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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493333
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : June 9, 2022
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Postmenopausal Symptoms Breast Cancer Female Long-term Survivors Drug: Vaginal Dehydroepiandrosterone Combination Product: Vaginal Polycarbophil Moisturizer Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: The cytologist's reading specimens will be blinded.
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Vaginal DHEA
Vaginal insert with 6.5 mg vaginal DHEA self-administered once daily at bedtime for 12 weeks
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.
Other Names:
  • Intrarosa®
  • Vaginal DHEA
  • Prasterone

Active Comparator: Vaginal Polycarbophil Moisturizer
Prefilled vaginal applicator with 2.5 g of polycarbophil vaginal moisturizing gel, self-administered two times per week at night for 12 weeks
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.
Other Name: Replens™




Primary Outcome Measures :
  1. Change in vaginal atrophy [ Time Frame: 12 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493333


Contacts
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Contact: Joseph A Holley 501-686-8274 JAHolley@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Matthew Kovak, MS    501-686-8274    mrkovak@uams.edu   
Principal Investigator: Gloria Richard-Davis, MD         
Sponsors and Collaborators
University of Arkansas
AMAG Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Gloria Richard-Davis, MD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04493333    
Other Study ID Numbers: 239531
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arkansas:
Postmenopausal
Breast Cancer Survivor
Vaginal
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Calcium polycarbophil
Psyllium
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antidiarrheals
Gastrointestinal Agents
Cathartics