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

Universitas Diponegoro

Status and phase: Completed; Phase 3

Conditions: Endometriosis Ovary

Treatments: Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon); Drug: Dienogest; Drug: Leuprolide (as Leuprolide Acetate); Drug: Depo Medroxyprogesterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT06145438

00000088

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Leuprolide Acetate

Active Comparator group

Description:

Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months

Treatment:

Drug: Leuprolide (as Leuprolide Acetate)

Dienogest

Experimental group

Description:

Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months

Treatment:

Drug: Dienogest

Depot medroxyprogesterone acetate

Experimental group

Description:

Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months

Treatment:

Drug: Depo Medroxyprogesterone acetate

Combined Oral Contraceptive

Experimental group

Description:

Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months

Treatment:

Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)