Tests how often triptorelin is given for endometriosis cysts
Tests triptorelin dosing schedules in adults with endometriosis cysts before surgery.
Key facts
- Who runs it
- Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
- Where
- Jakarta, IndonesiaSee the site
- Trial code
- Registry title
- Effect GnRH Agonist Administration in Endometriosis Cyst Patients
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 32 people, planned
- Started
- 2 Jan 2024
- Planned end
- Feb 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Triptorelin Embonate
- Record updated
- 25 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 40 with an endometriosis cyst and regular periods. It tests how a hormone drug (triptorelin) affects pain and hormone levels.
- Age
- 18 to 40 years
- Sex
- Women only
- Disease stage
- Diagnosed with an endometriosis cyst
- Earlier treatment
- Must not have used hormonal contraception, a GnRH agonist or progesterone in the last 3 months.
Main reasons for not taking part
- Hormonal contraception, GnRH agonist or progesterone in the last 3 months
- Pregnant or breastfeeding
- History of osteoporosis
- History of blood clotting disorders
- History of heart and blood vessel disorders
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- The patient used hormonal contraception in the last 3 months prior to the study
- History of osteoporosis
- History of blood clotting disorders
- History of heart and blood vessel disorders
- Using a GnRH agonist within the past 3 months
- Using the hormone progesterone within the last 3 months
- Pregnancy, breastfeeding females
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Where in Indonesia
- Department of Obstetrics and Gynecology Central Army Hospital Gatot SoebrotoJakarta, IndonesiaContact: Surya A Pramono, Sp.OG., Subsp.FERTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Treatment 1Treatment being tested
Triptorelin Embonate, 3 times dosing
Treatment: Triptorelin Embonate
- Treatment 2Treatment being tested
Triptorelin Embonate, 1 time dosing
Treatment: Triptorelin Embonate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of GnRH Agonist Administration on Decreasing VAS, Estradiol, and Anti Mullerian Hormone in Endometriosis Cyst Patients
- Plain-language title
- Tests how often triptorelin is given for endometriosis cystsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06525155, who can take part
- Record updated
- 25 November 2024