Skip to main content
OpenTrials
Completed

NCT Number: NCT06145438

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis Ovary

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kariadi Hospital

Semarang, Central Java, 50244, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient post surgical removal of endometriosis cyst Willing to participate

Exclusion criteria

  • Use of any hormonal therapy for endometriosis within the previous 16 weeks.
  • History of severe adverse drug reactions or hypersensitivity to steroid hormones.
  • Failure of previous treatment with COC, DMPA used in this study.
  • 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.
  • Smoker.

Treatment and study plan

Dienogest

Drug

Drug is administered orally at the same time every day

Other names: Nelandoz

Depo Medroxyprogesterone acetate

Drug

Drug is injected intramuscularly on the buttock

Other names: Depo Provera

Leuprolide (as Leuprolide Acetate)

Drug

Drug is injected intramuscularly on the buttock

Other names: Tapros

Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)

Drug

Drug is administered orally at the same time every day

Other names: Combined oral contraceptive

Primary outcomes

  1. beta estradiol level

    Time frame: 0 and 12 weeks of treatment

    Measuring beta estradiol level on the serum

  2. TNF alpha level

    Time frame: 0 and 12 weeks of treatment

    Measuring TNF alpha level on the serum

Secondary outcomes

  1. VAS score

    Time frame: 0 and 12 weeks of treatment

    Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum. 0 means "no pain" and 10 means"worst pain

  2. health-related quality of life (HRQoL)

    Time frame: 0 and 12 weeks of treatment

    Endometriosis Health Profile-30 (EHP-30). It consists of 30 items to which respondents can choose between the answers: Never (0); Rarely (1), Sometimes (2); Often (3); and Always (4). The 30 items are divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. Each scale is standardized on a scale from 0 to 100, with lower scores indicating better QoL

  3. Mass recurrence

    Time frame: 0 and 12 weeks of treatment

    Evaluate the adnexal mass using Ultrasound after completing treatment

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study title

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

Acronym: ENDOSafe

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.