EndoPHI
Research type
Research Study
Full title
A Proof-of-Concept Study to Determine if Oral Prolyl Hydroxylase Inhibitors (e.g., Roxedustat) are active in the endometrium (EndoPHI).
IRAS ID
351065
Contact name
Jacqueline Maybin
Contact email
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Heavy periods or heavy menstrual bleeding affects a quarter of women of reproductive age in the UK. Heavy periods is also a huge financial burden for women, their families, society and healthcare. The side effects of current hormonal treatments mean up to 60% of women seeking treatment resort to risky, fertility ending surgery. There is a clear unmet need for fertility preserving, non-hormonal medical treatment for heavy periods, yet this common and debilitating condition remains under-researched.
Previous studies of the lining of the womb have shown low oxygen levels occur in the womb lining during each menstrual cycle, at the time of a period. If this low oxygen level does not occur during a period, it's repair is delayed and this can result in heavy menstrual bleeding. The study aims to better understand the effects that the oral medication Roxedustat has on the lining of the womb (endometrium).
The study aims to determine whether the oral medication Roxedustat increases levels of the protein HIF-1a in the lining of the womb. The results from the study may be used to inform future studies of new treatments for heavy menstrual bleeding.
Participants in the study will provide a biopsy of the lining of the womb to determine whether prolyl hydroxylase inhibitors (Roxedustat) is active in the lining of the womb after they are taken orally. Participants will not be given these medications as part of the study, but will be taking as part of their clinical care for renal anaemia. A peripheral blood sample will also be obtained to confirm participants stage of menstrual cycle.
In future, a non-hormonal treatment option for heavy periods would allow treatment options to be more specific and effective, whilst maintaining fertility in women of reproductive age. This would improve patient experiences and health outcomes, by ensuring acceptable and effective targeted treatments of heavy periods.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0128
Date of REC Opinion
13 Aug 2025
REC opinion
Further Information Favourable Opinion