Effect GnRH Agonist Administration in Endometriosis Cyst Patients

NCT06525155 | Recruiting Phase 3

• 1 other identifier: PMR0123
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Triptorelin embonate; Endometriosis cyst

Outcome Measures

Primary Outcomes (1)

• Anti Mullerian Hormones (AMH) levels

  Hormone which is produced by ovarian follicles indirectly represent remaining ovarian reserves.

  Baseline, week-12 (prior to surgery)

Secondary Outcomes (2)

• Visual Analogue Scale (VAS)

  Baseline, week-6, week-12, week-18

• Estradiol levels

  Baseline, week-12 (prior to surgery)

Study Arms (2)

Treatment 1

EXPERIMENTAL

Triptorelin Embonate, 3 times dosing

Drug: Triptorelin Embonate

Treatment 2

EXPERIMENTAL

Triptorelin Embonate, 1 time dosing

Drug: Triptorelin Embonate

Interventions

Triptorelin Embonate DRUG

Treatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12

Also known as: Pamorelin

Treatment 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto: lead
• Dexa Medica Group: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto

Jakarta, 10410, Indonesia

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

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

  Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+6282145122104; suryaadipramono230781@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: January 2, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

ID (1)