Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome

Institut Universitari Dexeus0 个研究点目标入组 15 人开始时间: 2014年2月最近更新: 2017年3月23日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 15
主要终点: Change in dehydroepiandrosterone sulfate (DHEAS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS) involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP), which are generally used to establish the presence of hyperandrogenemia. In general, these levels are obtained during the follicular phase to maintain sampling uniformity and avoid spurious increases due to corpus luteum function. However, because most hyperandrogenic patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to induce withdrawal bleeding and properly time the blood sampling.

Several medications have been described to properly induce withdrawal bleeding , with medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as MPA do not replicate precisely the constellation of biologic activities of the parent hormone and results in a temporary, albeit clinically relevant, suppression in ovarian function and circulating androgen levels , in addition of several adverse side effects .

In this study, it is hypothesized that the administration of natural progesterone vaginally, which will avoid hepatic first pass, may result in significantly less hormonal suppression.

The authors test this hypothesis by prospectively determining the effect of vaginal micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the circulating androgen and 17-OHP levels in women with PCOS.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Chronic ovulatory dysfunction, defined as intermenstrual intervals of >45 days or a total of <8 menstrual cycles per year
•Polycystic ovaries, defined as at least one ovary with >12 follicles between 2 and 9 mm or an ovarian volume >10 mL
•Clinical hyperandrogenism, defined by a Ferriman Gallwey score >8

排除标准

•non-classic congenital adrenal hyperplasia,
•hyperprolactinemia
•thyroid dysfunction
•Oral contraceptives pills taken at least 3 months before the study

研究组 & 干预措施

Micronized Progesterone

Other

Administration of 200 mg of vaginal Micronized Progesterone (100 mg every 12 hours) for a 7-day course

干预措施: Micronized Progesterone (Drug)