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

Not Applicable

Completed

• Conditions: Endometrial Hyperplasia Without Atypia
• Interventions: Device: Levonorgestrel-Intrauterine System; Drug: Vaginal Micronized Progesterone

• Registration Number: NCT03992937
• Lead Sponsor: Kocaeli University

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 Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-19
• Study Start: 2019-06-20
• Study First Posted: 2019-06-20
• Status Verified: 2020-12
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNG-IUS	Levonorgestrel-Intrauterine System	Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
Vaginal Micronized Progesterone	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

Primary Outcome Measures

Name	Time	Method
Regression and remission rate of endometrial hyperplasia	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

Name	Time	Method
Mean Reduction From Baseline in Menstrual Blood Loss	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	6 month	Any side effects will be recorded into questionnaire during a consultation with the patient

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey