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

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis Ovary
• Intervention / Treatment: Drug: Leuprolide (as Leuprolide Acetate); Drug: Dienogest; Drug: Depo Medroxyprogesterone acetate; Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia, 50244
      • Kariadi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patient post surgical removal of endometriosis cyst Willing to participate

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 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.
5. Smoker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Leuprolide Acetate; Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months	Drug: Leuprolide (as Leuprolide Acetate); Drug is injected intramuscularly on the buttock; Other Names: Tapros
Experimental: Dienogest; Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months	Drug: Dienogest; Drug is administered orally at the same time every day; Other Names: Nelandoz
Experimental: Depot medroxyprogesterone acetate; Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months	Drug: Depo Medroxyprogesterone acetate; Drug is injected intramuscularly on the buttock; Other Names: Depo Provera
Experimental: Combined Oral Contraceptive; Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months	Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon); Drug is administered orally at the same time every day; Other Names: Combined oral contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
beta estradiol level	Measuring beta estradiol level on the serum	0 and 12 weeks of treatment
TNF alpha level	Measuring TNF alpha level on the serum	0 and 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	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	0 and 12 weeks of treatment
health-related quality of life (HRQoL)	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	0 and 12 weeks of treatment
Mass recurrence	Evaluate the adnexal mass using Ultrasound after completing treatment	0 and 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Universitas Diponegoro
• Investigators: Principal Investigator: Yuli Trisetiyono, SpOG (K), Diponegoro University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Actual): August 19, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis; Contraceptive Agents, Hormonal; Antineoplastic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Hormone Antagonists; Fertility Agents, Female; Fertility Agents; Contraceptive Agents, Female; Estrogens; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Synthetic; Contraceptive Agents, Male; Leuprolide; Medroxyprogesterone Acetate; Medroxyprogesterone; Contraceptive Agents; Ethinyl Estradiol; Contraceptives, Oral; Contraceptives, Oral, Combined; Dienogest
• Other Study ID Numbers: 00000088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make IPD and related data dictionaries available.
• IPD Sharing Time Frame: Starting in March 2024
• IPD Sharing Access Criteria: Informed Consent Form will be shared to other researchers by sending email
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No