Effect GnRH Agonist Administration in Endometriosis Cyst Patients

Recruiting now · Phase 3

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT06525155

Run by

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

People needed

32

Starts

2024-01-02

Expected to finish

2025-02-01

Last updated by the study team

2024-11-25

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto — Jakarta, Indonesia (enrolling)

Full record on ClinicalTrials.gov

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