Vaginal Prednisone Administration for Prevention of Adrenal Crisis - a Bioequivalence Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Bioequivalence of vaginal prednisone administration compared to rectal application, assessed by repeated determination of prednisolon levels (in blood)
研究概览
简要总结
Patients with chronic adrenal insufficiency need to adapt their glucocorticoid replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), rapid and highly dosed administration of glucocorticoids is crucial. The study is conducted to offer female patients the possibility to perform efficient prednisone self-administration in emergency situations in a way of administration, which is easy to perform and accepted by the patients. Therefore, pharmacokinetics and safety of vaginal prednisone administration will be studied and compared to rectal administration.
详细描述
As patients with adrenal insufficiency still die from adrenal crisis, improvement of both prevention and also emergency management is needed. It is clear that perfect equipment and education of patients is key for further crisis prevention and management. Vaginal administration of prednisone-suppositories is easy to perform and independent of the gastro-intestinal system. Thus, this study aims at the efficacy, feasibility and safety of vaginal administration of prednisone-suppositories.
Recruitment:
Patients with primary adrenal insufficiency will be recruited. The adrenal insufficiency registry of Würzburg comprises more than 150 patients with primary adrenal insufficiency. Several patients have already indicated their interest to participate in the study. According to the European Medicines Agency (EMA) notes for guidance on the investigation of bioavailability and bioequivalence the number of 12 participants is regarded as the minimum required number.
Trial flow:
Pharmacokinetic studies will be performed at two different study visits. Patients will receive a 100mg prednisone suppository (Rectodelt® 100 mg) vaginal and rectal on two different study visits (interval longer then one week). Blood samples for determination of prednisone and adrenocorticotropic Hormone (ACTH) levels will be collected over a time period of 6 hours. Patients receive a diary to document eventual local or systemic adverse events during the following 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with chronic primary adrenal insufficiency due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 6 months)
- •Age ≥ 18 years
- •Patient´s written informed consent
- •Ability to comply with the protocol procedures
- •Established stable replacement therapy, no anticipated change in medication
- •Negative pregnancy test and contraception (besides oral contraceptive pill) in pre-menopausal females
排除标准
- •Diabetes mellitus
- •Infectious disease with fever at time of investigation
- •Known intolerance to the study drug or constituents
- •Oral contraception
- •Pregnancy or breast feeding
- •Renal failure (creatinine >2.5 ULN)
- •Disposition to vaginal mycosis (requiring treatment in the last 6 months or of necessity >2 antimycotic therapies/year)
- •Recurrent urinary tract infections (of necessity >2 antibiosis therapies/year)
研究组 & 干预措施
vaginal administration first
Intervention first visit: vaginal administration of 100mg prednisone suppository, Intervention second visit: rectal administration of 100mg prednisone suppository
干预措施: 100mg prednisone suppository (Drug)
rectal administration first
Intervention first visit: rectal administration of 100mg prednisone suppository, Intervention second visit: vaginal administration 100mg prednisone suppository
干预措施: 100mg prednisone suppository (Drug)
结局指标
主要结局
Bioequivalence of vaginal prednisone administration compared to rectal application, assessed by repeated determination of prednisolon levels (in blood)
时间窗: up to 12 months
The hypothesis is that the same prednisolone levels can be achieved within the same time frame after vaginale administration compared to rectal application.
次要结局
- Safety of the vaginal administration of prednisone compared to rectal application, assessed by the number of participants with treatment-related adverse events (using the NCI-CTC, version 4.0).(up to 12 months)
- Suppressive effects on ACTH levels after vaginal administration of prednisone compared to rectal application, assessed by repeated determination of ACTH-levels(up to 1 week)
- Tolerability by the patients assessed by a questionnaire(up to 1 month)