Developmental Clinical Studies - Reversing endometrial glucocorticoid deficiency in heavy menstrual bleeding - Dexamethasone for excessive menstrual bleeding

ACCORD University of Edinburgh0 个研究点目标入组 128 人开始时间: 2012年10月25日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Women will be invited to participate if they fulfil the following criteria: 1. with complaint of HMB, including women with fibroids 2. pre-menopausal 3. age 18 years and over 4. describing menstrual cycles every 21- 42 days 5. If of childbearing potential either agrees to practice a non-hormonal method of contraception for duration of study or has a partner with a vasectomy 6. Workup studies (1&2) – MBL for a single screening period is >= 50mL RCT (study 3) – average MBL for two screening menstrual collections is >= 50mL
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Main exclusion criteria are: 1. A history or current uterus, cervix, ovarian or breast reproductive tract cancer 2. A known severe coagulation disorder 3. Glucocorticoid treatment or sex steroid administration by any route in previous 1 month 4. Thyroid, renal or liver dysfunction 5. Diabetes mellitus 6. Treated moderate/severe hypertension 7. Women with rare hereditary galactose intolerance, lactase deficiency or glucose galactose malabsorption (due to Lactose content of trial medication). 8. A problem with alcohol or drug abuse 9. A mental condition rendering the participant unable to understand the nature and scope of the study 10.Psychotic depressive illness 11.The subject is currently enrolled in an investigational drug or device study or participated in such a study within the previous 30 days and is still in exclusion period 12. Participation in treatment phase in any earlier DexFEM study (1 or 2). 13. The subject has been taking prohibited medication as detailed in protocol section 6.7.3 14. Currently breastfeeding 15. For workup study 1 there will be an additional exclusion criterion of any contra-indication to MRI (eg claustrophobic feelings.

发起方

ACCORD University of Edinburgh