Mirena IUS for Womb Cancer Protection

PROgesterone Therapy for Endometrial Cancer prevention in obese women (PROTEC) - PROTEC1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005610-37-GB

Enrollment

Registered

2015-03-30

Start date

2015-05-07

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Proliferation of the endometrium.

Interventions

Trade Name: Mirena Intra Uterine System Product Name: Mirena 20micrograms/24hours intrauterine delivery system Pharmaceutical Form: Intrauterine delivery system

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Women seen in the Sleep Apnoea Clinic at Salford Royal Hospital 2 BMI >40 3 Informed consent 4 Aged 18 or over 5 Normal up to date smear 6 Normal endometrial sample at screening 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1) Previous hysterectomy 2) LNG-IUS or IUD in situ or in previous 6 months 3) Pregnant or breast feeding 4) Previous endometrial ablation 5) Breast cancer 6) Congenital/acquired uterine anomaly 7) Pelvic inflammatory disease, current STI or genital actinomycosis 8) Immunodeficiency 9) Progestin IUS contraindicated (coagulopathy, liver disease, migraine, raised blood pressure, arterial disease)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the Mirena coil is effective at interrupting pathways in the womb associated with increased risk of developing cancer.; Primary end point(s): 1) Ki 67 expression in the endometrium (a marker of proliferation). ; Secondary Objective: 1) To assess if the Mirena IUS is acceptable to women as a preventative treatment for endometrial cancer. 2) To assess the effects the Mirena IUS on physical and mental wellbeing. 3) To see what effects (if any) the Mirena IUS has on hormone levels in the blood in obese women ;Timepoint(s) of evaluation of this end point: Serial endometrial biopsies and fasting study bloods will be taken at the screening appointment, at Mirena insertion and 6-9 months following Mirena insertion. The questionnaire will be completed at the screening appointment and at the 9-12 month follow-up appointment.	—

Measure

Time frame

Main Objective: To determine whether the Mirena coil is effective at interrupting pathways in the womb associated with increased risk of developing cancer.; Primary end point(s): 1) Ki 67 expression in the endometrium (a marker of proliferation). ; Secondary Objective: 1) To assess if the Mirena IUS is acceptable to women as a preventative treatment for endometrial cancer. 2) To assess the effects the Mirena IUS on physical and mental wellbeing. 3) To see what effects (if any) the Mirena IUS has on hormone levels in the blood in obese women ;Timepoint(s) of evaluation of this end point: Serial endometrial biopsies and fasting study bloods will be taken at the screening appointment, at Mirena insertion and 6-9 months following Mirena insertion. The questionnaire will be completed at the screening appointment and at the 9-12 month follow-up appointment.

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Secondary

Measure	Time frame
Secondary end point(s): 3) Endocrine markers including but not limited to: a. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels b. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP c. Leptin, adiponectin 4) Changes in menstrual function, physical and mental wellbeing ;Timepoint(s) of evaluation of this end point: We will take a detailed medical and gynaecological history, including a history of menstrual abnormalities, hormonal and contraceptive use and baseline observations at all three appointments (screening, Mirena insertion and 6-9 month follow up).	—

Measure

Time frame

Secondary end point(s): 3) Endocrine markers including but not limited to: a. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels b. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP c. Leptin, adiponectin 4) Changes in menstrual function, physical and mental wellbeing ;Timepoint(s) of evaluation of this end point: We will take a detailed medical and gynaecological history, including a history of menstrual abnormalities, hormonal and contraceptive use and baseline observations at all three appointments (screening, Mirena insertion and 6-9 month follow up).

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Countries

United Kingdom

Contacts

Public ContactDr Emma Crosbie

University of Manchester

emma.crosbie@manchester.ac.uk0161 701 6912

Outcome results

None listed

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