Actively Recruiting

Phase 3
Age: 18Years - 40Years
FEMALE
NCT06525155

Effect GnRH Agonist Administration in Endometriosis Cyst Patients

Led by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto · Updated on 2024-11-25

32

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

R

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Lead Sponsor

D

Dexa Medica Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect GnRH Agonist Administration in Endometriosis Cyst Patients

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female subjects aged 18 to 40 years
  • Diagnosed with endometriosis cysts
  • Willing to participate and sign informed consent before research activities
  • Regular menstruation with 25 to 35 day intervals for the last 3 months before the study
Not Eligible

You will not qualify if you...

  • Use of hormonal contraception within the last 3 months
  • Use of a GnRH agonist within the last 3 months
  • Use of progesterone hormone within the last 3 months
  • Pregnancy or breastfeeding
  • History of osteoporosis
  • History of blood clotting disorders
  • History of heart and blood vessel disorders

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto

Jakarta, Indonesia, 10410

Actively Recruiting

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Research Team

S

Surya A Pramono, Sp.OG., Subsp.FER, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect GnRH Agonist Administration in Endometriosis Cyst Patients | DecenTrialz