A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia - Full Text View

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:

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

Drug Information available for: Medroxyprogesterone acetate Levonorgestrel

U.S. FDA Resources

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

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:

Centre of competence for endometrial hyperplasia, University Hospital of Tromsø, Norway This link exits the ClinicalTrials.gov site

Publications:

Kurman RJ, Kaminski PF, Norris HJ. The behavior of endometrial hyperplasia. A long-term study of "untreated" hyperplasia in 170 patients. Cancer. 1985 Jul 15;56(2):403-12.

Ferenczy A, Gelfand M. The biologic significance of cytologic atypia in progestogen-treated endometrial hyperplasia. Am J Obstet Gynecol. 1989 Jan;160(1):126-31.

Orbo A, Baak JP, Kleivan I, Lysne S, Prytz PS, Broeckaert MA, Slappendel A, Tichelaar HJ. Computerised morphometrical analysis in endometrial hyperplasia for the prediction of cancer development. A long-term retrospective study from northern Norway. J Clin Pathol. 2000 Sep;53(9):697-703.

Vereide AB, Arnes M, Straume B, Maltau JM, Ørbo A. Nuclear morphometric changes and therapy monitoring in patients with endometrial hyperplasia: a study comparing effects of intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol. 2003 Dec;91(3):526-33.

Nilsson CG, Haukkamaa M, Vierola H, Luukkainen T. Tissue concentrations of levonorgestrel in women using a levonorgestrel-releasing IUD. Clin Endocrinol (Oxf). 1982 Dec;17(6):529-36.

Scarselli G, Tantini C, Colafranceschi M, Taddei GL, Bargelli G, Venturini N, Branconi F. Levo-norgestrel-nova-T and precancerous lesions of the endometrium. Eur J Gynaecol Oncol. 1988;9(4):284-6.

Ørbo A, Arnes M, Hancke C, Vereide AB, Pettersen I, Larsen K. Treatment results of endometrial hyperplasia after prospective D-score classification: a follow-up study comparing effect of LNG-IUD and oral progestins versus observation only. Gynecol Oncol. 2008 Oct;111(1):68-73. Epub 2008 Aug 6.

Baak JP, Nauta JJ, Wisse-Brekelmans EC, Bezemer PD. Architectural and nuclear morphometrical features together are more important prognosticators in endometrial hyperplasias than nuclear morphometrical features alone. J Pathol. 1988 Apr;154(4):335-41.

Perino A, Quartararo P, Catinella E, Genova G, Cittadini E. Treatment of endometrial hyperplasia with levonorgestrel releasing intrauterine devices. Acta Eur Fertil. 1987 Mar-Apr;18(2):137-40.

Vereide AB, Kaino T, Sager G, Ørbo A; Scottish Gynaecological Clinical Trials Group. Bcl-2, BAX, and apoptosis in endometrial hyperplasia after high dose gestagen therapy: a comparison of responses in patients treated with intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol. 2005 Jun;97(3):740-50.

Vereide AB, Kaino T, Sager G, Arnes M, Ørbo A. Effect of levonorgestrel IUD and oral medroxyprogesterone acetate on glandular and stromal progesterone receptors (PRA and PRB), and estrogen receptors (ER-alpha and ER-beta) in human endometrial hyperplasia. Gynecol Oncol. 2006 May;101(2):214-23. Epub 2005 Dec 1.

Moe BT, Vereide AB, Orbo A, Jaeger R, Sager G. Levonorgestrel, medroxyprogesterone and progesterone cause a concentration-dependent reduction in endometrial cancer (Ishikawa) cell density, and high concentrations of progesterone and mifepristone act in synergy. Anticancer Res. 2009 Apr;29(4):1047-52.

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
Adenoma
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Levonorgestrel
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins

Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013