Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

Universitas Diponegoro80 enrolled

Overview

The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question\[s\] it aims to answer are: 1. Health-related quality of life (HRQoL) 2. VAS score 3. Beta estradiol 4. TNF Alpha 5. Adnexal mass recurrence Participants will be randomized into 4 groups, each group will receive: 1. Leuprolide Acetate injection/month 2. Dienogest 2 mg/day 3. COC (mycrogynon)/day 4. DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

1. Beta estradiol level is measured in the serum, before and after treatment 2. TNF alpha is measured in the serum, before and after treatment 3. Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30) 4. VAS score will be recorded before and after treatment 5. Adnexal massa recurrence evaluation using USG

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometriosis Ovary

Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: Patient post surgical removal of endometriosis cyst Willing to participate Exclusion Criteria: 1. Use of any hormonal therapy for endometriosis within the previous 16 weeks. 2. History of severe adverse drug reactions or hypersensitivity to steroid hormones. 3. Failure of previous treatment with COC, DMPA used in this study. 4. There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies. 5. Smoker.