Menopausal Vaginal Microbiome

NCT05122065 | Unknown

• 1 other identifier: MENO0721
• Study Type: observational
• Target: 432
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause; Hormone Replacement Therapy; Genitourinary Syndrome of Menopause

Keywords

vaginal microbiome; menopause; hormone replacement therapy; Genitourinary syndrome of menopause

Outcome Measures

Primary Outcomes (1)

• Vaginal microbiome sample collection

  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 Outcomes (7)

• Demographic questionnaire

  Baseline

• Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire

  Baseline

• Menopause Rating Scale (MRS) questionnaire

  Baseline

• Brief Resilience Scale (BRS) questionnaire

  Baseline

• Vaginal pH -at home test kit

  Baseline

Study Arms (4)

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Women who are females from birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• with formal diagnosis of GSM, or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FemTec Health Inc.: lead

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Study Officials

• Kimberly Capone, PhD

  FemTec Health Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malcolm Bohm

CONTACT

+19739753784; malcolm@liquidgrids.com

Eleni Rizou, PhD

CONTACT

erizou@femtechealth.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: December 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: December 15, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share