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NCT06525155RecruitingPhase 3

Effect GnRH Agonist Administration in Endometriosis Cyst Patients

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

Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
32 (estimated)
First submitted
24 Jul 2024
Start date
2 Jan 2024
Primary completion date
Feb 2025
Lead sponsor
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
NCT number
NCT06525155

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 32
  • From 2 Jan 2024 to the primary completion date, Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient used hormonal contraception in the last 3 months prior to the study.

Other illness

  • History of osteoporosis
  • History of blood clotting disorders
  • History of heart and blood vessel disorders

Other

  • Using a GnRH agonist within the past 3 months.
  • Using the hormone progesterone within the last 3 months
  • Pregnancy, breastfeeding females

Who the study is looking for

  • 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.

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto
Coordinator of this site? Confirm its status
JakartaIndonesiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.