Postmenopausal SyndromeFLORANCT02415868
Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women
An observational study of Postmenopausal Syndrome, run by Kimberly-Clark Corporation at 1 site in Netherlands.
Trial summary
This purpose of this study is to collect vaginal microbial samples of postmenopausal women to assess the optimal conditions for cultivation and storage of the vaginal microbiota. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Syndrome
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2015to Feb 2016
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post-menopausal women
Who may be able to join
- Agree to study design (signed informed consent)
- Post-menopausal women
- Vaginal pH ≤4.5 or pH ≥5.5
- At least 12 months of amenorrhea
- Age ≥45 and ≤75
- Currently in a mutually monogamous sexual relationship or not sexually active;
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- Sexually abstinent 48 hours prior to visit.
- Willing and capable of following all study instructions; and
- Good general health.
Who cannot join
- Vaginal pH between >4.5 and <5.5
- Use of topical estrogen containing product 1 week prior to enrollment
- Use of vaginal lubricants, douches, or any products applied vaginally during the week prior to the first visit
- Use of systemic estrogen therapy or products 6 months prior to inclusion
- Use of a vaginal pessary during the week prior to the visit
- Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week)
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- Drug usage within past 2 years
- A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
- A medical condition which might compromise immune system functions (such as cancer, leucopenia, HIV-positive, or organ transplant)
- Antibiotics and/or anti-fungal medication use within the last four (4) weeks
- Induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment
- Currently diagnosed with or being treated for a genital infection or urinary tract infection, subjects who had any vaginal infection one month prior to the screening will be excluded
- Individuals with a sexually transmitted disease (self-reported or detected by the Principal Investigator)
- At enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Participation in a clinical trial involving an investigational product/device within the past three months; subjects who are scheduled to participate in another clinical study concurrently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women
This purpose of this study is to collect vaginal microbial samples of postmenopausal women to assess the optimal conditions for cultivation and storage of the vaginal microbiota. These samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal microbial community of postmenopausal women. This assay will be used to select and screen compounds that can affect the vaginal microbiota and subsequently affect related symptoms such as vaginal dryness.
Read the detailed description
Vaginal swabs will be collected from post-menopausal women (5 women vaginal pH ≤4.5 and 5 women with vaginal pH≥5.5), aged 45 - 75, with at least 12 months of amenorrhea. Enough women will be screened to ensure five women for each pH range.
Using a speculum, the mid lateral vaginal wall is made visible, samples will be collected by the physician or nurse using a flocked swab. After collection, vaginal swabs will be stored immediately in adequate liquid medium at 4ºC and will be transported to the lab within 7 hours after sampling for further storage and culture of the material.
The vaginal microbiota of post-menopausal women with a vaginal pH of ≤ 4.5 and ≥ 5.5 will be characterized and compared using 16S ribosomal ribonucleic acid (rRNA) sequencing. In additional, optimal conditions for cultivation and storage of the vaginal microbiota will be examined for use in assays mimicking the vaginal microbial community of postmenopausal women.
- Conditions
- Postmenopausal Syndrome
- Keywords
- Vaginal Microbiota
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 |
|---|---|---|
| Low pH | Post Menopausal women with vaginal pH of 4.5 or below | |
| High pH | Post Menopausal women with vaginal pH of 5.5 or above |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the microbiota
By 16s rRNA sequencing
Measured: 0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NIZO Food Research, University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Ellen Klinkert, MD, Principal investigator, Department of Gynaecology, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415868
- Sponsor's protocol ID
- 500-14-0004
- Acronym
- FLORA
- Status last verified
- Feb 2016
- First submitted
- 9 Apr 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chaban B, Links MG, Jayaprakash TP, Wagner EC, Bourque DK, Lohn Z, Albert AY, van Schalkwyk J, Reid G, Hemmingsen SM, Hill JE, Money DM. Characterization of the vaginal microbiota of healthy Canadian women through the menstrual cycle. Microbiome. 2014 Jul 4;2:23. doi: 10.1186/2049-2618-2-23. eCollection 2014.
PubMed 25053998Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.
PubMed 22073175
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women
- ClinicalTrials.gov ID
- NCT02415868
- Acronym / sponsor ID
- FLORA / 500-14-0004
- Conditions
- Postmenopausal Syndrome
- Keywords
- Vaginal Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Collaborators
- NIZO Food Research, University Medical Center Groningen
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
This purpose of this study is to collect vaginal microbial samples of postmenopausal women to assess the optimal conditions for cultivation and storage of the vaginal microbiota. These samples will subsequently be used to develop a high-throughput assay that mimicks the vaginal microbial community of postmenopausal women. This assay will be used to select and screen compounds that can affect the vaginal microbiota and subsequently affect related symptoms such as vaginal dryness.
Detailed description
Vaginal swabs will be collected from post-menopausal women (5 women vaginal pH ≤4.5 and 5 women with vaginal pH≥5.5), aged 45 - 75, with at least 12 months of amenorrhea. Enough women will be screened to ensure five women for each pH range.
Using a speculum, the mid lateral vaginal wall is made visible, samples will be collected by the physician or nurse using a flocked swab. After collection, vaginal swabs will be stored immediately in adequate liquid medium at 4ºC and will be transported to the lab within 7 hours after sampling for further storage and culture of the material.
The vaginal microbiota of post-menopausal women with a vaginal pH of ≤ 4.5 and ≥ 5.5 will be characterized and compared using 16S ribosomal ribonucleic acid (rRNA) sequencing. In additional, optimal conditions for cultivation and storage of the vaginal microbiota will be examined for use in assays mimicking the vaginal microbial community of postmenopausal women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pH | – | –Post Menopausal women with vaginal pH of 4.5 or below |
| High pH | – | –Post Menopausal women with vaginal pH of 5.5 or above |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal women
Key inclusion criteria (9 listed)
- Agree to study design (signed informed consent)
- Post-menopausal women
- Vaginal pH ≤4.5 or pH ≥5.5
- At least 12 months of amenorrhea
- Age ≥45 and ≤75
Key exclusion criteria (15 listed)
- Vaginal pH between >4.5 and <5.5
- Use of topical estrogen containing product 1 week prior to enrollment
- Use of vaginal lubricants, douches, or any products applied vaginally during the week prior to the first visit
- Use of systemic estrogen therapy or products 6 months prior to inclusion
- Use of a vaginal pessary during the week prior to the visit
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
Characterization of the microbiota
Time frame: 0 hours
By 16s rRNA sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Background: PubMed 25053998Chaban B, Links MG, Jayaprakash TP, Wagner EC, Bourque DK, Lohn Z, Albert AY, van Schalkwyk J, Reid G, Hemmingsen SM, Hill JE, Money DM. Characterization of the vaginal microbiota of healthy Canadian women through the menstrual cycle. Microbiome. 2014 Jul 4;2:23. doi: 10.1186/2049-2618-2-23. eCollection 2014.
- Background: PubMed 22073175Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.
- 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.
Ellen Klinkert, MD principal investigator
Department of Gynaecology, University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Syndrome, run by Kimberly-Clark Corporation at 1 site in Netherlands.
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the microbiota (time frame: 0 hours). 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 NCT02415868, which also lists 2 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 23 Feb 2016.