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NCT05122065

Menopausal Vaginal Microbiome

NCT ID: NCT05122065

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

432 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause Hormone Replacement Therapy Genitourinary Syndrome of Menopause

Keywords

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vaginal microbiome menopause hormone replacement therapy Genitourinary syndrome of menopause

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

No interventions assigned to this group

Asymptomatic/HRT

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

No interventions assigned to this group

GSM/non-HRT

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

No interventions assigned to this group

GSM/HRT

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Capone, PhD

Role: PRINCIPAL_INVESTIGATOR

FemTec Health Inc.

Central Contacts

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Malcolm Bohm

Role: CONTACT

Phone: +19739753784

Email: [email protected]

Eleni Rizou, PhD

Role: CONTACT

Email: [email protected]

References

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Farage MA, Miller KW, Sobel JD. Dynamics of the vaginal ecosystem - hormonal influences. Infectious Diseases: Research and Treatment. 2010. doi: 10.4137/IDRT.S3903

Reference Type BACKGROUND

Gliniewicz K, Schneider GM, Ridenhour BJ, Williams CJ, Song Y, Farage MA, Miller K, Forney LJ. Comparison of the Vaginal Microbiomes of Premenopausal and Postmenopausal Women. Front Microbiol. 2019 Feb 14;10:193. doi: 10.3389/fmicb.2019.00193. eCollection 2019.

Reference Type BACKGROUND

PMID: 30837959 (View on PubMed)

Muhleisen AL, Herbst-Kralovetz MM. Menopause and the vaginal microbiome. Maturitas. 2016 Sep;91:42-50. doi: 10.1016/j.maturitas.2016.05.015. Epub 2016 Jun 1.

Reference Type BACKGROUND

PMID: 27451320 (View on PubMed)

Angelou K, Grigoriadis T, Diakosavvas M, Zacharakis D, Athanasiou S. The Genitourinary Syndrome of Menopause: An Overview of the Recent Data. Cureus. 2020 Apr 8;12(4):e7586. doi: 10.7759/cureus.7586.

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PMID: 32399320 (View on PubMed)

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Reference Type BACKGROUND

PMID: 27716751 (View on PubMed)

Nguyen TM, Do TTT, Tran TN, Kim JH. Exercise and Quality of Life in Women with Menopausal Symptoms: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2020 Sep 26;17(19):7049. doi: 10.3390/ijerph17197049.

Reference Type BACKGROUND

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MENO0721

Identifier Type: -

Identifier Source: org_study_id

Menopausal Vaginal Microbiome

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Asymptomatic/non-HRT

Asymptomatic/HRT

GSM/non-HRT

GSM/HRT

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

FemTec Health Inc.

Responsible Party

Principal Investigators

Kimberly Capone, PhD

Central Contacts

Malcolm Bohm

Eleni Rizou, PhD

References

Farage MA, Miller KW, Sobel JD. Dynamics of the vaginal ecosystem - hormonal influences. Infectious Diseases: Research and Treatment. 2010. doi: 10.4137/IDRT.S3903

Gliniewicz K, Schneider GM, Ridenhour BJ, Williams CJ, Song Y, Farage MA, Miller K, Forney LJ. Comparison of the Vaginal Microbiomes of Premenopausal and Postmenopausal Women. Front Microbiol. 2019 Feb 14;10:193. doi: 10.3389/fmicb.2019.00193. eCollection 2019.

Muhleisen AL, Herbst-Kralovetz MM. Menopause and the vaginal microbiome. Maturitas. 2016 Sep;91:42-50. doi: 10.1016/j.maturitas.2016.05.015. Epub 2016 Jun 1.

Angelou K, Grigoriadis T, Diakosavvas M, Zacharakis D, Athanasiou S. The Genitourinary Syndrome of Menopause: An Overview of the Recent Data. Cureus. 2020 Apr 8;12(4):e7586. doi: 10.7759/cureus.7586.

Lobo RA. Hormone-replacement therapy: current thinking. Nat Rev Endocrinol. 2017 Apr;13(4):220-231. doi: 10.1038/nrendo.2016.164. Epub 2016 Oct 7.

Nguyen TM, Do TTT, Tran TN, Kim JH. Exercise and Quality of Life in Women with Menopausal Symptoms: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2020 Sep 26;17(19):7049. doi: 10.3390/ijerph17197049.

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Other Identifiers

MENO0721