Progesterone therapy for endometrial cancer prevention in obese women

PROgesterone Therapy for Endometrial Cancer prevention in obese women: an interventional trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40940943

Enrollment

Registered

2015-04-23

Start date

2015-05-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Topic: Cancer, Metabolic and endocrine disorders

Interventions

Women with a BMI >40 who are seen by the Sleep Apnoea Service at Salford Royal Hospital will be asked if they wish to participate in the trial. They will complete a questionnaire, blood samples and bi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women seen in sleep apnoea clinic at Salford Royal Hospital 2. BMI>40 3. Informed consent 4. Aged 18 years or over 5. Not actively trying to lose weight 6. Normal up to date smear 7. Normal endometrial sampling at screening

Exclusion criteria

Exclusion criteria: 1. Previous hysterectomy 2. LNG-IUS or IUD in situ or in previous 6 months 3. Pregnant or breast feeding, previous endometrial ablation 4. Breast cancer 5. Congenital/acquired uterine anomaly 6. Pelvic inflammatory disease or genital actinomycosis 7. Immunodeficiency 8. Mirena IUS contraindicated 9. Taking systemic progestagens 10. Patient actively trying to lose weight (awaiting bariatric surgery)

Design outcomes

Secondary

Measure	Time frame
1. Histopathology 2. Phospho-H3 3. Cleaved Caspase 3, cleaved PARP 4. MAPK signalling molecules and their phosphorylated isoforms 5. P13K-AKT-mTOR signalling molecules and their phosphorylated isoforms 6. PTEN and AMPK, P53 7. Strathmin, cyclin A, c-myc 8. Oestrogen, progesterone, LH, FSH, insulin, adiponectin and leptin receptors 9. IGF-1IR, IGF2, EIG121, RALDH2, SFRP-1, SFRP-4, Survivin 10. Endocrine markers including but not limited to: 11. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels 12. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP 13. Leptin, adiponectin 14. Changes in menstrual function, physical and mental wellbeing	—

Measure

Time frame

1. Histopathology 2. Phospho-H3 3. Cleaved Caspase 3, cleaved PARP 4. MAPK signalling molecules and their phosphorylated isoforms 5. P13K-AKT-mTOR signalling molecules and their phosphorylated isoforms 6. PTEN and AMPK, P53 7. Strathmin, cyclin A, c-myc 8. Oestrogen, progesterone, LH, FSH, insulin, adiponectin and leptin receptors 9. IGF-1IR, IGF2, EIG121, RALDH2, SFRP-1, SFRP-4, Survivin 10. Endocrine markers including but not limited to: 11. Fasting serum glucose & insulin, HbA1c, IGFBP-1 and C-peptide levels 12. SHBG, oestrogen, progesterone, free androgen index, FSH, LH, testosterone, CRP 13. Leptin, adiponectin 14. Changes in menstrual function, physical and mental wellbeing

—

Primary

Measure	Time frame
1. Ki-67	—

Countries

United Kingdom

Outcome results

None listed

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