Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia

This study is not yet open for participant recruitment.
Verified December 2012 by Clalit Health Services
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Ahinoam Lev Sagie, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01741948
First received: November 23, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Vestibulodynia
Drug: Hormonal contraceptive

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia- A Prospective Study

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will follow patients who are first time users of HCs for a full year after initiation. Patients will be recruited in a gynecology clinic affiliated with the "Clalit" Health Maintenance Organization in Jerusalem, Israel (Merkaz Briut Haisha, Ramat Eshkol, Jerusalem). This is a primary care government funded clinic, treating a diverse population.

Criteria

Inclusion Criteria:

  • 200 non pregnant women between 18-35 naïve to HCs or other hormonal medications.
  • Patients able to provide Informed Consent and complete questionnaires.
  • Patient intends to use HCs for at least one year.
  • On exam before initiation of HCs, patient does not have primary PVD, pelvic floor hypertonicity, vaginismus or congenital abnormalities.
  • Patient will be available for follow up appointments.
  • Patient is willing to undergo gynecologic examination, if dyspareunia develops.

Exclusion Criteria:

  • Patients with endocrine disturbances (including PCOS), liver diseases and eating disorders.
  • Patients who suffer from Hypertension, Migraine with aura or clotting disturbances.
  • Patients that experience pain with intercourse or tampon insertion.
  • Patients that have other contraindications for HCs use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741948

Contacts
Contact: Ahinoam LevSagie, MD +972-8-9762666 levsagie@netvision.net.il

Locations
Israel
Clalit health Services Not yet recruiting
Jerusalem, Israel
Contact: Ahinoam Lev Sagie, MD    +972-2-5889551 ext 3      
Principal Investigator: Ahinoam Lev Sagie, MD         
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Ahinoam Lav Sagie, MD         
Principal Investigator: Ahinoam Lev Sagie, MD         
Sub-Investigator: Tal Imbar, MD         
Sponsors and Collaborators
Clalit Health Services
Hadassah Medical Organization
Investigators
Principal Investigator: Ahinoam LevSagie, MD Clalit Health Services
  More Information

Publications:

Responsible Party: Ahinoam Lev Sagie, Principal Investigator, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01741948     History of Changes
Other Study ID Numbers: Levsagie OCP PVD
Study First Received: November 23, 2012
Last Updated: December 3, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Provoked vestibulodynia
Hormonal contraceptives

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014