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Trial record 2 of 2124 for:    ESTRADIOL

Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

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: NCT04079218
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Novo Nordisk A/S
Information provided by (Responsible Party):
Kerry Murphy, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE September 3, 2019
First Posted Date  ICMJE September 6, 2019
Last Update Posted Date September 6, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Vaginal Atrophy Symptoms [ Time Frame: Between baseline and 6 and 12 weeks ]
    Change in clinical symptoms measured by most bothersome symptom (MBS) of vaginal atrophy after estradiol treatment
  • Vaginal Microbiome [ Time Frame: Between baseline and 6 and 12 weeks ]
    Changes in the vaginal microbiome, specifically the relative abundance of protective lactobacillus species L. crispatus as measured by lllumina sequencing and quantities of protective lactobacilli species (L. crispatus, L. jensenii and L. gasseri) as measured by quantitative PCR (qPCR)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Vaginal Microbiome [ Time Frame: Between baseline and 6 and 12 weeks ]
    Changes in relative abundance and quantities of bacterial vaginosis associated species
  • Vaginal cytokines and chemokines [ Time Frame: Between baseline and 6 and 12 weeks ]
    Changes in concentrations of cytokines and chemokines in cervicovaginal lavage (CVL)
  • Immunoglobulin (Ig)A and IgG coated bacteria [ Time Frame: Baseline and 6 and 12 weeks ]
    Differences in levels of live IgA+IgG+ coated, live IgA+IgG- coated, live IgA-IgG-coated and dead bacteria
  • HIV-1 RNA levels in the genital tract [ Time Frame: Baseline and 6 and 12 weeks ]
    HIV-1 RNA testing from cervicovaginal lavage fluid
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
Official Title  ICMJE The Impact of HIV on Accelerated Aging in the Female Genital Tract: a Pilot Trial of Topical Estradiol to Improve the Vaginal Microbiome and Symptoms of Vaginal Atrophy in Menopausal Women With HIV
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to receive treatment with estradiol vaginal tablets or no treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • Vaginal Atrophy
  • Menopause
  • Menopause Related Conditions
  • Aging
  • Premature Aging
  • Atrophic Vaginitis
  • Dysbiosis
  • Vaginitis
Intervention  ICMJE 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:
  • Vagifem®
  • Vagifem (estradiol vaginal tablet)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Estradiol Vaginal Insert
  • No Intervention: No treatment
    No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kerry J Murphy, MD 718-839-7885 kerry.murphy@einstein.yu.edu
Contact: Marla J Keller, MD 718-430-3240 marla.keller@einstein.yu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04079218
Other Study ID Numbers  ICMJE 2019-10529
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After publication of the main study findings, external investigators may contact the Principal Investigator Dr. Kerry Murphy for de-identified datasets.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Within 12 months after publication
Access Criteria: De-identified electronic datasets of published results will be made available to external investigators in a format in which subsequent statistical analyses can be performed.
Responsible Party Kerry Murphy, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Kerry J Murphy, MD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP