Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia- A Prospective Study|
- Prevalence of hormonal-contraceptive induced provoked vestibulodynia [ Time Frame: One year ] [ Designated as safety issue: No ]one year for patients' enrollment and another year for follow up.
- Hormonal contraceptive components associated with higher risk of HCs induced PVD [ Time Frame: One year ] [ Designated as safety issue: No ]Dose of ethinyl estradiol (15, 20 and 30 mcg) The progesterone component
- Clinical factors associated with HCs induced PVD [ Time Frame: One year ] [ Designated as safety issue: No ]Age at menarche Length of use Body mass index
- Biochemical markers associated with higher risk of HCs induced PVD [ Time Frame: One year ] [ Designated as safety issue: No ]Hormones: E2, testosterone Altered gene expression
Biospecimen Retention: Samples Without DNA
Peripheral blood cells will be extracted from all blood samples. mRNA will be purified from all samples. The mRNA will be divided to aliquots and will be frozen in -80°C until further processing after all cohort samples have been collected.
mRNAs will be purified from whole blood using the QIAamp RNA purification kit (Quiagen Germany). A DNase I (Qiagen) digestion step is included in order to eliminate genomic DNA.
Serum will be collected from all blood samples. It will will be frozen in -70°C until further processing after all cohort samples have been collected.
|Study Start Date:||January 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|First time users of hormonal contraceptive||
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01741948
|Clalit health Services|
|Hadassah Medical Organization|
|Principal Investigator:||Ahinoam LevSagie, MD||Clalit Health Services|