Mirena IUS for Womb Cancer Protectio

Phase 1

• Conditions: Proliferation of the endometrium.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005610-37-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1Women seen in the Sleep Apnoea Clinic at Salford Royal Hospital
2BMI >40
3Informed consent
4Aged 18 or over
5Normal up to date smear
6Normal 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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified