Effect GnRH Agonist Administration in Endometriosis Cyst Patients

November 21, 2024 updated by: Surya Adi Pramono, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There will be 2 groups of treatment; each group will consist of 16 subjects with study period for 18 weeks.

Treatment I : twice before surgery (baseline and week-6) and once after surgery at week-12 Treatment II : once after surgery at week-12

The eligible subjects will be allocated to receive study medication (Treatment 1 or Treatment 2) in an open label study. They will be asked to come to the hospital every 6-week interval throughout the study period.

Subjects will be evaluated based on the improvement in the degree of pain felt by the subjects using a visual analogue scale (VAS) on each visit throughout the study period (at baseline, week-6, week-12 prior to surgery and week-18), and Anti Mullerian Hormone (AMH) levels and estradiol levels at baseline and week-12 (prior to surgery). The condition of the uterus and cysts will also be evaluated at the time of surgery at week-12.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10410
        • Recruiting
        • Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
Triptorelin Embonate, 3 times dosing
Drug: Triptorelin Embonate
Treatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12
Other Names:
  • Pamorelin
Drug: Triptorelin Embonate
Treatment 2: 3.75 mg once after surgery at week-12
Other Names:
  • Pamorelin
Experimental: Treatment 2
Triptorelin Embonate, 1 time dosing
Drug: Triptorelin Embonate
Treatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12
Other Names:
  • Pamorelin
Drug: Triptorelin Embonate
Treatment 2: 3.75 mg once after surgery at week-12
Other Names:
  • Pamorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti Mullerian Hormones (AMH) levels
Time Frame: Baseline, week-12 (prior to surgery)
Hormone which is produced by ovarian follicles indirectly represent remaining ovarian reserves.
Baseline, week-12 (prior to surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: Baseline, week-6, week-12, week-18
Pain intensity measurement tool and presented in the form of a horizontal line and given a number 0-10.
Baseline, week-6, week-12, week-18
Estradiol levels
Time Frame: Baseline, week-12 (prior to surgery)
Estradiol is a sex hormone that has proinflammatory and anti-apoptotic effects on endometrial cells which can exacerbate endometriosis.
Baseline, week-12 (prior to surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Collaborators

Dexa Medica Group

Investigators

  • Principal Investigator: Surya A Pramono, Sp.OG., Subsp.FER, MD, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMR0123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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