Back to results

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

Primary Purpose

Vaginal Atrophy, Postmenopausal Symptoms, Breast Cancer Female

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vaginal Dehydroepiandrosterone

Vaginal Polycarbophil Moisturizer

About this trial

This is an interventional supportive care trial for Vaginal Atrophy focused on measuring Postmenopausal, Breast Cancer Survivor, Vaginal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Arkansas for Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vaginal DHEA

Vaginal Polycarbophil Moisturizer

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04493333

First Posted

July 27, 2020

Last Updated

May 11, 2023

Sponsor

University of Arkansas

Collaborators

AMAG Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04493333

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 7, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

Collaborators

AMAG Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Atrophy, Postmenopausal Symptoms, Breast Cancer Female, Long-term Survivors

Keywords

Postmenopausal, Breast Cancer Survivor, Vaginal

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Outcomes Assessor

Masking Description

The cytologist's reading specimens will be blinded.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vaginal DHEA

Arm Type

Experimental

Arm Description

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

Arm Title

Vaginal Polycarbophil Moisturizer

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vaginal Dehydroepiandrosterone

Other Intervention Name(s)

Intrarosa®, Vaginal DHEA, Prasterone

Intervention Description

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.

Intervention Type

Combination Product

Intervention Name(s)

Vaginal Polycarbophil Moisturizer

Other Intervention Name(s)

Replens™

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in vaginal atrophy

Description

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joseph A Holley

Phone

501-686-8274

JAHolley@uams.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gloria Richard-Davis, MD

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Kovak, MS

Phone

501-686-8274

mrkovak@uams.edu

First Name & Middle Initial & Last Name & Degree

Gloria Richard-Davis, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs