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

Endometriosis Ovary Clinical Trial

— ENDOSafe  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145438
• Other study ID #: 00000088
• Status: Recruiting
• Phase: Phase 3
• Start date: September 4, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: November 2023
• Source: Universitas Diponegoro
• Contact: Yuli Trisetiyono, SpOG (K)
• Phone: +6281229007845
• Email: razmaeda[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 4, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Ovary

Intervention

Drug:
• Dienogest
Drug is administered orally at the same time every day
• Depo Medroxyprogesterone acetate
Drug is injected intramuscularly on the buttock
• Leuprolide (as Leuprolide Acetate)
Drug is injected intramuscularly on the buttock
• Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
Drug is administered orally at the same time every day

Locations

Country	Name	City	State
Indonesia	Kariadi Hospital	Semarang	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Diponegoro

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	beta estradiol level	Measuring beta estradiol level on the serum	0 and 12 weeks of treatment
Primary	TNF alpha level	Measuring TNF alpha level on the serum	0 and 12 weeks of treatment
Secondary	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
Secondary	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
Secondary	Mass recurrence	Evaluate the adnexal mass using Ultrasound after completing treatment	0 and 12 weeks of treatment