Menopausal Vaginal Microbiome

November 16, 2021 updated by: FemTec Health Inc.

Defining the Vaginal Microbiome and the Vaginal pH of Menopausal Women With and Without Genitourinary Syndrome and With and Without Hormone Replacement Therapy

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants will be postmenopausal women with or without self-reported GSM that either follow or do not follow an HRT plan.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal microbiome sample collection
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic questionnaire
Time Frame: 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.
Baseline
Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire
Time Frame: 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.
Baseline
Menopause Rating Scale (MRS) questionnaire
Time Frame: 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.
Baseline
Brief Resilience Scale (BRS) questionnaire
Time Frame: 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).
Baseline
Vaginal pH -at home test kit
Time Frame: 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.
Baseline
Facial Skin Type Test
Time Frame: 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.
Baseline
Body Hydration Test
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FemTec Health Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

December 15, 2022

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MENO0721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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