NCT06145438CompletedPhase 3
Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
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. Adnexal mass recurrence Participants will be randomized into 4 groups, each group will receive: 1. Leuprolide Acetate injection/month 2. Dienogest 2 mg/day 3. COC (mycrogynon)/day 4. DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 22 Oct 2023
- Start date
- 4 Sept 2023
- Primary completion date
- 19 Aug 2024
- Lead sponsor
- Universitas Diponegoro
- Diseases
- Endometriosis
- NCT number
- NCT06145438
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 80
- From 4 Sept 2023 to the primary completion date, 19 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any hormonal therapy for endometriosis within the previous 16 weeks.
- Failure of previous treatment with COC, DMPA used in this study.
Other illness
- History of severe adverse drug reactions or hypersensitivity to steroid hormones.
- 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.
Other
- Smoker.
Who the study is looking for
- Patient post surgical removal of endometriosis cyst Willing to participate
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kariadi Hospital Coordinator of this site? Confirm its status | Semarang | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.