Menopausal Vaginal Microbiome

Menopause Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05122065
• Other study ID #: MENO0721
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2021
• Source: FemTec Health Inc.
• Contact: Malcolm Bohm
• Phone: +19739753784
• Email: malcolm[@]liquidgrids.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 432
• Est. completion date: December 15, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Hormone Replacement Therapy
• Menopause
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FemTec Health Inc.

References & Publications (57)

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic questionnaire	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
Secondary	Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire	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
Secondary	Menopause Rating Scale (MRS) questionnaire	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
Secondary	Brief Resilience Scale (BRS) questionnaire	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
Secondary	Vaginal pH -at home test kit	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
Secondary	Facial Skin Type Test	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
Secondary	Body Hydration Test	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