Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
研究概览
简要总结
This study compares two treatments for the management of heavy menstrual bleeding, ulipristal acetate (UPA) and tranexamic acid (TEA), on health-related quality of life. Half of the participants will receive UPA and a placebo, and the other half will receive TEA and a placebo.
详细描述
UPA is approved by Health Canada for the treatment of signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery. UPA is considered investigational for this study, as it has not been approved by Health Canada for the treatment of heavy menstrual bleeding in women who do not have uterine fibroids.
TEA is approved by Health Canada for prevention or reduction of bleeding in different conditions, including heavy periods. This treatment is available as part of routine care for regular heavy menstrual bleeding and is being used as the comparison treatment in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants are female and have a uterus
- •Participants are between the ages of 18 and 51 years at the time of consent
- •Participants have heavy menstrual bleeding as evidenced by their symptoms of subjective increased bleeding volume and desire to seek treatment
- •The symptom of heavy menstrual bleeding has been present for most of the last 6 months
- •Participants have regular menstrual cycles between 24 -38 days in length
排除标准
- •Participants who are pregnant or have a positive urine β-hCG
- •Participants whose bleeding is coming from a cervical, vaginal, urinary or gastrointestinal source
- •Participants who are found to have or who have a previous diagnosis of uterine or cervical polyps, adenomyosis, or leiomyomas (fibroids)
- •Participants who are found to have or who have had endometrial hyperplasia, cervical dysplasia or malignancy of any of the vulva, cervix, endometrium, breast or ovaries.
- •Participants who have ovulatory dysfunction as defined by menstrual cycles that are irregular in frequency and regularity and are often punctuated with periods of amenorrhea
- •Participants who are found to have or who have been diagnosed with a coagulopathy
- •Participants who have a current genitourinary infection
- •Participants who are desirous of becoming pregnant within the next four months
- •Participants who have untreated or inadequately treated thyroid disease
- •Participants who have a contraindication to either treatment including hypersensitivity
- •Participants who are breastfeeding
- •Participants with mild, moderate or severe hepatic impairment
- •Participants with moderate or severe renal impairment
- •Participants with severe asthma not controlled with oral glucocorticoids
- •Participants with active disease, or history of deep vein thrombosis (DVT), pulmonary embolism (PE), cerebral thrombosis or with family history of thromboembolic disease
- •Patients with subarachnoid hemorrhage
- •Patients with acquired disturbances of colour vision
- •Participants who are already on hormone based treatment including, progesterone only pills, combined oral contraceptive pill (COCP), Intrauterine System (IUS)
研究组 & 干预措施
UPA Treatment Group
UPA 5mg capsule daily + Placebo 2 capsules 4 times a day
干预措施: Placebo (for TEA) (Drug)
UPA Treatment Group
UPA 5mg capsule daily + Placebo 2 capsules 4 times a day
干预措施: UPA (Drug)
TEA Treatment Group
TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily
干预措施: TEA (Drug)
TEA Treatment Group
TEA 500mg 2 capsules 4 times a day + Placebo 1 capsule daily
干预措施: Placebo (for UPA) (Drug)
结局指标
主要结局
Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
时间窗: At Baseline and repeated 3 months later
The MMAS measures the impact of menorrhagia on health related quality of life (QoL) in six domains.
次要结局
- Number of adverse events that occur(From Baseline visit to end of study 3 months later)
研究者
Almereau Prollius
M.D.
University of Saskatchewan