Purpose

During menopause, there is a decrease in a hormone estrogen, which leads to aging of the vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the vagina, inflammation and a breakdown of natural barriers that keep the vagina healthy and protected from infections. Some menopausal women develop a condition called vaginal atrophy, which causes vaginal dryness, irritation, pain with sex, and itching. We are testing whether an estradiol tablet placed inside the vagina will lead to fewer changes in the types of bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the vagina healthier for a longer. This is important for women with HIV as they are living longer, healthier, sexually active lives due to successful treatment with antiretrovirals.

Conditions

Eligibility

Eligible Ages
Between 45 Years and 70 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • HIV infection
  • Females aged 45-70
  • Menopause defined by having no menstrual periods for 12 consecutive months, confirmed with serum follicle-stimulating hormone (FSH) level >40 IU/ml and serum estradiol level <20 pg/ml
  • Symptomatic vaginal atrophy defined as reporting at least once per week in the past 30 days, 1 or more of the following symptoms of moderate or severe intensity: Dryness, Itching, Irritation, Soreness or pain OR Pain associated with sexual activity at least once
  • Evidence of atrophy on exam, including thin, pale and dry vaginal and vulvar surfaces
  • Agrees not to use vaginal products other than vaginal estradiol tablet during the clinical trial

Exclusion Criteria

  • Current or previous history of breast cancer or estrogen dependent neoplasia
  • Endometrial hyperplasia or polyps
  • Current unexplained abnormal genital bleeding
  • Current or suspected pregnancy
  • Known current or past thromboembolic disease (deep vein thrombosis or pulmonary embolism, not including thrombophlebitis), myocardial infarction or stroke
  • Known blood clotting disorders including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
  • Hysterectomy
  • Known severe liver disease
  • Use of hormones in the 3 months prior to study enrollment
  • Use of any vaginal or vulvar preparations 1 month prior to enrollment
  • Antibiotic use in the past 30 days
  • Abnormal Pap test in the past year
  • Current acute vaginal infection (diagnosed by wet mount at Visit 1 or 2)
  • History of adverse reaction to vaginal estradiol
  • Any serious disease or chronic condition that might interfere with study compliance
  • Unwilling to agree to the provisions of the protocol

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomly assigned to receive treatment with estradiol vaginal tablets or no treatment.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Estradiol Vaginal Insert
Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks.
  • Drug: Estradiol Vaginal Insert
    Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks.
    Other names:
    • VagifemĀ®
    • Vagifem (estradiol vaginal tablet)
No Intervention
No treatment
No intervention

Recruiting Locations

Albert Einstein College of Medicine
Bronx, New York 10461
Contact:
Kerry J Murphy, MD
718-839-7885
kerry.murphy@einsteinmed.org

More Details

Status
Recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

Kerry J Murphy, MD
718-839-7885
kerry.murphy@einsteinmed.org

Detailed Description

HIV may be associated with premature aging in the female genital tract including alterations in the vaginal microbiome and mucosal inflammation, which may increase risk for vaginal atrophy, urinary tract infections (UTI) and other genital tract infections. This study will determine whether use of vaginal estradiol for 12 weeks in menopausal women living with HIV with symptomatic vaginal atrophy will improve atrophy symptoms and the vaginal microbiome and reduce mucosal inflammation thereby improving vaginal health. This study will include 50 participants randomized to treatment with a vaginal estradiol insert or no therapy for 12 weeks and will have 4 study visits.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.