Progesterone therapy for endometrial cancer prevention in obese wome

Phase 2

Completed

Conditions: Topic: Cancer, Metabolic and endocrine disorders
Subtopic: Gynaecological Cancer, Metabolic and Endocrine (all Subtopics)
Disease: Uterus/Endometrium, Metabolic & Endocrine (not diabetes)
Cancer

Registration Number: ISRCTN40940943

Lead Sponsor: ational Institute for Health Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 40

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Ki-67

Secondary Outcome Measures

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