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Menopausal Vaginal Microbiome

Sponsor
FemTec Health Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05122065
Collaborator
(none)
432
Enrollment
12.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this study the investigators will analyze the vaginal microbiome of menopausal women in order to shed light on its potential implication on menopausal symptoms and quality of life. Moreover, the investigators will assess the effect of hormone replacement treatment on symptoms and overall quality of life during menopause and whether women under hormone replacement treatment have distinct vaginal microbiome profiles.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    432 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Defining the Vaginal Microbiome and the Vaginal pH of Menopausal Women With and Without Genitourinary Syndrome and With and Without Hormone Replacement Therapy
    Anticipated Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Feb 28, 2022
    Anticipated Study Completion Date :
    Dec 15, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Asymptomatic/non-HRT

    Samples derived from women in menopause who do not self-reportedly experience GSM (Genitourinary Syndrome of Menopause) and who do not take HRT (Hormone Replacement Therapy).
    Asymptomatic/HRT

    Samples derived from women in menopause who do not self-reportedly experience GSM and who take HRT
    GSM/non-HRT

    Samples derived from women in menopause who self-reportedly experience GSM and who do not take HRT
    GSM/HRT

    Samples derived from women in menopause who self-reportedly experience GSM and who take HRT

    Outcome Measures

    Primary Outcome Measures

    1. Vaginal microbiome sample collection [Baseline]

      Identify microbiome-based bacterial signatures to distinguish the different menopausal groups and the CST (Community State Type) group clustering according to the vaginal microbiome of menopausal women.

    Secondary Outcome Measures

    1. Demographic questionnaire [Baseline]

      Data will include ethnic/cultural background, body weight, and height, age, sexual orientation, relationship status, education status/academic background, employment status, current occupation, area of residence, chronic condition(s), number of children, and type of birth given, age of last period, last Pap test and thyroid test, contraception method, use of prescription or non-prescription medications and supplements, smoking and alcohol habits, dietary habits, information source about menopause, attitude towards talking about menopause, self-image and changes on hair/skin/nails, dental health and body weight during menopause, awareness of menopause state, online services/app or products used during menopause, delivery address for testing kits.

    2. Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire [Baseline]

      Participants will answer a questionnaire including four multi-item scales addressing symptoms impact on: 1) activities of daily living, 2) emotional well-being, 3) sexual functioning, and 4) self-concept and body image. The possible score range for all domain scales is 0 to 4, with higher scores denoting greater impact of vaginal symptoms.

    3. Menopause Rating Scale (MRS) questionnaire [Baseline]

      Participants will answer the 11-question questionnaire regarding the presence or absence and intensity of their menopause-related symptoms. The minimum value is zero and the maximum is four with the latter indicating very severe symptoms.

    4. Brief Resilience Scale (BRS) questionnaire [Baseline]

      Participants will answer a 6-question questionnaire concerning their ability to recover from stress. This questionnaire has two types of questions namely, one with positive meaning in which the scoring scale is from 1 (strongly disagree) to 5 (strongly agree) and the second one has negative meaning with the scoring scale ranging from 1 (strongly agree) to 5 (strongly disagree).

    5. Vaginal pH -at home test kit [Baseline]

      Participants will be asked to take a vaginal pH sample in duplicate. Participants will be asked to fill in a form with their vaginal pH test results obtained from the vaginal pH test.

    6. Facial Skin Type Test [Baseline]

      The facial skin type testing kit (USP Solutions, Klagenfurt, Austria) will include two "Skin Oil Tester Sebutapes", a skin test results template, and a product insert with useful information and instructions for the participants.

    7. Body Hydration Test [Baseline]

      Participants will be asked to take the body hydration test once on their hand and once on their leg. The body hydration testing kit (USP Solutions, Klagenfurt, Austria) will include two "Dry Skin Test D-Squames", a skin test results template, and a product insert with useful information and instructions for the participants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Women who are females from birth

    • Women between 40-70 years old

    • Women that are US residents, understand, and speak English

    • Women of all race and ethnicities

    • Women that are postmenopausal (at least 12 consecutive months without a period)

    • Women with a naturally occuring menopause

    • Women willing to abstain from all sexual activity, feminine hygiene products (eg. douches, wipes, washes, sprays, powders, moisturizers/lubricants, deodorant suppositories, tablet suppositories, anti-itch creams, hot tubs) on the vaginal area, and any vaginal suppositories for 48 hours before sampling

    • Women who are healthy (without GSM)

    • Women who have GSM:

    1. with formal diagnosis of GSM, or

    2. who regularly experience a couple of the following symptoms: (i) vaginal dryness, vaginal burning, vaginal discharge & genital itching, vaginal irritation, (ii) light bleeding, discomfort or pain during or after intercourse, decreased lubrication during intercourse, decreased arousal, orgasm, libido, (iii) painful or difficult urination (dysuria), urinary frequency and urgency, recurrent UTIs (Urinary Tract Infections).

    • Women who either take or do not take HRT, including estrogen-only medicines, combination of estrogen/progestin medicines, combination of estrogen/other medicines.
    Exclusion Criteria:

    • Women suffering from gynecological diseases including polycystic ovary syndrome, endometriosis, pelvic inflammatory disease, active HPV (human papillomavirus) or herpes simplex virus in the past few months, BV (Bacterial Vaginosis), yeast infections, or positive for any STD (Sexually Transmitted Disease; genital warts, chlamydia, gonorrhea, syphilis, trichomoniasis), HIV (Human Immunodeficiency Virus), cancer, type I diabetes, type II diabetes, chronic kidney disease.

    • Women having any genital surgery including removal of one or both ovaries, uterus or cervix.

    • Women whose menopause occurred by surgical operation (hysterectomy, oophorectomy), or drug/treatment (eg. chemotherapy, radiation therapy).

    • Women using douches daily or weekly.

    • Women who use on a regular basis one of the following: metformin, antihistamines, antidepressants, corticosteroids, boric acid, laxatives, antifungal/antimycotic medication.

    • Women using any oral or vaginal prebiotics, probiotics, or antibiotics in the past 6 months.

    • Women who take progestin-only medicines including progestin-only HRT.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • FemTec Health Inc.

    Investigators

    • Principal Investigator: Kimberly Capone, PhD, FemTec Health Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    FemTec Health Inc.
    ClinicalTrials.gov Identifier:
    NCT05122065
    Other Study ID Numbers:
    • MENO0721
    First Posted:
    Nov 16, 2021
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by FemTec Health Inc.
    vaginal microbiome
    menopause
    hormone replacement therapy
    Genitourinary syndrome of menopause
    Additional relevant MeSH terms:
    Syndrome

    Study Results

    No Results Posted as of Nov 24, 2021