Comparison of Estradiol Valerate (E2V), Levonorgestrel- Intrauterine Device (LNG-IUD) and Oral Micronized Progesterone Therapy on Health-related Quality of Life in Premenopausal Women With Heavy Menstrual Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Hot Flush Frequency Total Score (HFRS) Change
研究概览
简要总结
Heavy menstrual bleeding or menorrhagia, is a common problem on women's lives and can burden both patients and health care systems. HMB is defined as cyclic heavy vaginal bleeding. Hormonal treatment of heavy menstrual bleeding (HMB) is also endorsed as the first line treatment in several international guidelines. The effects of these therapies on bleeding related quality of life are not well known. The aim of the present study is compare the effect of Estradiol Valerate/Dienogest (E2V/DNG), Levonorgestrel-Intrauterine Device (LNG-IUD) and oral micronized progesterone treatment on bleeding pattern, cycle control, menopausal symptoms and patient satisfaction of women with HMB.
详细描述
Women who were admitted and treated for HMB were asked to participate in this comparative study. Women were eligible for entry if they had self-described heavy menstrual bleeding, had a regular cycle, had completed their family and were 40-50 years old at initial assessment.
After a thorough physical examination and ultrasonographic evaluation, all women underwent endometrial biopsy before the study by using a Pipelle endometrial suction curette to rule out any organic endometrial pathology. Blood samples were analysed to test for hemoglobin (Hb), hematocrit (Hct), ferritin, serum iron and iron-binding capacity and coagulation tests such as prothrombin time and activated partial thromboplastin time.
The study was approved by the Institutional Review Board and Local Ethics Committee. After they gave written informed consent, patients who fulfilled eligibility criteria were recruited to one of the following 3 groups:
Group 1: Women who were treated with estradiol valerate/dienogest regimen for heavy menstrual bleeding. 28 days of E2V/DNG was administered using a dynamic dosing regimen. (E2V 3 mg on days 1-2, E2V 2 mg/DNG 2 mg on days 3-7, E2V 2 mg/DNG 3 mg on days 8-24, E2V 1 mg on days 25-26 and placebo on days 27-28).
Group 2: Women who were treated with LNG-IUD for heavy menstrual bleeding. LNG-IUD is containing 52 mg levonorgestrel at initial placement and releases 20 microgram levonorgestrel per day. This is approved for 5 years of use by the US FDA for treatment of HMB.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who self described heavy menstrual bleeding
- •women who completed their family
- •have cyclic menstruation
- •40 to 50 years old
排除标准
- •ultrasound abnormalities (submucosal fibroids, intramural fibroids greater than 3 cm in diameter, large subserosal fibroids, endometrial polyps);
- •laboratory abnormalities (follicle-stimulating hormone level higher than 40 iu/l, adverse endometrial histology)
- •hysteroscopic abnormalities (submucosal fibroids, endometrial polyps),
- •incidental adnexal abnormality on ultrasound,
- •severe intermenstrual bleeding, severe dysmenorrhoea, severe premenstrual pain, chronic pelvic pain,
- •medical contraindications to either study treatment,
- •previous endometrial ablation or resection,
- •uninvestigated postcoital bleeding
- •untreated abnormal cervical cytology.
- •pregnancy; lactation; occurrence of <3 menstrual cycles following childbirth, abortion or lactation;
- •current use of an intrauterine device; hypersensitivity to any of the study drug ingredients and known or suspected malignant or premalignant disease.
- •systemic diseases like hypertension, diabetes, thyroid diseases or coronary artery diseases; and history of previous medication for menorrhagia
- •using anticoagulant drugs
结局指标
主要结局
Hot Flush Frequency Total Score (HFRS) Change
时间窗: change from initial hot flush frequency score at 6 months
Hot flush rating scale (HFRS) is a 5 items subjective tool. The first and second items of this scale are for Hot Flush Frequency Score. Women were asked to provide ratings of the frequency of hot flushes and night sweats in the first and second items. The number of the frequency in the first and second item is summed and this score is the total hot flush frequency score. The minimum Hot Flush Frequency Score is 0 and there is no maximum score to provide. However, the higher scores represent worse outcome. In this study, the Hot Flush Frequency Score is measured and recorded at initial of the treatment and six months of treatment. The change between the initial and six months score is our first primer outcome.
Total Menopause Rating Scale (MRS) Score Change
时间窗: change from initial menopause rating scale score at 6 months
Menopause Rating Scale (MRS) is a questionnaire that assesses the presence and intensity of 11 menopausal symptoms. These are grouped into three subscales: the somatic subscale, the psychological subscale and the urogenital subscale. Each of the 11 items can be rated by the participant from 0 (not present) to 4 (very severe). The scores obtained for each individual item are summed to provide the corresponding total subscale score. The sum of subscales scores provide the total MRS score. Higher scores are indicative of more severe symptoms. Minimum total MRS score is 0 and maximum total MRS score is 44.
次要结局
- Pictorial Bleeding Assessment Score Change(change from initial Pictorial bleeding assessment score at 6 months)
- Menopause Multi-Attribute Score Change on Menopause Multi-Attribute Scale.(change from initial menopause multi-attribute score at 6 months)
- Hemoglobin Value Change(change from initial hemoglobin values at 6 months)
研究者
Ismail Alay
principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital