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MIrena coil to Reduce Endometrial Neoplastic Abnormalities

Predicting response to progestins for the treatment of endometrial hyperplasia and endometrioid adenocarcinoma of the endometrium

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31662931
Enrollment
150
Registered
2014-06-12
Start date
2014-06-16
Completion date
Unknown
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial hyperplasia and endometrioid adenocarcinoma of the endometrium Cancer

Interventions

Current intervention as of 11/04/2023: A detailed gynaecological history, including parity, menstrual abnormalities, hormonal and contraceptive use will be taken when recruited. Weight

Sponsors

Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Age 18 or more 2. Attending the gynaecological outpatient clinic at St Mary?s Hospital 3. Biopsy-proven well differentiated endometrioid adenocarcinoma of the endometrium (EC) with no myometrial invasion and/or endometrial hyperplasia (EH) 4. Clinical decision to treat EH or EC with progestins 5. Written, informed consent to take part in the study; Target Gender: Female

Exclusion criteria

Exclusion criteria: 1. Non endometrioid or mixed histology or concerning histological features 2. Myometrial invasion on imaging 3. Progestin therapy contraindicated 4. Unable to sample endometrium pre/post progestin therapy

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 11/04/2023: Ki-67 and progesterone receptor status; Timepoint(s): At approximately 3-monthly intervals (for up to a total of 60 months) _____ Previous primary outcome measure: Ki-67 and progesterone receptor status; Timepoint(s): At approximately 3 monthly intervals (for up to a total of 12 months)

Secondary

MeasureTime frame
Not provided at time of registration

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026