Progesterone therapy for endometrial cancer prevention in obese women
| ISRCTN | ISRCTN40940943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40940943 |
| Protocol serial number | 18843 |
| Sponsor | National Institute for Health Research |
| Funder | National Institute for Health Research |
- Submission date
- 22/04/2015
- Registration date
- 23/04/2015
- Last edited
- 29/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
St Mary's Hospital Manchester
5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Prevention, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | PROgesterone Therapy for Endometrial Cancer prevention in obese women: an interventional trial |
| Study acronym | PROTEC1 |
| Study objectives | 1. To evaluate the efficacy of the Mirena IUS for endometrial protection; including histological impact and the expression of biomarkers of proliferation, apoptosis and other pathways associated with increased risk of endometrial cancer 2. To determine the feasibility, safety and acceptability of using the Mirena IUS for endometrial protection 3. To determine the effect of Mirena IUS insertion on systemic endocrine function and mental and physical wellbeing |
| Ethics approval(s) | 15/EE/0063 |
| Health condition(s) or problem(s) studied | Topic: Cancer, Metabolic and endocrine disorders; Subtopic: Gynaecological Cancer, Metabolic and Endocrine (all Subtopics); Disease: Uterus/Endometrium, Metabolic & Endocrine (not diabetes) |
| Intervention | 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 biopsies of the lining of the womb taken before and after insertion of a Mirena IUS. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Ki-67 |
| Key secondary outcome measure(s) |
1. Histopathology |
| Completion date | 01/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 01/08/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/12/2015: The recruitment end date has been extended to 01/08/2016 from 01/11/2015.
