EndometriosisPhase 3NCT06525155
Effect GnRH Agonist Administration in Endometriosis Cyst Patients
A Phase 3 study testing Triptorelin Embonate in people with Endometriosis, run by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Triptorelin Embonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Jan 2024to Feb 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology Central Army Hospital Gatot Soebroto
Jakarta, 10410
Surya A Pramono, Sp.OG., Subsp.FER, +6282145122104, suryaadipramono230781@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Triptorelin Embonate
- Keywords
- Triptorelin embonate, Endometriosis cyst
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin EmbonateDrug
Also called Pamorelin
Treatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12
Triptorelin EmbonateDrug
Also called Pamorelin
Treatment 2: 3.75 mg once after surgery at week-12
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Triptorelin Embonate, 3 times dosing Receives: Drug: Triptorelin Embonate |
| Treatment 2 | Experimental | Triptorelin Embonate, 1 time dosing Receives: Drug: Triptorelin Embonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Mullerian Hormones (AMH) levels
Hormone which is produced by ovarian follicles indirectly represent remaining ovarian reserves.
Measured: Baseline, week-12 (prior to surgery)
Secondary outcomes (2)
Visual Analogue Scale (VAS)
Pain intensity measurement tool and presented in the form of a horizontal line and given a number 0-10.
Measured: Baseline, week-6, week-12, week-18
Estradiol levels
Estradiol is a sex hormone that has proinflammatory and anti-apoptotic effects on endometrial cells which can exacerbate endometriosis.
Measured: Baseline, week-12 (prior to surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start2 Jan 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
- Sponsor type
- University, hospital or other
- Collaborators
- Dexa Medica Group
- Responsible party
- Principal investigator, Surya Adi Pramono, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
- Investigators
- Surya A Pramono, Sp.OG., Subsp.FER, MD, Principal investigator, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525155
- Sponsor's protocol ID
- PMR0123
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GnRH Agonist Administration on Decreasing VAS, Estradiol, and Anti Mullerian Hormone in Endometriosis Cyst Patients
- ClinicalTrials.gov ID
- NCT06525155
- Acronym / sponsor ID
- PMR0123
- Conditions
- Endometriosis
- Keywords
- Triptorelin embonate, Endometriosis cyst
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Rumah Sakit Pusat Angkatan Darat Gatot SoebrotoUniversity, hospital or other
- Collaborators
- Dexa Medica Group
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: Triptorelin EmbonateTriptorelin Embonate, 3 times dosing |
| Treatment 2 | Experimental | Drug: Triptorelin EmbonateTriptorelin Embonate, 1 time dosing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin EmbonateAlso: PamorelinTreatment 1: 3.75 mg twice before surgery (baseline and week-6) and once after surgery at week-12 | Drug | Treatment 1 |
| Triptorelin EmbonateAlso: PamorelinTreatment 2: 3.75 mg once after surgery at week-12 | Drug | Treatment 2 |
Primary outcome
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.
2 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Baseline, week-6, week-12, week-18
Estradiol levels
Time frame: Baseline, week-12 (prior to surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Surya A Pramono, Sp.OG., Subsp.FER, MD principal investigator
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin Embonate in people with Endometriosis, run by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surya A Pramono, Sp.OG., Subsp.FER, MD (+6282145122104, suryaadipramono230781@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Mullerian Hormones (AMH) levels (time frame: Baseline, week-12 (prior to surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.