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

Last updated: December 6, 2024
Sponsor: Universitas Diponegoro
Overall Status: Completed

Phase

3

Condition

Endometriosis

Treatment

Depo Medroxyprogesterone acetate

Leuprolide (as Leuprolide Acetate)

Dienogest

Clinical Study ID

NCT06145438
00000088
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient post surgical removal of endometriosis cyst Willing to participate

Exclusion

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 orDienogest, 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.

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: Depo Medroxyprogesterone acetate
Phase: 3
Study Start date:
September 04, 2023
Estimated Completion Date:
November 19, 2024

Study 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

Connect with a study center

  • Kariadi Hospital

    Semarang, Central Java 50244
    Indonesia

    Site Not Available

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