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

Endometrial Hyperplasia Without Atypia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992937
• Other study ID #: VMP vs LNG
• Status: Completed
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Endometrial Hyperplasia Without Atypia
• Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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