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

Recruiting now

Conditions studied: Abnormal Uterine Bleeding (AUB), Ovulation Dysfunction

In brief

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.

Key facts

Study ID

NCT07703488

Run by

Guangdong Women and Children Hospital

People needed

240

Starts

2026-07-06

Expected to finish

2028-07-28

Last updated by the study team

2026-07-14

Who can join

Age: 10 and older, up to 19. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Guangdong Women and Children Hospital — Guangzhou, Guangong, China (enrolling)

Full record on ClinicalTrials.gov

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