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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Hyperplasia Without Atypia

Intervention / Treatment
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* Drug: Vaginal Micronized Progesterone
* Device: Levonorgestrel-Intrauterine System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Micronized Progesterone<br>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<br>* 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.<br>|
| Active Comparator: LNG-IUS<br>Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up. | Device: Levonorgestrel-Intrauterine System<br>* Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.<br>* Other names: Mirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 month | 
| 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 | 6 month |