Status:
COMPLETED
Vaginal Inflammation Markers in Postmenopausal Women With and Without Symptoms of Vaginal Inflammation
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Eastern Virginia Medical School
Conditions:
Menopause
Vaginal Atrophy
Eligibility:
FEMALE
40+ years
Brief Summary
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 infectiou...
Detailed Description
Background Vulvovaginal irritation is a frequent complaint among postmenopausal women who are not on hormone therapy. Common symptoms include pruritus. Patients describe the irritation to be similar ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01899612
Start Date
August 1 2010
End Date
December 1 2012
Last Update
July 15 2013
Active Locations (1)
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1
Menopause Clinic, Women's Hospital, Inselspital Bern
Bern, Switzerland, 3010