NCT06145438

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

Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Universitas Diponegoro · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Endometriosis Ovary

Interventions

Type	Name	Description
DRUG	Dienogest	Drug is administered orally at the same time every day
DRUG	Depo Medroxyprogesterone acetate	Drug is injected intramuscularly on the buttock
DRUG	Leuprolide (as Leuprolide Acetate)	Drug is injected intramuscularly on the buttock
DRUG	Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)	Drug is administered orally at the same time every day

Timeline

• Start date: 2023-09-04
• Primary completion: 2024-08-19
• Completion: 2024-11-19
• First posted: 2023-11-24
• Last updated: 2024-12-11

Locations

1 site across 1 country: Indonesia