An Open-label, Prospective, Multicentric, Single-arm,Phase IV Study to Assess the Efficacy and Safety ofLevonorgestrel Intrauterine System (Emily) in Indian Womenwith Dysfunctional Uterine Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- (2)To assess the acceptability rate of LNG-IUS (Emily)
研究概览
简要总结
Dysfunctional uterine bleeding (DUB) or menorrhagia is one of themost frequent reasons for gynecological consultation. One in 20 women (aged30–49 years) has menorrhagia which accounts for 12% of all gynecologicalreferrals. Treatment options include oral contraceptives, progestin, non‑steroidalanti‑inflammatory drugs or surgical procedures such as hysterectomy,endometrial resection and laser ablation. Many of the drugs are associated withunpleasant side effects and the various operative procedures are associatedwith inherent risks. The Levonorgestrel (LNG) releasing intra uterine system (IUS)has a strong antiproliferative effect on the endometrium with resultant reductionin blood loss during menstruation. The LNG containing IUS (EMILY) is similar toother IUS in the market which has been shown to be effective in achievingreduction in menstrual blood loss. The present study is an open-label, prospective, multicentric, single-arm,study to assess the efficacy and safety of Levonorgestrel Intrauterine System(Emily) in 75 Indian women with DUB. The primary outcome measures will be toassess the efficacy of the LNG-IUS(Emily) in terms of thereduction of menstrual blood loss and the overall acceptance rate. The secondary outcome measures willbe to assess subject satisfaction from improvement in the quality of life usingEQ-5D-3L QOL questionnaire and to assess the safety of the LNG-IUS (Emily).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian women >30 and <50 years of age suffering from DUB
- •Married and having at least one normal living child
- •Must be having a history of excessive menstrual bleeding for a minimum of last 3 cycles (as evidenced by a baseline Pictorial Blood Assessment Chart [PBAC] score1 of 100 or more)
- •Not using any other hormonal method of contraception
- •Willing to use IUS for the treatment of DUB
- •Must be willing to give written informed consent and comply with the study procedures
- •Expect to continue living in an area accessible to the study center for the duration of the study.
排除标准
- •Known or suspected pregnancy
- •Last delivery or abortion within the past 3 months
- •Intermenstrual bleeding
- •Postmenopausal bleeding (bleeding after more than one year from the last menstrual period)
- •Demonstrable pathological cause for DUB including pelvic inflammatory disease and untreated acute cervicitis or vaginitis
- •Congenital abnormality of the uterus
- •Abnormal PAP smear report
- •Presence of diabetes mellitus (subjects with a random blood sugar [RBS] level above 200 mg/dL)
- •Uncontrolled hypertension defined as BP _140/90 mm Hg in a supine position after resting for 15 minutes)
- •History or presence of incapacitating migraine
- •History of cerebrovascular disease and coronary artery disease
- •Known or suspected tumors of liver, kidney, ovary, uterus, cervix and breast
- •History of thrombophlebitis or thromboembolism in the past
- •On any prohibited medication (hepatotoxic drugs, herbal or ayurvedic products) during the past one month
- •On immunosuppressive treatment
- •Thyroid Stimulating Hormone (TSH) levels <0.4 IU/mL and >7 IU/mL.
结局指标
主要结局
(2)To assess the acceptability rate of LNG-IUS (Emily)
时间窗: 6 months
(1)To assess the efficacy of Levonorgestrel Intrauterine System (LNG-IUS) (Emily) in terms of the reduction of menstrual blood loss in Indian women with Dysfunctional Uterine Bleeding (DUB)
时间窗: 6 months
次要结局
- (3)To assess subject satisfaction from improvement in the quality of life using EQ-5D-3L Quality Of Life (QOL) Questionnaire((4)To assess the safety of LNG-IUS (Emily))