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临床试验/NCT02103764
NCT02103764Unknown3 期

The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
160
试验地点
1
主要终点
The change in endometrial histology

研究概览

简要总结

The objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects:

  1. Endometrial histopathology changes
  2. Menstrual cycle control.

详细描述

Anovulatory dysfunctional uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding especially in postmenarcheal adolescent, perimenopausal women, patient with polycystic ovary syndrome (PCOS) and in obese women. Aims of treatment in women with anovulatory DUB are to restore the natural control mechanism of endometrium (introduce normal synchronous growth, development, shedding of a structural stable endometrium) and to prevent endometrial hyperplasia. The two main treatment options are estrogen-progestin therapy and progestin therapy. Women who are sexually active and not immediately prepared to pursue pregnancy are best manage by estrogen-progestin treatment especially combined oral contraceptive pills (COCs) but in perimenopausal women, obese women or women who can't tolerate COCs or have contraindications in using COCs, cyclic progestin will be the treatment of choice. Common used progestin in anovulatory DUB is medroxyprogesterone acetate (MPA) 5-10 mg/day for 10-14 days each month. This progestin has strong progestogenic effect but has some undesirable effect such as glucocorticoid effect, mineralocorticoid effect and androgenic effect. Long term using this progestin especially in obese women or perimenopausal women who have risk for diabetes mellitus and dyslipidemia may be negative effect to glucose and lipid metabolism. DSG is the third generation progestin with no glucocorticoid, mineralocorticoid effect and low androgenic effect may be the better choice of treatment but the data of DSG in treatment of anovulatory DUB us scanty. So this study will evaluate the effect of cyclic DSG in endometrial histology changing and lipid, glucose metabolism in patient with anovulatory DUB.

Comparison : Women with anovulatory DUB are randomized into two groups, receiving a course of either cyclic DSG or cyclic MPA. The main outcome measured is to compare the effect of both interventions on endometrial histology changing.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal women with anovular DUB (proved by endometrial histology)
  • Age > 18 yr.

排除标准

  • Any uterine pathology that might cause abnormal uterine bleeding
  • Contraindication to progestin treatment (such as breast cancer)
  • Severe drug allergy towards a progestogen
  • Intake of any hormonal treatment in the previous 3 months

研究组 & 干预措施

Desogestrel

Experimental

Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month

干预措施: Desogestrel (Drug)

Medroxyprogesterone acetate

Active Comparator

Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month

干预措施: Medroxyprogesterone acetate (Drug)

结局指标

主要结局

The change in endometrial histology

时间窗: Baseline, Day 8 or 9 or 10 of treatment period in first month

The participants are evaluated for changing of endometrial histology at day 8 or 9 or 10 of treatment period.

次要结局

  • The occurrence of withdrawal bleeding(6 months)
  • Adverse events(At day 8 or 9 or 10 of the first cycle and 3, 6 month)
  • Effect of cyclic DSG on lipid metabolism compared with cyclic MPA(6 months)
  • Effect of cyclic DSG on glucose metabolism compared with cyclic MPA(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manee Rattanachaiyanont

Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Mahidol University

研究点 (1)

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