Effect of GnRH Agonist Administration on Decreasing VAS, Estradiol, and Anti Mullerian Hormone in Endometriosis Cyst Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto
RECRUITING
Jakarta
Contact Information
Primary
Surya A Pramono, Sp.OG., Subsp.FER, MD
suryaadipramono230781@gmail.com
+6282145122104
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2025-02
Participants
Target number of participants: 32
Treatments
Experimental: Treatment 1
Triptorelin Embonate, 3 times dosing
Experimental: Treatment 2
Triptorelin Embonate, 1 time dosing
Related Therapeutic Areas
Sponsors
Leads: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Collaborators: Dexa Medica Group

This content was sourced from clinicaltrials.gov

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