An observational study in Abnormal Uterine Bleeding (AUB) and Ovulation Dysfunction, sponsored by Guangdong Women and Children Hospital. Recruiting at 1 site in China. Open to female participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Guangdong Women and Children Hospital · Observational
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.
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 are included if they meet the International Federation of Gynecology and Obstetrics (FIGO) PALM-COEIN criteria for AUB-O, have complete baseline clinical data (complete blood count, serum ferritin, thyroid function, sex hormone panel, coagulation profile, and pelvic ultrasonography), and provide guardian consent with adolescent assent. Patients with uncontrolled coagulation disorders, unstable endocrine conditions (e.g., untreated thyroid dysfunction or hyperprolactinemia), significant hepatic or renal impairment, or known hypersensitivity to progestins are excluded. Eligible participants are allocated to receive either dydrogesterone or drospirenone and ethinylestradiol according to routine clinical practice. The primary objective is to compare the 6-month menstrual normalization rate (cycle length 21-35 days) between the two groups. Secondary objectives include changes in menstrual blood loss, hemoglobin and ferritin levels, recurrence after treatment discontinuation, time to hemostasis, quality-of-life improvements (assessed by the adolescent-version menstrual bleeding questionnaire), and safety outcomes (adverse events and laboratory monitoring). Follow-up at 6 months focuses on menstrual normalization and quality-of-life improvement. Clinical, demographic, and disease-related characteristics (age, age at menarche, body mass index, baseline bleeding severity, anemia and iron status, endocrine/metabolic factors, adherence, and family support) are collected from medical records and visit data. Because this is an observational cohort study, no intervention is randomly assigned; treatment decisions are based on standard clinical practice. The study aims to assess the comparative effectiveness and safety of the two hormonal regimens for long-term cycle regulation in adolescents with AUB-O. Multivariable regression and propensity score weighting will be used to adjust for potential confounders and center effects, with subgroup and sensitivity analyses, and multiple imputation for missing data. The results are expected to provide real-world evidence to guide hormonal management in this population.
153 studies on the registry are indexed under Metrorrhagia; 35 are open to participants now.
This study's planned enrollment of 240 is above the median of 171 across 33 observational studies indexed under Metrorrhagia.
Browse Metrorrhagia studies →Guangdong Women and Children Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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Female participants aged 10 to 19 years old with Abnormal Uterine Bleeding of Ovulatory Disorders will be enrolled.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who meet the AUB-O diagnosis in the PALM-COEIN etiological classification proposed by the International Union of Obstetrics and Gynecology and are planning to receive or have started treatment with dydrogesterone according to clinical routine
Participants who meet the AUB-O diagnosis in the PALM-COEIN etiological classification proposed by the International Union of Obstetrics and Gynecology and are planning to receive or have started treatment with rospirenone and ethinylestradioare(combined oral contraceptives, COC) according to clinical routine
Normalization rate of menstruation in the sixth month after treatment
Time frame: In the sixth month after treatment
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Guangdong Women and Children Hospital