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 menstrual cycle patterns and examination findings. The findings may help clarify the comparative effectiveness and safety of these two hormonal regimens for long-term cycle management in adolescents with AUB-O.
Eligibility
Sex
FEMALE
Min age
10 Years
Max age
19 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Normalization rate of menstruation in the sixth month after treatment — In the sixth month after treatment
Trial sites (1)
Facility
City
Region
Status
Guangdong Women and Children Hospital
Guangzhou
Guangong
Recruiting
More Guangdong Women and Children Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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