Menopausal Vaginal Microbiome

FemTec Health

Status: Unknown

Conditions: Hormone Replacement Therapy; Menopause; Genitourinary Syndrome of Menopause

Study type: Observational

Funder types: Industry

Identifiers

NCT05122065

MENO0721

Details and patient eligibility

About

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.

Enrollment: 432 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

432 participants in 4 patient groups

Asymptomatic/non-HRT

Description:

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

Description:

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

GSM/non-HRT

Description:

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

GSM/HRT

Description:

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