MenopauseNCT05122065
Menopausal Vaginal Microbiome
An observational study of Menopause and Hormone Replacement Therapy, run by FemTec Health Inc..
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hormone Replacement Therapy, Genitourinary Syndrome of Menopause
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be postmenopausal women with or without self-reported GSM that either follow or do not follow an HRT plan.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
Eleni Rizou, PhD contact
About this study
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
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.
- Keywords
- vaginal microbiome, menopause, hormone replacement therapy, Genitourinary syndrome of menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FemTec Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Capone, PhD, Principal investigator, FemTec Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122065
- Sponsor's protocol ID
- MENO0721
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30837959Muhleisen 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.
PubMed 27451320Angelou 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.
PubMed 32399320Lobo 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.
PubMed 27716751Nguyen 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.
PubMed 32993147Gloor GB, Macklaim JM, Pawlowsky-Glahn V, Egozcue JJ. Microbiome Datasets Are Compositional: And This Is Not Optional. Front Microbiol. 2017 Nov 15;8:2224. doi: 10.3389/fmicb.2017.02224. eCollection 2017.
PubMed 29187837Hillmann B, Al-Ghalith GA, Shields-Cutler RR, Zhu Q, Gohl DM, Beckman KB, Knight R, Knights D. Evaluating the Information Content of Shallow Shotgun Metagenomics. mSystems. 2018 Nov 13;3(6):e00069-18. doi: 10.1128/mSystems.00069-18. eCollection 2018 Nov-Dec.
PubMed 30443602Yang Q, Wang Y, Wei X, Zhu J, Wang X, Xie X, Lu W. The Alterations of Vaginal Microbiome in HPV16 Infection as Identified by Shotgun Metagenomic Sequencing. Front Cell Infect Microbiol. 2020 Jun 23;10:286. doi: 10.3389/fcimb.2020.00286. eCollection 2020.
PubMed 32656096Oliver A, LaMere B, Weihe C, Wandro S, Lindsay KL, Wadhwa PD, Mills DA, Pride DT, Fiehn O, Northen T, de Raad M, Li H, Martiny JBH, Lynch S, Whiteson K. Cervicovaginal Microbiome Composition Is Associated with Metabolic Profiles in Healthy Pregnancy. mBio. 2020 Aug 25;11(4):e01851-20. doi: 10.1128/mBio.01851-20.
PubMed 32843557Feehily C, Crosby D, Walsh CJ, Lawton EM, Higgins S, McAuliffe FM, Cotter PD. Shotgun sequencing of the vaginal microbiome reveals both a species and functional potential signature of preterm birth. NPJ Biofilms Microbiomes. 2020 Nov 12;6(1):50. doi: 10.1038/s41522-020-00162-8.
PubMed 33184260Nappi RE, Martini E, Cucinella L, Martella S, Tiranini L, Inzoli A, Brambilla E, Bosoni D, Cassani C, Gardella B. Addressing Vulvovaginal Atrophy (VVA)/Genitourinary Syndrome of Menopause (GSM) for Healthy Aging in Women. Front Endocrinol (Lausanne). 2019 Aug 21;10:561. doi: 10.3389/fendo.2019.00561. eCollection 2019.
PubMed 31496993Jenabi E, Shobeiri F, Hazavehei SM, Roshanaei G. Assessment of Questionnaire Measuring Quality of Life in Menopausal Women: A Systematic Review. Oman Med J. 2015 May;30(3):151-6. doi: 10.5001/omj.2015.34.
PubMed 26171119Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, Santoro N, Simoncini T. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. doi: 10.1038/nrdp.2015.4.
PubMed 27188659Whiteley J, DiBonaventura Md, Wagner JS, Alvir J, Shah S. The impact of menopausal symptoms on quality of life, productivity, and economic outcomes. J Womens Health (Larchmt). 2013 Nov;22(11):983-90. doi: 10.1089/jwh.2012.3719. Epub 2013 Oct 1.
PubMed 24083674
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05122065
- Acronym / sponsor ID
- MENO0721
- Keywords
- vaginal microbiome, menopause, hormone replacement therapy, Genitourinary syndrome of menopause
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- FemTec Health Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be postmenopausal women with or without self-reported GSM that either follow or do not follow an HRT plan.
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Demographic questionnaire
Time frame: Baseline
Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire
Time frame: Baseline
Menopause Rating Scale (MRS) questionnaire
Time frame: Baseline
Brief Resilience Scale (BRS) questionnaire
Time frame: Baseline
Vaginal pH -at home test kit
Time frame: Baseline
Facial Skin Type Test
Time frame: Baseline
Body Hydration Test
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- BackgroundFarage MA, Miller KW, Sobel JD. Dynamics of the vaginal ecosystem - hormonal influences. Infectious Diseases: Research and Treatment. 2010. doi: 10.4137/IDRT.S3903
- Background: PubMed 30837959Gliniewicz 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.
- Background: PubMed 27451320Muhleisen 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.
- Background: PubMed 32399320Angelou 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.
- Background: PubMed 27716751Lobo 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.
- Background: PubMed 32993147Nguyen 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.
- Background: PubMed 29187837Gloor GB, Macklaim JM, Pawlowsky-Glahn V, Egozcue JJ. Microbiome Datasets Are Compositional: And This Is Not Optional. Front Microbiol. 2017 Nov 15;8:2224. doi: 10.3389/fmicb.2017.02224. eCollection 2017.
- Background: PubMed 30443602Hillmann B, Al-Ghalith GA, Shields-Cutler RR, Zhu Q, Gohl DM, Beckman KB, Knight R, Knights D. Evaluating the Information Content of Shallow Shotgun Metagenomics. mSystems. 2018 Nov 13;3(6):e00069-18. doi: 10.1128/mSystems.00069-18. eCollection 2018 Nov-Dec.
- Background: PubMed 32656096Yang Q, Wang Y, Wei X, Zhu J, Wang X, Xie X, Lu W. The Alterations of Vaginal Microbiome in HPV16 Infection as Identified by Shotgun Metagenomic Sequencing. Front Cell Infect Microbiol. 2020 Jun 23;10:286. doi: 10.3389/fcimb.2020.00286. eCollection 2020.
- Background: PubMed 32843557Oliver A, LaMere B, Weihe C, Wandro S, Lindsay KL, Wadhwa PD, Mills DA, Pride DT, Fiehn O, Northen T, de Raad M, Li H, Martiny JBH, Lynch S, Whiteson K. Cervicovaginal Microbiome Composition Is Associated with Metabolic Profiles in Healthy Pregnancy. mBio. 2020 Aug 25;11(4):e01851-20. doi: 10.1128/mBio.01851-20.
- Background: PubMed 33184260Feehily C, Crosby D, Walsh CJ, Lawton EM, Higgins S, McAuliffe FM, Cotter PD. Shotgun sequencing of the vaginal microbiome reveals both a species and functional potential signature of preterm birth. NPJ Biofilms Microbiomes. 2020 Nov 12;6(1):50. doi: 10.1038/s41522-020-00162-8.
- Background: PubMed 31496993Nappi RE, Martini E, Cucinella L, Martella S, Tiranini L, Inzoli A, Brambilla E, Bosoni D, Cassani C, Gardella B. Addressing Vulvovaginal Atrophy (VVA)/Genitourinary Syndrome of Menopause (GSM) for Healthy Aging in Women. Front Endocrinol (Lausanne). 2019 Aug 21;10:561. doi: 10.3389/fendo.2019.00561. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Rizou, PhD contact
Kimberly Capone, PhD principal investigator
FemTec Health Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Hormone Replacement Therapy, run by FemTec Health Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malcolm Bohm (+19739753784, malcolm@liquidgrids.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal microbiome sample collection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122065, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.