growth factor receptor 2 (HER2) status
• Postmenopause defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL (milli-international units per milliliter), or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. FSH level will be documented on all subjects.
• Patients reporting any symptoms of vaginal dryness or dyspareunia as assessed by the Brief Sexual Symptom Checklist for Women (BSSC-W) or the Female Sexual Function Index (FSFI)
• No evidence of active malignant breast or gynecologic disease
• Absence of undiagnosed, persistent or recurring genital bleeding that has not been evaluated to determine the cause [6]
• No planned changes in AI during the study period
• Mammogram (if appropriate, as determined by the treating physician and will be documented) within 12 months of study entry
• Patients with documented normal Pap within 12 months of study entry

Exclusion Criteria:

• Use of any estrogen or progesterone depot-preparation drug or progestin implant in the last 6 months before study entry
• Use of any androgen or anabolic steroids in the last 6 months before study entry
• Use of any oral or transdermal hormonal products (estrogen, progestin, or DHEA) within the last 8 weeks prior to study entry; however, a subject can elect to wait for an 8-week washout period before study entry.
• Use of any vaginal or intrauterine hormonal products in the last 8 weeks; however, a subject can elect to wait for an 8-week washout before study entry.
• Use of any natural over the counter estrogenic products in the last 6 months; however, a subject can elect to wait for a 6-month washout before study entry.
• Concomitant vulvar and vaginal surgical or laser treatments
• Vaginal infection or confounding vulvar or active vaginal disease process
• Prior radiation to the pelvis or history of gynecologic cancer
• Inability to tolerate a vaginal/speculum exam
• Undiagnosed, persistent or recurring genital bleeding or other indication of active pelvic disease process that has not been evaluated [6]
• Clinically significant uncontrolled depression or severe psychiatric symptoms
• If subject has an established routine of inert vaginal lubricant use for routine or occasional relief of vulvar or vaginal symptoms prior to the study period, it may be continued during the study period along with the study drug.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Long-term Survivors
• Postmenopausal Symptoms
• Vaginal Atrophy

Intervention

Drug:
• Vaginal Dehydroepiandrosterone
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.

Combination Product:
• Vaginal Polycarbophil Moisturizer
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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vaginal atrophy	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	12 weeks