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

NCT01899612 | Completed

• 1 other identifier: 58/10
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Menopause; Vaginal Atrophy

Keywords

menopause; vaginal atrophy; cytokine; IL-1beta; IL-6; IL-8; TNF-alpha

Outcome Measures

Primary Outcomes (1)

• Difference in total vaginal IL-1beta in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation.

  At enrolment (expected to be 2 weeks after screening)

Secondary Outcomes (4)

• Difference in total vaginal IL-6 in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation.

  At enrolment (expected to be 2 weeks after screening)

• Difference in total vaginal IL-8 in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation.

  At enrolment (expected to be 2 weeks after screening)

• Difference in total vaginal TNF-alpha in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation.

  At enrolment (expected to be 2 weeks after screening)

• Difference in vaginal leukocyte counts in postmenopausal patients symptomatic, and asymptomatic of vulvovaginal irritation.

  At enrolment (expected to be 2 weeks after screening)

Study Arms (2)

Symptomatic postmenopausal women

Postmenopausal women with vulvovaginal symptoms

Asymptomatic postmenopausal women

Postmenopausal women without vulvovaginal symptoms

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Eastern Virginia Medical School: collaborator

Study Sites (1)

Menopause Clinic, Women's Hospital, Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (4)

• Notelovitz M, Mattox JH. Suppression of vasomotor and vulvovaginal symptoms with continuous oral 17beta-estradiol. Menopause. 2000 Sep-Oct;7(5):310-7. doi: 10.1097/00042192-200007050-00005.

  PMID: 10993030 BACKGROUND

• Al-Harthi L, Wright DJ, Anderson D, Cohen M, Matity Ahu D, Cohn J, Cu-Unvin S, Burns D, Reichelderfer P, Lewis S, Beckner S, Kovacs A, Landay A. The impact of the ovulatory cycle on cytokine production: evaluation of systemic, cervicovaginal, and salivary compartments. J Interferon Cytokine Res. 2000 Aug;20(8):719-24. doi: 10.1089/10799900050116426.

  PMID: 10954915 BACKGROUND

• Franklin RD, Kutteh WH. Characterization of immunoglobulins and cytokines in human cervical mucus: influence of exogenous and endogenous hormones. J Reprod Immunol. 1999 Mar;42(2):93-106. doi: 10.1016/s0165-0378(98)00086-2.

  PMID: 10221733 BACKGROUND

• Kollmann Z, Bersinger N, von Wolff M, Thurman AR, Archer DF, Stute P. Vaginal cytokines do not correlate with postmenopausal vulvovaginal symptoms. Gynecol Endocrinol. 2015 Apr;31(4):317-21. doi: 10.3109/09513590.2014.995080. Epub 2015 Jan 5.

  PMID: 25559048 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

vaginal lavage, serum

Study Officials

• Petra Stute, MD

  Inselspital Bern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 15, 2013
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

CH (1)