drugset / Trial / NCT06145438

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

NCT06145438

Phase 3 Completed 80 enrolled Universitas Diponegoro
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-09-04
Primary completion
2024-08-19
Completion
2024-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Dienogest Small molecule 2 mg Oral
Comparator Leuprolide Other / unclassified 3.75 mg Intramuscular
Subject etinilestradiol Unknown 30 ug Oral
Subject levonogestrel Unknown 150 ug Oral
Subject medroxyprogesterone acetate Other / unclassified 150 mg Intramuscular

Indications