Vaginal Inflammation Markers in Postmenopausal Women With and Without Symptoms of Vaginal Inflammation

This study has been completed.
Sponsor:
Collaborator:
Eastern Virginia Medical School
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01899612
First received: July 10, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

Many postmenopausal women suffer from vaginal symptoms such as dryness, itching, and painful intercourse. The underlying pathology is unknown. Since symptoms are comparable to those found in infectious vaginitis during the reproductive life stage, the investigators hypothesize that the vaginal milieu in symptomatic postmenopausal women is comparable to inflammation in vaginitis. The investigators therefore study vaginal cytokines in symptomatic and asymptomatic postmenopausal women.


Condition
Menopause
Vaginal Atrophy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Vaginal Cytokines in Postmenopausal Women With Symptoms of Vulvovaginal Irritation

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Difference in total vaginal IL-1beta in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation. [ Time Frame: At enrolment (expected to be 2 weeks after screening) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in total vaginal IL-6 in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation. [ Time Frame: At enrolment (expected to be 2 weeks after screening) ] [ Designated as safety issue: No ]
  • Difference in total vaginal IL-8 in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation. [ Time Frame: At enrolment (expected to be 2 weeks after screening) ] [ Designated as safety issue: No ]
  • Difference in total vaginal TNF-alpha in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation. [ Time Frame: At enrolment (expected to be 2 weeks after screening) ] [ Designated as safety issue: No ]
  • Difference in vaginal leukocyte counts in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation. [ Time Frame: At enrolment (expected to be 2 weeks after screening) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

vaginal lavage, serum


Enrollment: 16
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Symptomatic postmenopausal women
Postmenopausal women with vulvovaginal symptoms
Asymptomatic postmenopausal women
Postmenopausal women without vulvovaginal symptoms

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All subjects will be recruited at the menopause center, Inselspital Berne.

Criteria

Inclusion Criteria:

  • Age of 40 years or older
  • At least 1 year history of amenorrhea
  • Normal Pap smear within the past year
  • Willingness to abstain from sexual intercourse and use of over-the-counter vaginal products for 7 days before the collection of vaginal samples
  • Written informed consent.

Exclusion Criteria

  • Administration of any form of oral hormone replacement therapy within 2 months, transdermal or vaginal hormone replacement therapy for 1 months prior to entry into the study
  • Active vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis based on vaginal wet prep, pH, whiff test and KOH preparation;
  • Untreated cervical, vaginal or vulvar intraepithelial neoplasia;
  • Active sexually transmitted diseases including herpes simplex viral infection, gonorrhea and Chlamydia
  • Pessary-users
  • Active treatment with tamoxifen, raloxifene or other forms of selective estrogen receptor modulators (SERMs);
  • Undiagnosed vaginal bleeding
  • Hysterectomy
  • Past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism
  • Immunocompromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899612

Locations
Switzerland
Menopause Clinic, Women's Hospital, Inselspital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Eastern Virginia Medical School
Investigators
Principal Investigator: Petra Stute, MD Inselspital Bern Switzerland
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01899612     History of Changes
Other Study ID Numbers: 58/10
Study First Received: July 10, 2013
Last Updated: July 10, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
menopause
vaginal atrophy
cytokine
IL-1beta
IL-6
IL-8
TNF-alpha

Additional relevant MeSH terms:
Atrophy
Vaginitis
Genital Diseases, Female
Pathological Conditions, Anatomical
Vaginal Diseases

ClinicalTrials.gov processed this record on October 20, 2014