Vaginal Bromocriptine for the Treatment of Adenomyosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Objective improvement of adenomyosis
研究概览
简要总结
Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as a therapy based on animal models of the disease and our prior clinical research to observe any objective improvement in the extent of the disease using Magnetic Resonance Imaging (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.
详细描述
Women with adenomyosis proven with MRI will be considered for the intervention with bromocriptine. They will be reassessed at 1, 6 and 9 months. Patients will get a stipend for each visit they complete. The study will end for the enrolled subject at 9th month follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women able to give informed consent and willing and able to attend all study visits
- •Premenopausal women at least 25 years of age
- •No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines
- •MRI or ultrasound imaging consistent or highly suggestive of adenomyosis
- •Use of barrier contraception, sterilization or sexual abstinence
排除标准
- •Women actively trying for pregnancy, currently pregnant, less than six months postpartum or breastfeeding
- •Uterine size > 20 weeks
- •Active pelvic infection or current use of intrauterine contraceptive device
- •Current use of GnRH agonists or antagonists, or contraceptive steroids
- •MRI suggestive of malignant disease of uterus, ovary, or cervix
- •Hypersensitivity to bromocriptine or ergot alkaloids
- •History of gastrointestinal ulcers
- •History of syncope, syncopal migraine or seizure
- •Uncontrolled hypertension
- •History of myocardial infarction, uncontrolled hypertension, heart valve disorder or cerebrovascular accident
- •History of diabetes mellitus except gestational diabetes
- •History of Parkinson's Disease
- •History of psychosis
- •History of pleural or pericardial effusion
- •History of pulmonary fibrosis or thickening of the pleura
- •History of lactose intolerance
- •History of Reynaud's Disease
- •Use of opioid pain medications
研究组 & 干预措施
Vaginal Bromocriptine
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
干预措施: Vaginal Bromocriptine (Drug)
结局指标
主要结局
Objective improvement of adenomyosis
时间窗: 6 months
All patients will get a baseline imaging of the uterus with MRI and a brief procedure, similar to a pap smear, to obtain tissue from the uterus and also a blood draw. Patients will then receive vaginal bromocriptine twice daily and will be reassessed at 6 months with an MRI to see objective improvement in the extent of the disease. This 6 month visit is the only one that would require an in person visit to the research site (Mayo Clinic in this case)
次要结局
- Scores from questionnaires that assess the severity of symptoms from adenomyosis(9 months)