NCT03992937

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Hyperplasia Without Atypia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-20
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-06-20
• Last updated: 2020-12-02

Locations

1 site across 1 country: Turkey (Türkiye)