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Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia

NCT01741948 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-02-10

No results posted yet for this study

Summary

There have been reports in the medical literature demonstrating a link between the development of provoked vestibulodynia (PVD), a sexual pain disorder, and hormonal contraceptive (HC) use. The purpose of this pilot study is to assess the prevalence of HCs induced PVD among a HC naïve population, to evaluate which of the components of the HCs are associated with a higher risk of the development of PVD, and to evaluate which clinical and genetic factors predispose the patient to HCs induced PVD. Assessments will be made through patient questionnaires, physical examinations, and blood tests. Microarray techniques will be employed to characterize, on a global level, the gene expression profiles of women who develop PVD in comparison to those who do not develop PVD. Patients will be followed for a year. Results will be used to develop a larger clinical trial.

Conditions

  • Vestibulodynia

Interventions

DRUG

Hormonal contraceptive

The study will follow patients who are first time users of HCs for a full year after initiation. Patients will be followed every 3 months via questionnaires, blood examinations, and gynecologic examination, in case dyspareunia evolves. First appointment (before initiation of HCs): Questionnaire FSFI (Female Sexual Function Index) questionnaire. Blood collection for hormones levels and extraction of mononuclear blood cells. A gynecologic exam intended to rule out existing problem which causing dyspareunia. 3,6,9,and 12 months after initiation of HCs or anytime if a patient has dyspareunia: Questionnaire evaluating possible influence of HCs use (dyspareunia, lubrication and libido). FSFI questionnaire. Blood collection Gynecologic examination, designated to assess the cause of pain, including assessment of vestibular tenderness, muscle tightness and tenderness, pressure-pain thresholds measurement using vulvar algesiometer, pH measurement and vaginal swab for microscopy.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • ahinoam lev sagie

    lead OTHER

Principal Investigators

  • Ahinoam LevSagie, MD · Clalit Health Services

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01741948 on ClinicalTrials.gov