Comparing Dydrogesterone and Combined Oral Contraceptives for Abnormal Uterine Bleeding in Adolescents with Ovulation Disorders A Multicenter Study on Safety and Quality of Life

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of dydrogesterone compared to drospirenone and ethinylestradiol in adolescent females aged 10 to 19 years who have abnormal uterine bleeding caused by ovulatory dysfunction AUB-O. This multicenter prospective cohort study enrolls patients who meet specific diagnostic criteria and have complete baseline clinical data, including blood tests and pelvic ultrasound, with guardian consent and adolescent assent. The study aims to clarify the comparative effectiveness and safety of these two hormonal treatments for long-term menstrual cycle regulation in this population. Participants are allocated to receive either dydrogesterone or combined oral contraceptives containing drospirenone and ethinylestradiol based on routine clinical practice. The primary focus is on the rate of menstrual normalization six months after treatment, defined by cycle lengths between 21 and 35 days. Secondary outcomes include breakthrough bleeding, recurrence after stopping treatment, adverse events, and quality-of-life improvements assessed by a menstrual bleeding questionnaire. Follow-up continues during treatment and for six months after treatment ends to monitor these outcomes. Throughout the study, clinical and demographic information is collected from medical records and visits, including age, menarche age, bleeding severity, anemia status, and adherence. Participants undergo laboratory assessments such as blood counts, hormone panels, and ultrasound exams. Safety is monitored through adverse event reporting and lab tests. The total participation duration covers the treatment period plus six months of follow-up to evaluate menstrual cycle normalization and quality of life changes.

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