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

Overview

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.

Full Title of Study: “Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • Active Comparator: LNG-IUS
    • Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kocaeli University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Şener Gezer, Principal Investigator – Kocaeli University
  • Overall Official(s)
    • Şener Gezer, M.D, Principal Investigator, Kocaeli University

References

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.

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