Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ahinoam lev sagie
• Collaborator: Hadassah Medical Organization
• Treatments: Contraceptive Agents

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