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A prospective, randomized, controlled, open, single-center clinical study of drospirenone ethinylestradiol tablets (II) versus dydrogesterone tablets to improve the complete remission rate of endometrial hyperplasia

A prospective, randomized, controlled, open, single-center clinical study of drospirenone ethinylestradiol tablets (II) versus dydrogesterone tablets to improve the complete remission rate of endometrial hyperplasia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035184
Enrollment
Unknown
Registered
2020-08-02
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial hyperplasia

Interventions

trial group:Drospirenone ethinyl estradiol tablet (II) and Metformin
control group:Dydrogesterone and Metformin

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1)Age =45 years old (2)Endometrial sampling under hysteroscope for pathological diagnosis of endometrial hyperplasia (EH); Note: The patient underwent hysteroscopic surgery due to abnormal uterine bleeding (AUB), previous history of EH, and thickened endometrium on ultrasound; (3)Sign informed consent (4)The patient agrees to the treatment and has good compliance and can be followed up and re-intimal pathology examination;

Exclusion criteria

Exclusion criteria: (1)Diagnosis of endometrial atypical hyperplasia or endometrioid adenocarcinoma by pathological biopsy at the beginning or after treatment, and consultation with a pathologist; (2)Combined with serious medical diseases: cerebrovascular disease, coronary heart disease, diabetes, high blood pressure, obesity, severe fatty liver, severe hyperlipidemia, renal impairment, adrenal hypofunction; (3)Those with an increased risk of arterial or venous thromboembolism, stroke, and myocardial infarction; including women who are known to have the following conditions: 1)Smoking; 2)Deep vein thrombosis or pulmonary embolism present or in the past; 3)Thrombotic valvular heart disease or thrombotic heart rhythm disease (such as subacute bacterial endocarditis with valvular disease or atrial fibrillation); 4)Inherited or acquired hypercoagulable disease; 5)Headache with focal neurological symptoms; or migraine with or without aura; (4)Undiagnosed abnormal uterine bleeding; (5)Current or past breast cancer or other estrogen or progesterone sensitive cancers, combined with other types of endometrial cancer or other malignant tumors of the reproductive system; (6)There may be multiple cancers and repeated cancer tendencies (breast cancer, ovarian cancer), Lynch syndrome, and Cowden syndrome in the family genetic history; (7)Liver benign or malignant tumors or liver diseases including hepatitis; (8)Pregnancy; (9)Allergic to the active ingredients of this product or any of its excipients;

Design outcomes

Primary

MeasureTime frame
complete remission;

Secondary

MeasureTime frame
abnormal uterine bleeding;clinical pregnancy rate;sex hormones;Tumor index;Metabolic index;Immunohistochemistry;Effect;

Countries

China

Contacts

Public ContactSufang Wu

Shanghai General Hospital

wusufang73@163.com+86 15316954092

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026