CompletedPhase 3

Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

Indonesia80 participantsStarted 2023-09-04

Plain-language 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. 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.

Who can participate

SexFEMALE

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Exclusion criteria

✕. 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.

What they're measuring

beta estradiol level

Timeframe: 0 and 12 weeks of treatment

TNF alpha level

Timeframe: 0 and 12 weeks of treatment

Trial details

NCT IDNCT06145438

SponsorUniversitas Diponegoro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-19

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