A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Helse Nord
Norwegian Cancer Society
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01074892
First received: February 23, 2010
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.

Condition Intervention Phase
Endometrial Hyperplasia
Drug: Provera (medroxyprogesterone/progestin)
Drug: Provera (medroxyprogesterone)
Device: Mirena (levonorgestrel)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Regression of hyperplasia related to treatment arm after 6 months of therapy [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of hyperplasia related to treatment arm during follow-up period [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Side effects during treatment [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Enrollment: 170
Study Start Date: May 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MPA 10 mg per oral cyclic for 6 months
The peroral treatment is used 10 days each month
Drug: Provera (medroxyprogesterone/progestin)
10 mg tablet, 1 tablet per day taken 10 days per month Duration is 6 months
Other Name: Provera
Active Comparator: MPA 10 mg per os continuous 6 months
Per oral MPA 10 mg is taken daily for 6 months
Drug: Provera (medroxyprogesterone)
10 mg per oral tablet. One tablet per day for 6 months
Other Name: Provera
Active Comparator: LNG-IUD for 6 months
Levonorgestrel impregnated IUD is inserted into the uterine cavity and kept in situ for 6 months
Device: Mirena (levonorgestrel)
Inserted in the uterine cavity and kept in situ for 6 months
Other Name: Mirena

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074892

Locations
Norway
University Hospital of North Norway
Tromsø, Troms, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
Norwegian Cancer Society
Investigators
Principal Investigator: Anne Ørbo, MD, PhD University of Tromso
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01074892     History of Changes
Other Study ID Numbers: REK nr 25/2004
Study First Received: February 23, 2010
Last Updated: May 11, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
endometrial hyperplasia treatment MPA per os LNG-IUD

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Genital Diseases, Female
Pathologic Processes
Uterine Diseases
Levonorgestrel
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014