Endometriosis OvaryPhase 3ENDOSafeNCT06145438
Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
A Phase 3 study testing Dienogest, Depo Medroxyprogesterone acetate and Leuprolide (as Leuprolide Acetate) in people with Endometriosis Ovary, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question[s] it aims to answer are: 1. Health-related quality of life (HRQoL) 2. VAS score 3. Beta estradiol 4. TNF Alpha 5. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis Ovary
- What is being tested?
- Dienogest, Depo Medroxyprogesterone acetate and Leuprolide (as Leuprolide Acetate)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Sep 2023to 19 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient post surgical removal of endometriosis cyst Willing to participate
Who cannot join
- Use of any hormonal therapy for endometriosis within the previous 16 weeks.
- History of severe adverse drug reactions or hypersensitivity to steroid hormones.
- Failure of previous treatment with COC, DMPA used in this study.
- There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
- Smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery
The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question[s] it aims to answer are:
- Health-related quality of life (HRQoL)
- VAS score
- Beta estradiol
- TNF Alpha
- Adnexal mass recurrence
Participants will be randomized into 4 groups, each group will receive:
- Leuprolide Acetate injection/month
- Dienogest 2 mg/day
- COC (mycrogynon)/day
- DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.
Read the detailed description
- Beta estradiol level is measured in the serum, before and after treatment
- TNF alpha is measured in the serum, before and after treatment
- Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30)
- VAS score will be recorded before and after treatment
- Adnexal massa recurrence evaluation using USG
- Conditions
- Endometriosis Ovary
- Being tested
- Dienogest, Depo Medroxyprogesterone acetate, Leuprolide (as Leuprolide Acetate), Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Also called Nelandoz
Drug is administered orally at the same time every day
Depo Medroxyprogesterone acetateDrug
Also called Depo Provera
Drug is injected intramuscularly on the buttock
Leuprolide (as Leuprolide Acetate)Drug
Also called Tapros
Drug is injected intramuscularly on the buttock
Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)Drug
Also called Combined oral contraceptive
Drug is administered orally at the same time every day
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Acetate | Active comparator | Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months Receives: Drug: Leuprolide (as Leuprolide Acetate) |
| Dienogest | Experimental | Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months Receives: Drug: Dienogest |
| Depot medroxyprogesterone acetate | Experimental | Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months Receives: Drug: Depo Medroxyprogesterone acetate |
| Combined Oral Contraceptive | Experimental | Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months Receives: Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta estradiol level
Measuring beta estradiol level on the serum
Measured: 0 and 12 weeks of treatment
TNF alpha level
Measuring TNF alpha level on the serum
Measured: 0 and 12 weeks of treatment
Secondary outcomes (3)
VAS score
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum. 0 means "no pain" and 10 means"worst pain
Measured: 0 and 12 weeks of treatment
health-related quality of life (HRQoL)
Endometriosis Health Profile-30 (EHP-30). It consists of 30 items to which respondents can choose between the answers: Never (0); Rarely (1), Sometimes (2); Often (3); and Always (4). The 30 items are divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. Each scale is standardized on a scale from 0 to 100, with lower scores indicating better QoL
Measured: 0 and 12 weeks of treatment
Mass recurrence
Evaluate the adnexal mass using Ultrasound after completing treatment
Measured: 0 and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start4 Sep 2023
- Primary completion19 Aug 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis OvaryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuli Trisetiyono, Universitas Diponegoro
- Investigators
- Yuli Trisetiyono, SpOG (K), Principal investigator, Diponegoro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145438
- Sponsor's protocol ID
- 00000088
- Acronym
- ENDOSafe
- Status last verified
- Dec 2024
- First submitted
- 22 Oct 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery
- ClinicalTrials.gov ID
- NCT06145438
- Acronym / sponsor ID
- ENDOSafe / 00000088
- Conditions
- Endometriosis Ovary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 24 Nov 2023 (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.
The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question[s] it aims to answer are:
- Health-related quality of life (HRQoL)
- VAS score
- Beta estradiol
- TNF Alpha
- Adnexal mass recurrence
Participants will be randomized into 4 groups, each group will receive:
- Leuprolide Acetate injection/month
- Dienogest 2 mg/day
- COC (mycrogynon)/day
- DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.
Detailed description
- Beta estradiol level is measured in the serum, before and after treatment
- TNF alpha is measured in the serum, before and after treatment
- Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30)
- VAS score will be recorded before and after treatment
- Adnexal massa recurrence evaluation using USG
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Leuprolide Acetate | Active comparator | Drug: Leuprolide (as Leuprolide Acetate)Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months |
| Dienogest | Experimental | Drug: DienogestDienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months |
| Depot medroxyprogesterone acetate | Experimental | Drug: Depo Medroxyprogesterone acetateDepot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months |
| Combined Oral Contraceptive | Experimental | Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient post surgical removal of endometriosis cyst Willing to participate
Key exclusion criteria (5 listed)
- Use of any hormonal therapy for endometriosis within the previous 16 weeks.
- History of severe adverse drug reactions or hypersensitivity to steroid hormones.
- Failure of previous treatment with COC, DMPA used in this study.
- There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
- Smoker.
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 |
|---|---|---|
| DienogestAlso: NelandozDrug is administered orally at the same time every day | Drug | Dienogest |
| Depo Medroxyprogesterone acetateAlso: Depo ProveraDrug is injected intramuscularly on the buttock | Drug | Depot medroxyprogesterone acetate |
| Leuprolide (as Leuprolide Acetate)Also: TaprosDrug is injected intramuscularly on the buttock | Drug | Leuprolide Acetate |
| Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)Also: Combined oral contraceptiveDrug is administered orally at the same time every day | Drug | Combined Oral Contraceptive |
Primary outcome
beta estradiol level
Time frame: 0 and 12 weeks of treatment
Measuring beta estradiol level on the serum
TNF alpha level
Time frame: 0 and 12 weeks of treatment
Measuring TNF alpha level on the serum
3 secondary outcomes
VAS score
Time frame: 0 and 12 weeks of treatment
health-related quality of life (HRQoL)
Time frame: 0 and 12 weeks of treatment
Mass recurrence
Time frame: 0 and 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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. This study is not recruiting at the moment.
Yuli Trisetiyono, SpOG (K) principal investigator
Diponegoro University
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 Dienogest, Depo Medroxyprogesterone acetate and Leuprolide (as Leuprolide Acetate) in people with Endometriosis Ovary, run by Universitas Diponegoro 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
beta estradiol level (time frame: 0 and 12 weeks of treatment). The study lists 2 primary outcomes in all. 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 11 Dec 2024.