Duphaston® Tablets 5 mg - A Survey on Efficacy and Safety in Patients With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline
研究概览
简要总结
This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients with endometriosis under actual condition of its use and to obtain data for effectively and safely utilizing this drug.
详细描述
In Japan, Duphaston® Tablets have appeared in 1965 for the treatment of endometriosis and been used at some medical institutions. However, after releasing of danazol in the early 1980's and gonadotropin-releasing hormone (GnRH) agonists in the late 1980's, pseudomenopause therapy became mainstream because of its high efficacy. However, pseudopregnancy therapy was recognized again due to adverse reactions associated with pseudomenopause therapy. After 2000, low-dose estrogen/progestin (LEP) combination drugs (as LEP products, ethinylestradiol/norethisterone combination drug and ethinylestradiol/drospirenone combination drug) and dienogest have been utilized as drugs that are safer and can be administered for a long time. In recent years, Duphaston® Tablets are increasing recognized again from the viewpoints of its efficacy and safety because the drug has no effect to inhibit ovulation or effect on basal body temperature, a diagnosis of ovulation and other conditions may be made by following up basal body temperature, and pregnancy may be achieved even during treatment with Duphaston. As previously mentioned, Duphaston® Tablets are an old drug, and there are only few clinical data from Japanese patients; thus, its latest clinical efficacy and safety data are being demanded again mainly by obstetrician-gynecologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 to < 50 years
- •Subjects with a chocolate cyst of the ovary measuring 3 cm in diameter on transvaginal ultrasonography at patient enrollment
- •Subjects with a menstrual cycle of 25 to 38 days who ovulate and are confirmed to have normal menstruation at patient enrollment
排除标准
- •Subjects who used GnRH agonists within 6 months before patient enrollment
- •Subjects who utilized hormone preparations containing corpus luteum hormone or estrogen as an active ingredient, low-dose contraceptive pills, middle-dose contraceptive pills, testosterone derivatives, or herbal products indicated for endometriosis within 3 months before patient enrollment
- •Subjects who received surgical treatment for endometriosis such as transvaginal alcohol fixation, laparotomy or laparoscopic surgery within 2 months before patient enrollment
- •Subjects who are pregnant or may possibly be pregnant at patient enrollment
- •Subjects who are in breast feeding at patient enrollment
- •Subjects who are determined by the investigator/subinvestigator to be not suitable for the subjects of the survey because of other reasons
- •Subjects with liver disorder or liver disease
- •Subjects with known hypersensitivity to the active substance or to any of the excipients
- •Subjects with known or suspected progestogen dependent neoplasms (e.g. meningioma)
- •Subjects with undiagnosed vaginal bleeding
- •Subjects with a past or current history of heart or kidney disease
- •Subjects with porphyria
- •Subjects with depression
- •Subjects with abnormal liver function values caused by acute or chronic liver disease
- •Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
研究组 & 干预措施
Dydrogesterone
Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.
干预措施: Dydrogesterone (Drug)
结局指标
主要结局
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline
时间窗: Before treatment initiation (baseline), 3 months, and 5 months.
The % change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated. For the mean value of the % changes shown here, the mean value of the % changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the % change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the % change in 40 cases with the volume value at this time. The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the % change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5. For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline
时间窗: Before treatment initiation (baseline), 3 months, and 5 months.
The absolute change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated. For the mean value of the absolute changes shown here, the mean value of the absolute changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the absolute change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the absolute change in 40 cases with the volume value at this time. The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the absolute change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5. For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume)
时间窗: Before treatment initiation (baseline), 3 months, and 5 months.
In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: \[(D1 + D2) × 1/2\]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner.
Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume)
时间窗: Before treatment initiation (baseline), 3 months, and 5 months.
In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: \[(D1 + D2) × 1/2\]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner. The change rate within ±15% from the total volume measured before treatment was defined as "unchanged," and the rate out of this range was defined as "decreased" or "increased."
次要结局
- Change in Serum CA125(Baseline, and 5 months.)
- Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Change Rate From Baseline (%)(Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.)
- Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score)(Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.)
- Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea(Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.)
- Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Difference From Baseline(Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.)
- Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score), Difference From Baseline(Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.)
- Change in Serum CA125, Change Rate From Baseline (%)(Baseline, and 5 months.)
- Change in Serum CA125, Difference From Baseline(Baseline, and 5 months.)