Dydrogesterone vs. Drospirenone/Ethinylestradiol for Adolescents with Abnormal Uterine Bleeding-Ovulatory Dysfunction
Official title: Clinical Efficacy and Quality of Life Assessment of Dydrogesterone in Managing Abnormal Uterine Bleeding of Ovulatory Disorders in Adolescents：A Multicenter Prospective Cohort Study
Run by Guangdong Women and Children Hospital · NCT07703488 · Data updated 2026-11-12
In teens with abnormal uterine bleeding linked to ovulatory problems, researchers compare dydrogesterone to a combined birth-control pill to see which helps normalize cycles over 6 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 19 Years |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | Guangdong Women and Children Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangong) |
| Status | Recruiting |
| Started | July 6, 2026 |
| Main results expected | March 28, 2028 |
| Study ends | July 28, 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07703488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Young females aged 10–19 with AUB-O, meeting PALM-COEIN criteria, with complete baseline data and guardian consent.
✕Probably not a fit
Patients with contraindications to both study medications or who do not experience menstrual normalization may see limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational cohort study follows adolescents aged 10-19 with AUB-O to compare the clinical effects and safety of dydrogesterone versus drospirenone/ethinylestradiol, as prescribed in routine care. Participants are assigned to one of the two regimens based on standard clinical practice, and are followed during treatment and for 6 months after cessation. The primary outcome is menstrual normalization at 6 months (cycle length 21–35 days); secondary outcomes include changes in bleeding, iron parameters, recurrence, time to hemostasis, quality of life, and adverse events. Eligibility requires FIGO PALM-COEIN criteria for AUB-O, complete baseline labs, and guardian consent with adolescent assent; exclusions include coagulation disorders and certain uncontrolled conditions. The study aims to clarify comparative effectiveness and safety in a real-world setting.
Why it matters
Potential benefit: If successful, the findings could inform safer and more effective treatment choices for adolescents with AUB-O and ovulatory dysfunction.
How similar studies have gone: Previous studies in adults have explored progestin therapies for AUB with mixed results; this adolescent-focused comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Guangdong Women and Children Hospital
Guangzhou, Guangong, China Recruiting
Study contacts
- Study coordinator: Li Li
- Email: lili-1406@163.com
- Phone: +86 13631446859
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.