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A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia

NCT01074892 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2019-04-05

No results posted yet for this study

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.

Conditions

  • Endometrial Hyperplasia

Interventions

DRUG

Provera (medroxyprogesterone/progestin)

10 mg tablet, 1 tablet per day taken 10 days per month Duration is 6 months

DRUG

Provera (medroxyprogesterone)

10 mg per oral tablet. One tablet per day for 6 months

DEVICE

Mirena (levonorgestrel)

Inserted in the uterine cavity and kept in situ for 6 months

Sponsors & Collaborators

  • Helse Nord

    collaborator INDUSTRY

  • Norwegian Cancer Society

    collaborator OTHER

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Anne Ørbo, MD, PhD · University of Tromso

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01074892 on ClinicalTrials.gov