Effect GnRH Agonist Administration in Endometriosis Cyst Patients

NCT ID: NCT06525155

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-02-28

Brief Summary

Endometriosis is a chronic disease that affects 10-15% of women of childbearing age. The most common symptom is pelvic pain. One of the treatment options that has been proven effective in treating endometriosis symptoms, including endometriosis pain, is triptorelin. Triptorelin has also received a distribution permit in Indonesia for the treatment of endometriosis.

However, patient compliance in using this drug is very low due to high medical costs and side effects of the drug. Standard treatment with triptorelin is generally given every 4 weeks. A previous preliminary study showed that triptorelin could be given at 6-week interval and provided treatment results that were no different from those at 4-week interval. This is certainly better, because with longer interval doses it can reduce medical costs, reduce side effects due to hormone suppression and can increase patient compliance in undergoing treatment. Therefore, in this study triptorelin will be given to 2 groups and observed for 18 weeks. The first group will be given triptorelin twice before surgery, each with an interval of 6 weeks, at baseline and week-6. Then triptorelin will be given again once after surgery at week-12. In the second group, triptorelin will be given once after surgery at week-12. In this study, the effect of triptorelin on the treatment of endometriosis will be measured based on the improvement in the degree of pain felt by the subjects using a visual analogue scale (VAS) at baseline, week-6, week-12 (prior to surgery) and week-18; Anti Mullerian Hormone (AMH) levels, and estradiol levels before triptorelin administration (at baseline) and prior to surgery (week-12). The condition of the uterus and cysts will also be evaluated at the time of surgery.

Detailed Description

There will be 2 groups of treatment; each group will consist of 16 subjects with study period for 18 weeks.

Treatment I : twice before surgery (baseline and week-6) and once after surgery at week-12 Treatment II : once after surgery at week-12

The eligible subjects will be allocated to receive study medication (Treatment 1 or Treatment 2) in an open label study. They will be asked to come to the hospital every 6-week interval throughout the study period.

Subjects will be evaluated based on the improvement in the degree of pain felt by the subjects using a visual analogue scale (VAS) on each visit throughout the study period (at baseline, week-6, week-12 prior to surgery and week-18), and Anti Mullerian Hormone (AMH) levels and estradiol levels at baseline and week-12 (prior to surgery). The condition of the uterus and cysts will also be evaluated at the time of surgery at week-12.

Conditions

Endometriosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment 1

Triptorelin Embonate, 3 times dosing

Group Type: EXPERIMENTAL

Triptorelin Embonate

Intervention Type: DRUG

Treatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12

Treatment 2

Triptorelin Embonate, 1 time dosing

Group Type: EXPERIMENTAL

Triptorelin Embonate

Intervention Type: DRUG

Treatment 2: 3.75 mg once after surgery at week-12

Interventions

Triptorelin Embonate

Treatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12

Intervention Type: DRUG

Triptorelin Embonate

Treatment 2: 3.75 mg once after surgery at week-12

Intervention Type: DRUG

Other Intervention Names

Pamorelin; Pamorelin

Eligibility Criteria

Inclusion Criteria

• Female subjects aged 18 to 40 years.
• The subjects was diagnosed with endometriosis cysts.
• Willing to participate in research and sign informed consent before all research-related activities begin.
• Regular menstruation (within 25 - 35 day intervals) in the last 3 months before the study was conducted.

Exclusion Criteria

• The patient used hormonal contraception in the last 3 months prior to the study.
• Using a GnRH agonist within the past 3 months.
• Using the hormone progesterone within the last 3 months
• Pregnancy, breastfeeding females
• History of osteoporosis
• History of blood clotting disorders
• History of heart and blood vessel disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: collaborator

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

OTHER

Sponsor Role: lead

Responsible Party

Surya Adi Pramono

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Surya A Pramono, Sp.OG., Subsp.FER, MD

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Locations

Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto

Jakarta, , Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Surya A Pramono, Sp.OG., Subsp.FER, MD

Role: CONTACT

suryaadipramono230781@gmail.com

+6282145122104

Facility Contacts

Surya A Pramono, Sp.OG., Subsp.FER

Role: primary

suryaadipramono230781@gmail.com

+6282145122104

Other Identifiers

PMR0123

Identifier Type: -

Identifier Source: org_study_id