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Clinical Efficacy And Safety of Dydrogesterone In The Treatment Of Abnormal Uterine Bleeding During Puberty

Recruitingn/aAges 10 Years - 19 YearsFemaleGuangdong Women and Children Hospital
NCT07703488 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This multicenter prospective cohort study evaluates the clinical efficacy and safety of dydrogesterone versus drospirenone and ethinylestradiol in adolescents aged 10-19 years with abnormal uterine bleeding-ovulatory dysfunction (AUB-O). Patients who meet the FIGO PALM-COEIN criteria for AUB-O, have complete baseline clinical data, and provide guardian consent with adolescent assent are enrolled. Participants are allocated to receive either dydrogesterone or drospirenone and ethinylestradiol according to routine clinical practice. The primary outcome is the 6-month menstrual normalization rate (cycle length 21-35 days). Secondary outcomes include breakthrough bleeding, recurrence, adverse events, and quality-of-life improvements. Follow-up is conducted during treatment and for 6 months after treatment cessation, during which menstrual normalization is evaluated based on changes in menstr

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female patient between 10-19 years old, already experiencing menarche and at least 6 months away from menarche * According with the criteria of Abnormal Uterine Bleeding of Ovulatory Disorders: irregular menstrual cycles (cycle interval\<21 days or\>45 days, or adjacent menstrual intervals\>90 days), prolonged menstrual periods (\>7 days), excessive menstrual flow, poor bleeding control (score\>100 on the menstrual bleeding assessment scale, or a significant increase in the frequency of changing hygiene products) within the past 3 months, and has ruled out pregnancy related and obvious structural causes. * The guardian of the subject signs the informed consent and obtains the consent of the subject. * With complete baseline clinical data: complete blood count, serum ferritin, Six types of sex hormones(FSH, LH, E2, P, T, PRL), Gynecological Sonography. Exclusion Criteria: * Coagulation disorder * Requiring long-term anticoagulant and antiplatelet therapy * Secondary Abnormal Uterine Bleeding caused by uncontrolled hyperthyroidism, hypothyroidism, hyperprolactinemia, or other endocrine diseases. * Dysfunction of kidney and liver, or a history of severe intolerance or allergy to dydrogesterone, medroxyprogesterone, or other progestogens.
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What it tests

  • Not listed
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Where

1 site
Guangdong Women and Children Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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