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

NCT06145438 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Endometriosis Ovary

Interventions

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

Sponsors & Collaborators

  • Universitas Diponegoro

    lead OTHER

Principal Investigators

  • Yuli Trisetiyono, SpOG (K) · Diponegoro University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06145438 on ClinicalTrials.gov