NCT01686126

Improving the Treatment for Women With Early Stage Cancer of the Uterus

A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Queensland Centre for Gynaecological Cancer · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for: * young women who still wish to have children and would lose fertility; and * women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe. This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary. Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).

Conditions

• Complex Endometrial Hyperplasia With Atypia
• Grade 1 Endometrial Endometrioid Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Levonorgestrel	Intrauterine device
DRUG	Metformin	oral medication

Timeline

• Start date: 2012-12-01
• Primary completion: 2022-10-03
• Completion: 2026-12-01
• First posted: 2012-09-17
• Last updated: 2024-08-28

Locations

17 sites across 2 countries: Australia, New Zealand