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Completed

NCT Number: NCT03992937

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

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.

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Key information

Conditions

Endometrial Hyperplasia Without Atypia

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal micronized progesterone

Drug

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.

Levonorgestrel-Intrauterine System

Device

Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.

Other names: Mirena

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 20, 2019
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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