Ovulatory Dysfunction–Related Abnormal Uterine Bleeding in Adolescents
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1.A confirmed diagnosis of abnormal uterine bleeding due to ovulatory dysfunction (AUB-O); 2.Aged 10–19 years (according to the definition of adolescence), with at least one year since menarche; 3.Clear evidence that the bleeding originates from the uterine cavity, rather than from extrauterine sites such as the urethra, anus, vagina, or cervix; 4.Meeting any one of the following criteria: (1) Abnormal menstrual cycle frequency: Irregular menstruation within the first year after menarche is considered a normal transitional phenomenon; From 1 to 3 years after menarche, menstrual cycles 45 days; From =3 years after menarche until the perimenopausal period, menstrual cycles 35 days, or fewer than 8 menstrual cycles per year; More than 1 year after menarche, any single menstrual cycle >90 days; (2) Abnormal menstrual blood loss: Menstrual blood loss >80 mL or <20 mL per cycle; Subjective perception of heavy menstrual bleeding affecting quality of life, or a noticeable reduction in menstrual volume compared with previous cycles, presenting as spotting; (3) Abnormal duration of menstruation: Menstrual bleeding lasting longer than 7 days; (4) Amenorrhea: Primary amenorrhea: absence of menarche by age 15 years, or no menstruation more than 3 years after the onset of breast development; Secondary amenorrhea: cessation of menstruation for three consecutive cycles or for more than 6 months after menarche.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1.Prepubertal abnormal uterine bleeding caused by precocious puberty, other underlying diseases, or medication use; 2.Pregnancy or pregnancy-related bleeding; 3.Abnormal uterine bleeding caused by uterine structural abnormalities, localized endometrial lesions, coagulation disorders, or iatrogenic factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients achieving regular menstruation after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex hormone levels;Complete blood count parameters;Improvement in menstrual symptoms;Pictorial Blood Assessment Chart (PBAC);Psychological status;Sleep status; | — |
Countries
China
Contacts
Institute Of Basic Research In Clinical Medicine China Academy Of Chinese Medical Sciences