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

Kocaeli University

Status: Completed

Conditions: Endometrial Hyperplasia Without Atypia

Treatments: Drug: Vaginal Micronized Progesterone; Device: Levonorgestrel-Intrauterine System

Study type: Interventional

Funder types: Other

Identifiers

NCT03992937

VMP vs LNG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Vaginal Micronized Progesterone

Experimental group

Description:

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

Treatment:

Drug: Vaginal Micronized Progesterone

LNG-IUS

Active Comparator group

Description:

Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.

Treatment:

Device: Levonorgestrel-Intrauterine System