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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899612
First Posted: July 15, 2013
Last Update Posted: July 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eastern Virginia Medical School
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  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

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) ]

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) ]
  • 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) ]
  • 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) ]
  • 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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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