Dexamethasone for treatment of heavy menstrual bleeding

Phase 1

• Conditions: Endometrial glucocorticoid deficiency in Heavy Menstrual Bleeding; MedDRA version: 14.1 Level: PT Classification code 10027313 Term: Menorrhagia System Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-003405-98-GB
• Lead Sponsor: ACCORD University of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified