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

NCT07703488 | Recruiting

• 1 other identifier: GuangdongWCH-Li Li06
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abnormal Uterine Bleeding (AUB); Ovulation Dysfunction

Keywords

Abnormal Uterine Bleeding; Ovulation dysfunction type; Dydrogesterone; Drospirenone And Ethinylestradioare; Adolescence; Prospective Cohort

Outcome Measures

Primary Outcomes (1)

• Normalization rate of menstruation in the sixth month after treatment

  In the sixth month after treatment

Study Arms (2)

Dydrogesterone

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

COC

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

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, Guangong, 511400, China

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Li Li

CONTACT

+86 13631446859; lili-1406@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): March 28, 2028
• Study Completion (Estimated): July 28, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

CN (1)