NCT06525155 Effect GnRH Agonist Administration in Endometriosis Cyst Patients
| NCT ID | NCT06525155 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 32 participants in total. It began in 2024-01-02 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Surya A Pramono, Sp.OG., Subsp.FER, MD
PRINCIPAL INVESTIGATOR
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Frequently Asked Questions
Who can join the NCT06525155 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06525155 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 32 participants.
Is NCT06525155 currently recruiting?
Yes, NCT06525155 is actively recruiting participants. Contact the research team at suryaadipramono230781@gmail.com for enrollment information.
Where is the NCT06525155 trial being conducted?
This trial is being conducted at Jakarta, Indonesia.
Who is sponsoring the NCT06525155 clinical trial?
NCT06525155 is sponsored by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto. The principal investigator is Surya A Pramono, Sp.OG., Subsp.FER, MD at Rumah Sakit Pusat Angkatan Darat Gatot Soebroto. The trial plans to enroll 32 participants.