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
Conditions
Interventions
Product Name: Dexamethasone
Pharmaceutical Form: Capsule
INN or Proposed INN: Dexamethasone Powder Ph Eur
CAS Number: 50-02-2
Concentrat
Sponsors
ACCORD University of Edinburgh
ACCORD, NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Work-up studies (Studies 1&2) To gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding use of oral dexamethasone, in women suffering from objectively verified Heavy Menstrual Bleeding (HMB) Adaptive RCT(Study 3): To identify the optimal dose of oral dexamethasone (Dex) for reduction of Heavy Menstrual Bleeding in women with objectively verified HMB;Secondary Objective: Work-up studies (1&2) - the secondary objectives are: 1. To collect information to enable development of the adaptive RCT design 2. To assess effect of Dexamethasone on co-occurring period pain 3. To explore differences in effect of Dexamethasone in those with MBL of 50-80mls, and for those with MBL >80mls 4. To relate diary assessment of treatment effect against measured MBL. 5. To explore whether Dexamethasone has a carry-over effect. In Workup study 1 only a. To establish whether endometrial biopsy is an indicator of MBL change and of Dexamethasone treatment effect b. To examine changes in blood flow in the womb lining before and after taking Dexamethasone c. To assess predictive value of MRI for endometrial biopsy findings and MBL d. To examine whether an assay can be developed for Dexamethasone concentration in endometrial biopsy Adaptive RCT The secondary objectives are: 1. To gather safety data for Dexamethasone in women with objectively verified;Primary end point(s): Workup Study 1: (Mechanistic) Change in mean Menstrual Blood Loss between baseline and Dexamethasone treatment cycles Workup Study 2: Difference in mean Meanstrual Blood Loss between placebo and Dexamethasone treatment cycles Adaptive trial: Change in mean MBL between baseline and cycles during randomised (Dexamethasone/placebo) treatment;Timepoint(s) of evaluation of this end point: Workup study 1- Individual MBL will be assessed for each patient, by laboratory assay, within one to two weeks of her 2nd treatment cycle with Dexamethasone. End point (mean MBL) will be ev | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Workup studies 1 & 2: 1. Menstrual diary score for volume of menstrual period 2. Satisfaction with treatment 3. Unacceptable side-effects 4. Period pain Mechanistic Workup study 1 only; 5. Assessment of the endometrial response to administration of Dexamethasone in a treated and untreated cycle (histological, molecular, and biochemical assays of tissue) Adaptive trial: 1. Menstrual diary score for volume of menstrual period 2. Satisfaction with treatment 3. Unacceptable side-effects 4. Period pain;Timepoint(s) of evaluation of this end point: Workup studies 1&2 and Adaptive trial:- Individual End points will be evaluated once data are complete for each study participant ie approx 2-3 weeks after last study visit. Unacceptable side effects will be evaluated for each participant at regular intervals during each treatment cycle. | — |
Countries
United Kingdom
Contacts
Public ContactMarianne Laird
Research Governance & QA Office
Outcome results
None listed