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出境医 / 临床实验 / Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia

Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia

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.

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Without Atypia Drug: Vaginal Micronized Progesterone Device: Levonorgestrel-Intrauterine System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Vaginal Micronized Progesterone
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
 Drug: Vaginal Micronized Progesterone
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.
Active Comparator: LNG-IUS
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
 Device: Levonorgestrel-Intrauterine System
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
Other Name: Mirena
Outcome Measures
Primary Outcome Measures :
  1. Regression and remission rate of endometrial hyperplasia [ Time Frame: 3 month ]
    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 :
  1. Mean Reduction From Baseline in Menstrual Blood Loss [ Time Frame: 6 month ]
    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

  2. Number of Participants with adverse events associated with medication and device [ Time Frame: 6 month ]
    Any side effects will be recorded into questionnaire during a consultation with the patient


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Turkey
Kocaeli University
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Şener Gezer, M.D Kocaeli University
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE June 20, 2019
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Regression and remission rate of endometrial hyperplasia [ Time Frame: 3 month ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Mean Reduction From Baseline in Menstrual Blood Loss [ Time Frame: 6 month ]
    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 [ Time Frame: 6 month ]
    Any side effects will be recorded into questionnaire during a consultation with the patient
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
Official Title  ICMJE Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Hyperplasia Without Atypia
Intervention  ICMJE
  • Drug: Vaginal Micronized Progesterone
    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.
  • Device: Levonorgestrel-Intrauterine System
    Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
    Other Name: Mirena
Study Arms  ICMJE
  • Experimental: Vaginal Micronized Progesterone
    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
    Intervention: Drug: Vaginal Micronized Progesterone
  • Active Comparator: LNG-IUS
    Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
    Intervention: Device: Levonorgestrel-Intrauterine System
Publications *
  • 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.
  • Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9:CD012658. doi: 10.1002/14651858.CD012658.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2019) 		132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992937
Other Study ID Numbers  ICMJE VMP vs LNG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Şener Gezer, Kocaeli University
Study Sponsor  ICMJE Kocaeli University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Şener Gezer, M.D Kocaeli University
PRS Account Kocaeli University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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