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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age10-19
SponsorGuangdong Women and Children Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Female participants aged 10 to 19 years old with Abnormal Uterine Bleeding of Ovulatory Disorders will be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 2 trial groups
Group A: Dydrogesterone
Group B: COC

Trial outcomes

Primary outcomes

1

Normalization rate of menstruation in the sixth month after treatment

Time frame
In the sixth month after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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