Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia- A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Prevalence of hormonal-contraceptive induced provoked vestibulodynia
研究概览
简要总结
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.
详细描述
Background:
Provoked vestibulodynia (PVD), previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort, confined to the vulvar vestibule, in response to contact or pressure. As a result, women with PVD experience pain on sexual intercourse, and many patients also have pain in response to non-sexual activities. The actual prevalence of PVD is unknown, but current evidence indicates that the lifetime cumulative incidence of vulvodynia approaches 15%. Currently, PVD is thought to be the leading cause of dyspareunia in premenopausal women. Once a woman with PVD develops the syndrome, symptoms may last for years; as a result, PVD has a profound effect on women's sexuality and psychological well-being.
The diagnosis of PVD is usually made by assessing for the presence of the modified Friedrich's criteria. These criteria consist of 1) a history of vulvar pain, dyspareunia or pain with tampon insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator, and 3) no other identifiable cause for the pain (such as vaginitis, dermatitis etc.).
The etiology of this condition remains unknown. Proposed causes include chronic inflammation, peripheral neuropathy, genetic, immunologic and\or hormonal factors, infection, psychological disorders, sexual dysfunction, or disturbance in the central nervous system.
Several studies have demonstrated an increased risk of developing PVD secondary to hormonal contraceptive (HC) usage. The relative risk of developing PVD seems to rise with an increased duration of HCs use (at least up to 2-4 years of use), first use of HCs at a young age (<16 years), and the hormonal composition of HCs, specifically the progestogenic, estrogenic, and androgenic potency of the pills.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
First time users of hormonal contraceptive
干预措施: Hormonal contraceptive (Drug)
结局指标
主要结局
Prevalence of hormonal-contraceptive induced provoked vestibulodynia
时间窗: One year
one year for patients' enrollment and another year for follow up.
次要结局
- Hormonal contraceptive components associated with higher risk of HCs induced PVD(One year)
- Biochemical markers associated with higher risk of HCs induced PVD(One year)
- Clinical factors associated with HCs induced PVD(One year)
研究者
ahinoam lev sagie
Principal Investigator
Clalit Health Services
