Back to resultsVaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
Primary Purpose
Endometrial Hyperplasia Without Atypia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vaginal Micronized Progesterone
Levonorgestrel-Intrauterine System
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Hyperplasia Without Atypia
Eligibility Criteria
Inclusion Criteria:
- Premenopausal Patients
- Patients with histologically confirmed endometrial hyperplasia without atypia
Exclusion Criteria:
- Endometrial hyperplasia with atypia
- Endometrial Carcinoma
- Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vaginal Micronized Progesterone
LNG-IUS
Arm Description
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months. With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
Outcomes
Primary Outcome Measures
Regression and remission rate of endometrial hyperplasia
Endometrial sampling will be performed for 3'th month with Carmen canula. Pathological specimens will be reported by the specialist pathologist in accordance with the World Health Organisation (WHO) endometrial hyperplasia classification.
Secondary Outcome Measures
Mean Reduction From Baseline in Menstrual Blood Loss
Menorrhagia Impact Questionnaire (MIQ). This is a validated disease-specific patient-reported outcome questionnaire assessing menstrual blood loss and the influence of heavy menstrual bleeding on quality of life
Number of Participants with adverse events associated with medication and device
Any side effects will be recorded into questionnaire during a consultation with the patient
Full Information
NCT ID
NCT03992937
First Posted
June 14, 2019
Last Updated
December 1, 2020
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03992937
Brief Title
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
Official Title
Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.
Detailed Description
Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. In this study, we aimed to compare this local treatment with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia Without Atypia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Micronized Progesterone
Arm Type
Experimental
Arm Description
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months. With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
Arm Title
LNG-IUS
Arm Type
Active Comparator
Arm Description
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
Intervention Type
Drug
Intervention Name(s)
Vaginal Micronized Progesterone
Intervention Description
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months.
Intervention Type
Device
Intervention Name(s)
Levonorgestrel-Intrauterine System
Other Intervention Name(s)
Mirena
Intervention Description
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
Primary Outcome Measure Information:
Title
Regression and remission rate of endometrial hyperplasia
Description
Endometrial sampling will be performed for 3'th month with Carmen canula. Pathological specimens will be reported by the specialist pathologist in accordance with the World Health Organisation (WHO) endometrial hyperplasia classification.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Mean Reduction From Baseline in Menstrual Blood Loss
Description
Menorrhagia Impact Questionnaire (MIQ). This is a validated disease-specific patient-reported outcome questionnaire assessing menstrual blood loss and the influence of heavy menstrual bleeding on quality of life
Time Frame
6 month
Title
Number of Participants with adverse events associated with medication and device
Description
Any side effects will be recorded into questionnaire during a consultation with the patient
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal Patients
Patients with histologically confirmed endometrial hyperplasia without atypia
Exclusion Criteria:
Endometrial hyperplasia with atypia
Endometrial Carcinoma
Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şener Gezer, M.D
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24488582
Citation
Tasci Y, Polat OG, Ozdogan S, Karcaaltincaba D, Seckin L, Erkaya S. Comparison of the efficacy of micronized progesterone and lynestrenol in treatment of simple endometrial hyperplasia without atypia. Arch Gynecol Obstet. 2014 Jul;290(1):83-6. doi: 10.1007/s00404-014-3161-4. Epub 2014 Feb 1.
Results Reference
background
PubMed Identifier
32909630
Citation
Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2.
Results Reference
derived
Learn more about this trial
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
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