Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02415868
• Date of registration: 09/04/2015
• Prospective Registration: Yes
• Primary sponsor: Kimberly-Clark Corporation
• Public title: Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women FLORA
• Scientific title: Development of an Ex-vivo High-throughput Screening Assay for the Vaginal Microbiota of Post-menopausal Women
• Date of first enrolment: December 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415868
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Ellen Klinkert, MD
• Affiliation: Department of Gynaecology, University Medical Center Groningen

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Agree to study design (signed informed consent)

2. Post-menopausal women

3. Vaginal pH =4.5 or pH =5.5

4. At least 12 months of amenorrhea

5. Age =45 and =75

6. Currently in a mutually monogamous sexual relationship or not sexually active;

7. Sexually abstinent 48 hours prior to visit.

8. Willing and capable of following all study instructions; and

9. Good general health.

Exclusion Criteria:

1. Vaginal pH between >4.5 and <5.5

2. Use of topical estrogen containing product 1 week prior to enrollment

3. Use of vaginal lubricants, douches, or any products applied vaginally during the week
prior to the first visit

4. Use of systemic estrogen therapy or products 6 months prior to inclusion

5. Use of a vaginal pessary during the week prior to the visit

6. Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week)

7. Drug usage within past 2 years

8. A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or
radiation therapy

9. A medical condition which might compromise immune system functions (such as cancer,
leucopenia, HIV-positive, or organ transplant)

10. Antibiotics and/or anti-fungal medication use within the last four (4) weeks

11. Induced menopause due to surgical or medical interventions, such as bilateral
oophorectomy, hysterectomy, chemotherapy or radiation treatment

12. 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

13. Individuals with a sexually transmitted disease (self-reported or detected by the
Principal Investigator)

14. 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

15. 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.



Age minimum: 45 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Postmenopausal Syndrome

Primary Outcome(s)

Characterization of the microbiota [Time Frame: 0 hours]

Secondary ID(s)

500-14-0004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NIZO Food Research

University Medical Center Groningen