NCT01741948

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

November 23, 2012

Last Update Submit

February 9, 2015

Conditions

Vestibulodynia

Keywords

Provoked vestibulodyniaHormonal contraceptives

Outcome Measures

Primary Outcomes (1)

  • Prevalence of hormonal-contraceptive induced provoked vestibulodynia

    one year for patients' enrollment and another year for follow up.

    One year

Secondary Outcomes (3)

  • Hormonal contraceptive components associated with higher risk of HCs induced PVD

    One year

  • Clinical factors associated with HCs induced PVD

    One year

  • Biochemical markers associated with higher risk of HCs induced PVD

    One year

Study Arms (1)

First time users of hormonal contraceptive

Drug: Hormonal contraceptive

Interventions

Hormonal contraceptiveDRUG

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.

First time users of hormonal contraceptive

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clalit health Services

Jerusalem, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (12)

  • Goldstein A, Burrows L, Goldstein I. Can oral contraceptives cause vestibulodynia? J Sex Med. 2010 Apr;7(4 Pt 1):1585-7. doi: 10.1111/j.1743-6109.2009.01685.x. Epub 2010 Jan 25.

    PMID: 20102483BACKGROUND

  • Greenstein A, Ben-Aroya Z, Fass O, Militscher I, Roslik Y, Chen J, Abramov L. Vulvar vestibulitis syndrome and estrogen dose of oral contraceptive pills. J Sex Med. 2007 Nov;4(6):1679-83. doi: 10.1111/j.1743-6109.2007.00621.x.

    PMID: 17970976BACKGROUND

  • Bohm-Starke N, Johannesson U, Hilliges M, Rylander E, Torebjork E. Decreased mechanical pain threshold in the vestibular mucosa of women using oral contraceptives: a contributing factor in vulvar vestibulitis? J Reprod Med. 2004 Nov;49(11):888-92.

    PMID: 15603099BACKGROUND

  • Bouchard C, Brisson J, Fortier M, Morin C, Blanchette C. Use of oral contraceptive pills and vulvar vestibulitis: a case-control study. Am J Epidemiol. 2002 Aug 1;156(3):254-61. doi: 10.1093/aje/kwf037.

    PMID: 12142260BACKGROUND

  • Sjoberg I, Nylander Lundqvist EN. Vulvar vestibulitis in the north of Sweden. An epidemiologic case-control study. J Reprod Med. 1997 Mar;42(3):166-8.

    PMID: 9109085BACKGROUND

  • Bazin S, Bouchard C, Brisson J, Morin C, Meisels A, Fortier M. Vulvar vestibulitis syndrome: an exploratory case-control study. Obstet Gynecol. 1994 Jan;83(1):47-50.

    PMID: 8272306BACKGROUND

  • Johannesson U, Sahlin L, Masironi B, Hilliges M, Blomgren B, Rylander E, Bohm-Starke N. Steroid receptor expression and morphology in provoked vestibulodynia. Am J Obstet Gynecol. 2008 Mar;198(3):311.e1-6. doi: 10.1016/j.ajog.2007.09.041. Epub 2008 Feb 21.

    PMID: 18177837BACKGROUND

  • Johannesson U, Sahlin L, Masironi B, Rylander E, Bohm-Starke N. Steroid receptor expression in the vulvar vestibular mucosa--effects of oral contraceptives and menstrual cycle. Contraception. 2007 Oct;76(4):319-25. doi: 10.1016/j.contraception.2007.06.014. Epub 2007 Aug 28.

    PMID: 17900445BACKGROUND

  • Johannesson U, Blomgren B, Hilliges M, Rylander E, Bohm-Starke N. The vulval vestibular mucosa-morphological effects of oral contraceptives and menstrual cycle. Br J Dermatol. 2007 Sep;157(3):487-93. doi: 10.1111/j.1365-2133.2007.08066.x. Epub 2007 Jul 11.

    PMID: 17627793BACKGROUND

  • Eva LJ, MacLean AB, Reid WM, Rolfe KJ, Perrett CW. Estrogen receptor expression in vulvar vestibulitis syndrome. Am J Obstet Gynecol. 2003 Aug;189(2):458-61. doi: 10.1067/s0002-9378(03)00365-x.

    PMID: 14520218BACKGROUND

  • Harlow BL, Vitonis AF, Stewart EG. Influence of oral contraceptive use on the risk of adult-onset vulvodynia. J Reprod Med. 2008 Feb;53(2):102-10.

    PMID: 18357801BACKGROUND

  • Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.

    PMID: 12744420BACKGROUND

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.

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ahinoam LevSagie, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2012

First Posted

December 5, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

IL(2)