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

Sponsor

Universitas Diponegoro (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145438

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

Health-related quality of life (HRQoL)
VAS score
Beta estradiol
TNF Alpha
Adnexal mass recurrence

Participants will be randomized into 4 groups, each group will receive:

Leuprolide Acetate injection/month
Dienogest 2 mg/day
COC (mycrogynon)/day
DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Ovary	Drug: Dienogest Drug: Depo Medroxyprogesterone acetate Drug: Leuprolide (as Leuprolide Acetate) Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Sep 4, 2023

Anticipated Primary Completion Date :

Mar 4, 2024

Anticipated Study Completion Date :

Apr 4, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

beta estradiol level [0 and 12 weeks of treatment]
Measuring beta estradiol level on the serum
TNF alpha level [0 and 12 weeks of treatment]
Measuring TNF alpha level on the serum

Secondary Outcome Measures

VAS score [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
health-related quality of life (HRQoL) [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
Mass recurrence [0 and 12 weeks of treatment]
Evaluate the adnexal mass using Ultrasound after completing treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.