Abnormal Uterine Bleeding (AUB)NCT07703488
Clinical Efficacy And Safety of Dydrogesterone In The Treatment Of Abnormal Uterine Bleeding During Puberty
An observational study of Abnormal Uterine Bleeding (AUB) and Ovulation Dysfunction, run by Guangdong Women and Children Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding (AUB), Ovulation Dysfunction
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2026to 28 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Female participants aged 10 to 19 years old with Abnormal Uterine Bleeding of Ovulatory Disorders will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Women and Children Hospital
Guangzhou, Guangong, 511400
About this study
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
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.
Read the detailed description
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.
- Keywords
- Abnormal Uterine Bleeding, Ovulation dysfunction type, Dydrogesterone, Drospirenone And Ethinylestradioare, Adolescence, Prospective Cohort
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization rate of menstruation in the sixth month after treatment
Measured: In the sixth month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start6 Jul 2026
- Primary completion28 Mar 2028 (estimated)
- Study completion28 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine Bleeding (AUB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703488
- Sponsor's protocol ID
- GuangdongWCH-Li Li06
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07703488
- Acronym / sponsor ID
- GuangdongWCH-Li Li06
- Keywords
- Abnormal Uterine Bleeding, Ovulation dysfunction type, Dydrogesterone, Drospirenone And Ethinylestradioare, Adolescence, Prospective Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 28 Mar 2028 (estimated)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female participants aged 10 to 19 years old with Abnormal Uterine Bleeding of Ovulatory Disorders will be enrolled.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normalization rate of menstruation in the sixth month after treatment
Time frame: In the sixth month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uterine Bleeding (AUB) and Ovulation Dysfunction, run by Guangdong Women and Children Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Li (+86 13631446859, lili-1406@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization rate of menstruation in the sixth month after treatment (time frame: In the sixth month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.