Heavy Menstrual BleedingPhase 2dexFEMNCT01769820
Dexamethasone for Excessive Menstruation
A Phase 2 study testing Dexamethasone in people with Heavy Menstrual Bleeding, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study builds on previous research which has provided compelling evidence that deficient activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to 18 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Complaint of HMB, including women with fibroids
- Pre-menopausal
- Age 18 years and over
- Describing menstrual cycles every 21- 42 days
- Provide written informed consent prior to any study related procedures
- If of childbearing potential either agree to practice a non-hormonal method of contraception for duration of study or have a partner with a vasectomy
- Workup (Study 1 or 2)- MBL for single screening period is >= 50mL
- Adaptive Trial (Study 3)- average MBL for two screening menstrual collections is >= 50mL
Who cannot join
- Currently breast-feeding
- History or current uterus, cervix, ovarian or breast cancer
- Known severe coagulation disorder
- Glucocorticoid treatment or sex steroid administration by any route in previous 1 month
- Taking prohibited medication -
- Thyroid, renal or liver dysfunction
Show all 15Show fewer
- Diabetes mellitus
- Treated moderate/severe hypertension
- Psychotic depressive illness
- Rare hereditary galactose intolerance, lactase deficiency or glucose galactose malabsorption (due to lactose content of trial medication)
- Has a problem with alcohol or drug abuse
- Has a mental condition rendering her unable to understand the nature and scope of the study
- Participation in treatment phase in any earlier DexFEM study (1 or 2)
- 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
- workup study 1, only, an additional exclusion criterion of any contra-indication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developmental Clinical Studies - Reversing Endometrial Glucocorticoid Deficiency in Heavy Menstrual Bleeding
This study builds on previous research which has provided compelling evidence that deficient activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding. This study aims to demonstrate that a glucocorticoid (dexamethasone), already in common use for other conditions, (eg to treat medical conditions such as asthma and rheumatoid arthritis in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as a result reduce menstrual blood loss.
The study is in two stages, a 12 month workup stage and a 3 year, response adaptive, dose-finding randomised controlled trial. The first stage involves two workup clinical studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding use of oral dexamethasone. They will also provide methodological data for a series of simulation studies to determine a robust adaptive trial design specification.
Read more
Workup study 1: is unblinded, six patients will be given Dexamethasone (0.75mg twice daily) for 5 days during two consecutive menstrual cycles and will have an endometrial biopsy and MRI on two occasions (in a nontreated cycle, and the second of the cycles treated with Dexamethasone). Workup study 2; is a doubleblind crossover trial of 14 women -2 treatment blocks of two cycles each, with either placebo or Dexamethasone (0.75mg twice daily), randomised to order of treatments blocks - placebo then Dexamethasone, or vice-versa.
Adaptive trial: 54 month double-blind, placebo controlled trial of 108 women to evaluate the effect of Dexamethasone across a range of doses with the aim of identifying the optimal dose to be studied in a subsequent Phase III trial.
Participants will be randomised to receive one of 6 active doses or placebo over 3 menstrual cycles.
All studies will involve asking participants to complete menstrual diaries and to carry out menstrual blood loss collections to objectively measure blood loss.
The investigators' proposed approach is novel use of synthetic glucocorticoid to "rescue" luteal phase deficiency of cortisol, and thus improve endometrial vasculature and hence vasoconstriction when menses commences, and thus reduce menstrual bleeding.
Read the detailed description
Background Menstrual bleeding complaints affect quality of life and comprise a substantial societal burden, including major impact on health care use and costs. Current medical therapy for heavy menstrual bleeding (HMB) is often ineffective and/or associated with unacceptable side effects. There is unmet clinical need for targeted, effective, medical treatment strategies for HMB. The investigators' findings from research into mechanisms in HMB has led to the conclusion that women with HMB have enhanced endometrial inactivation of cortisol by 11βHSD2 resulting in local endometrial glucocorticoid deficiency, changes in prostaglandin (PG) production, and altered structure and deficient vasoconstriction of the endometrial vasculature. The investigators therefore anticipate that luteal phase "rescue" of endometrial glucocorticoid deficiency will provide a novel approach to therapy for women with HMB. The synthetic glucocorticoid dexamethasone (Dex) is a potent cortisol surrogate and glucocorticoid receptor (GR) agonist that resists 11βHSD2 inactivation. In a non-human primate study the investigators have observed a striking reduction in menstrual blood loss after Dexamethasone administration.
Objectives The investigators aim to show proof-of-concept that Dexamethasone administration in women with HMB will improve the capacity of endometrial vasculature for efficient vasoconstriction when menses commences, and hence reduce menstrual bleeding. The investigators' proposal is a novel use of an existing, well-characterised medical treatment (Dex).
Methods The Investigators propose a parallel group randomised controlled trial in women with HMB comparing Dexamethasone (over a range of potential doses) to placebo treatment. The trial design will be response-adaptive, whereby randomisation probabilities change across time to ensure that maximum information is obtained in the critical region of the underlying dose-response curve (that containing the 'optimum' dose). This has the added advantage that relatively more and more women are randomised to the doses emerging as most effective. Such a design is the most parsimonious way to enable both robust demonstration of the therapeutic effect of Dexamethasone on HMB, and reliable identification of the optimal dose to take forward for future further study in a Phase III trial.
Work Up Stage Adaptive designs such as this require a work up stage to enable the simulation modelling necessary to determine a robust final design specification with adequate power (here, the expected number of patients required lies in the range 100-108). In addition this work up stage will allow two clinical studies to be executed. Data collected in these will inform the modelling and simulation, but will also enhance mechanistic and pharmacodynamic understanding of observed Dexamethasone effect, and will be an invaluable preliminary check of safety of this 'first-in-HMB' use of oral Dexamethasone. These studies will involve treating in total 20 women with HMB with two cycles of Dexamethasone (1.5mg daily).
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Dexamethasone, placebo
- Keywords
- Heavy menstrual bleeding (HMB), Dexamethasone, glucocorticoid
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called D07AB19
studies 1\&2:0.75mg twice daily for 5 days, starting on day LH (Luteinising Hormone)+8 of menstrual cycle; Study 3 (adaptive) 0.2,0.4,0.5,0.75,0.8,0.9mg twice daily as above
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Study 1, and study2(2 arms); Dexamethasone 1.5mg daily Study 3 (adaptive -7 arms): Dexamethasone of 0.4, 0.8, 1.0, 1.2, 1.5, and 1.8 mg total dose per day Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change or difference in mean laboratory measured menstrual blood loss(MBL)
study1:Change in mean MBL between baseline and Dexamethasone treatment cycles. Study2:Difference in mean MBL between placebo and Dexamethasone treatment cycles.
Study3 (adaptive):Change in mean MBL between baseline and cycles during randomised (Dexamethasone/placebo) treatment
Measured: 3-4months
Secondary outcomes (5)
Menstrual diary score for volume of menstrual period
menstrual blood loss estimated from patient's daily record of menstrual products used
Measured: 3-4months
Satisfaction with treatment by means of a participant completed treatment review questionnaire
Participants will be asked to complete a treatment review questionnaire at the end of their study participation to elicit subjective assessment of the effect of the study treatment.
Measured: 3-4months
Number of participants with adverse events as a measure of safety and tolerability
Participants will be asked about the occurrence of adverse events at each study visit and at each contact with the research team.Adverse events will be recorded from time of consent to 30 days after last treatment dose.
Measured: 3-4months
Examine effect of treatment on Period pain via participant self-report questionnaire
Participants will be asked to assess levels of period pain in the menstrual diaries and in the pre and post treatment questionnaires.
Measured: 3-4months
Mechanistic examination of response to Dexamethasone
study 1 only:mechanistic variables comparing an un-treated and a treated cycle via MRI scan and endometrial biopsy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion29 Mar 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Principal investigator, Hilary Critchley, University of Edinburgh
- Investigators
- Hilary Critchley, MBChB MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769820
- Sponsor's protocol ID
- dexfemv2
- Acronym
- dexFEM
- Status last verified
- Oct 2018
- First submitted
- 19 Dec 2012
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Critchley HO, Maybin JA. Molecular and cellular causes of abnormal uterine bleeding of endometrial origin. Semin Reprod Med. 2011 Sep;29(5):400-9. doi: 10.1055/s-0031-1287664. Epub 2011 Nov 7.
PubMed 22065326Rae M, Mohamad A, Price D, Hadoke PW, Walker BR, Mason JI, Hillier SG, Critchley HO. Cortisol inactivation by 11beta-hydroxysteroid dehydrogenase-2 may enhance endometrial angiogenesis via reduced thrombospondin-1 in heavy menstruation. J Clin Endocrinol Metab. 2009 Apr;94(4):1443-50. doi: 10.1210/jc.2008-1879. Epub 2009 Jan 21.
PubMed 19158196Warner P, Whitaker LHR, Parker RA, Weir CJ, Douglas A, Hansen CH, Madhra M, Hillier SG, Saunders PTK, Iredale JP, Semple S, Slayden OD, Walker BR, Critchley HOD. Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM). EBioMedicine. 2021 Jul;69:103434. doi: 10.1016/j.ebiom.2021.103434. Epub 2021 Jul 2.
PubMed 34218053Warner P, Weir CJ, Hansen CH, Douglas A, Madhra M, Hillier SG, Saunders PT, Iredale JP, Semple S, Walker BR, Critchley HO. Low-dose dexamethasone as a treatment for women with heavy menstrual bleeding: protocol for response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM). BMJ Open. 2015 Jan 14;5(1):e006837. doi: 10.1136/bmjopen-2014-006837.
PubMed 25588784
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Clinical Studies - Reversing Endometrial Glucocorticoid Deficiency in Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT01769820
- Acronym / sponsor ID
- dexFEM / dexfemv2
- Conditions
- Heavy Menstrual Bleeding
- Keywords
- Heavy menstrual bleeding (HMB), Dexamethasone, glucocorticoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Jan 2013 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study builds on previous research which has provided compelling evidence that deficient activity of glucocorticoids in the endometrium is a cause of increased menstrual bleeding. This study aims to demonstrate that a glucocorticoid (dexamethasone), already in common use for other conditions, (eg to treat medical conditions such as asthma and rheumatoid arthritis in early pregnancy), will reverse the endometrial glucocorticoid deficiency and as a result reduce menstrual blood loss.
The study is in two stages, a 12 month workup stage and a 3 year, response adaptive, dose-finding randomised controlled trial. The first stage involves two workup clinical studies to gather preliminary safety and efficacy data from first-in-Heavy Menstrual Bleeding use of oral dexamethasone. They will also provide methodological data for a series of simulation studies to determine a robust adaptive trial design specification.
Workup study 1: is unblinded, six patients will be given Dexamethasone (0.75mg twice daily) for 5 days during two consecutive menstrual cycles and will have an endometrial biopsy and MRI on two occasions (in a nontreated cycle, and the second of the cycles treated with Dexamethasone). Workup study 2; is a doubleblind crossover trial of 14 women -2 treatment blocks of two cycles each, with either placebo or Dexamethasone (0.75mg twice daily), randomised to order of treatments blocks - placebo then Dexamethasone, or vice-versa.
Adaptive trial: 54 month double-blind, placebo controlled trial of 108 women to evaluate the effect of Dexamethasone across a range of doses with the aim of identifying the optimal dose to be studied in a subsequent Phase III trial.
Participants will be randomised to receive one of 6 active doses or placebo over 3 menstrual cycles.
All studies will involve asking participants to complete menstrual diaries and to carry out menstrual blood loss collections to objectively measure blood loss.
The investigators' proposed approach is novel use of synthetic glucocorticoid to "rescue" luteal phase deficiency of cortisol, and thus improve endometrial vasculature and hence vasoconstriction when menses commences, and thus reduce menstrual bleeding.
Detailed description
Background Menstrual bleeding complaints affect quality of life and comprise a substantial societal burden, including major impact on health care use and costs. Current medical therapy for heavy menstrual bleeding (HMB) is often ineffective and/or associated with unacceptable side effects. There is unmet clinical need for targeted, effective, medical treatment strategies for HMB. The investigators' findings from research into mechanisms in HMB has led to the conclusion that women with HMB have enhanced endometrial inactivation of cortisol by 11βHSD2 resulting in local endometrial glucocorticoid deficiency, changes in prostaglandin (PG) production, and altered structure and deficient vasoconstriction of the endometrial vasculature. The investigators therefore anticipate that luteal phase "rescue" of endometrial glucocorticoid deficiency will provide a novel approach to therapy for women with HMB. The synthetic glucocorticoid dexamethasone (Dex) is a potent cortisol surrogate and glucocorticoid receptor (GR) agonist that resists 11βHSD2 inactivation. In a non-human primate study the investigators have observed a striking reduction in menstrual blood loss after Dexamethasone administration.
Objectives The investigators aim to show proof-of-concept that Dexamethasone administration in women with HMB will improve the capacity of endometrial vasculature for efficient vasoconstriction when menses commences, and hence reduce menstrual bleeding. The investigators' proposal is a novel use of an existing, well-characterised medical treatment (Dex).
Methods The Investigators propose a parallel group randomised controlled trial in women with HMB comparing Dexamethasone (over a range of potential doses) to placebo treatment. The trial design will be response-adaptive, whereby randomisation probabilities change across time to ensure that maximum information is obtained in the critical region of the underlying dose-response curve (that containing the 'optimum' dose). This has the added advantage that relatively more and more women are randomised to the doses emerging as most effective. Such a design is the most parsimonious way to enable both robust demonstration of the therapeutic effect of Dexamethasone on HMB, and reliable identification of the optimal dose to take forward for future further study in a Phase III trial.
Work Up Stage Adaptive designs such as this require a work up stage to enable the simulation modelling necessary to determine a robust final design specification with adequate power (here, the expected number of patients required lies in the range 100-108). In addition this work up stage will allow two clinical studies to be executed. Data collected in these will inform the modelling and simulation, but will also enhance mechanistic and pharmacodynamic understanding of observed Dexamethasone effect, and will be an invaluable preliminary check of safety of this 'first-in-HMB' use of oral Dexamethasone. These studies will involve treating in total 20 women with HMB with two cycles of Dexamethasone (1.5mg daily).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneStudy 1, and study2(2 arms); Dexamethasone 1.5mg daily Study 3 (adaptive -7 arms): Dexamethasone of 0.4, 0.8, 1.0, 1.2, 1.5, and 1.8 mg total dose per day |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Complaint of HMB, including women with fibroids
- Pre-menopausal
- Age 18 years and over
- Describing menstrual cycles every 21- 42 days
- Provide written informed consent prior to any study related procedures
Key exclusion criteria (15 listed)
- Currently breast-feeding
- History or current uterus, cervix, ovarian or breast cancer
- Known severe coagulation disorder
- Glucocorticoid treatment or sex steroid administration by any route in previous 1 month
- Taking prohibited medication -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: D07AB19studies 1\&2:0.75mg twice daily for 5 days, starting on day LH (Luteinising Hormone)+8 of menstrual cycle; Study 3 (adaptive) 0.2,0.4,0.5,0.75,0.8,0.9mg twice daily as above | Drug | Dexamethasone |
| placebo | Drug | Placebo |
Primary outcome
Change or difference in mean laboratory measured menstrual blood loss(MBL)
Time frame: 3-4months
study1:Change in mean MBL between baseline and Dexamethasone treatment cycles. Study2:Difference in mean MBL between placebo and Dexamethasone treatment cycles. Study3 (adaptive):Change in mean MBL between baseline and cycles during randomised (Dexamethasone/placebo) treatment
5 secondary outcomes
Menstrual diary score for volume of menstrual period
Time frame: 3-4months
Satisfaction with treatment by means of a participant completed treatment review questionnaire
Time frame: 3-4months
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 3-4months
Examine effect of treatment on Period pain via participant self-report questionnaire
Time frame: 3-4months
Mechanistic examination of response to Dexamethasone
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 22065326Critchley HO, Maybin JA. Molecular and cellular causes of abnormal uterine bleeding of endometrial origin. Semin Reprod Med. 2011 Sep;29(5):400-9. doi: 10.1055/s-0031-1287664. Epub 2011 Nov 7.
- Background: PubMed 19158196Rae M, Mohamad A, Price D, Hadoke PW, Walker BR, Mason JI, Hillier SG, Critchley HO. Cortisol inactivation by 11beta-hydroxysteroid dehydrogenase-2 may enhance endometrial angiogenesis via reduced thrombospondin-1 in heavy menstruation. J Clin Endocrinol Metab. 2009 Apr;94(4):1443-50. doi: 10.1210/jc.2008-1879. Epub 2009 Jan 21.
- Derived from this study: PubMed 34218053Warner P, Whitaker LHR, Parker RA, Weir CJ, Douglas A, Hansen CH, Madhra M, Hillier SG, Saunders PTK, Iredale JP, Semple S, Slayden OD, Walker BR, Critchley HOD. Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM). EBioMedicine. 2021 Jul;69:103434. doi: 10.1016/j.ebiom.2021.103434. Epub 2021 Jul 2.
- Derived from this study: PubMed 25588784Warner P, Weir CJ, Hansen CH, Douglas A, Madhra M, Hillier SG, Saunders PT, Iredale JP, Semple S, Walker BR, Critchley HO. Low-dose dexamethasone as a treatment for women with heavy menstrual bleeding: protocol for response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM). BMJ Open. 2015 Jan 14;5(1):e006837. doi: 10.1136/bmjopen-2014-006837.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary Critchley, MBChB MD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Heavy Menstrual Bleeding, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change or difference in mean laboratory measured menstrual blood loss(MBL) (time frame: 3-4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769820, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.