RecruitingNCT07703488

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

Clinical Efficacy and Quality of Life Assessment of Dydrogesterone in Managing Abnormal Uterine Bleeding of Ovulatory Disorders in Adolescents:A Multicenter Prospective Cohort Study


Sponsor

Guangdong Women and Children Hospital

Enrollment

240 participants

Start Date

Jul 6, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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: FEMALEMin Age: 10 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with abnormal uterine bleeding (aub) and ovulation dysfunction. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 10 Years to 19 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Guangdong Women and Children Hospital

Guangzhou, Guangong, China

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NCT07703488


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