A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments:

1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle,

2. MPA 10 mg continuously for 6 months,

3. Mirena (Levonorgestrel) impregnated IUD for 6 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of North Norway
• Collaborators: Helse Nord; Norwegian Cancer Society
• Treatments: Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate; Progestins

Criteria

Inclusion Criteria:

• Histologically confirmed endometrial hyperplasia,

• D-score > 0,

• Age 30-70 years,

• No contra-indications against progestin hormones,

• Written consent,

• Patients who have been treated with transcervical resection need a histologically confirmed diagnosis of hyperplasia taken after the TCR

Exclusion Criteria:

• D-score < 0,

• Age < 30 or > 70,

• Increased sensitivity to progestins,

• Pregnancy,

• Infection or cancer in genitalia or mammary gland,

• Liver disease,

• Serious thrombophlebitis.