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Comparison of the therapeutic effect of Dinogest and mifepristone on adenomyosis

Comparison of the therapeutic effect of Dinogest and mifepristone on adenomyosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031656
Enrollment
Unknown
Registered
2020-04-06
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-04-13

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

Conditions

Adenomyosis

Interventions

1:dinogest
2:mifepristone
3:GnRHa, dinogest
4:GnRHa, mifepristone

Sponsors

Women's Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female, over 18 years old, the patient agreed to use GnRHa and dinogest mifepristone for treatment and signed the informed consent form; 2. outpatient or ward auxiliary examination such as vaginal B-ultrasound and / or magnetic resonance imaging (MRI) confirmed as adenomyosis requiring temporary surgery, or pathological diagnosis after surgery as adenomyosis; 3. dysmenorrhea with or without menorrhagia; 4. required to keep the uterus Or fertility; 5. within 3 months before drug treatment, none of them received other hormone drugs for adenomyosis; 6. normal or clinically insignificant cervical cytology results (results within 6 months before screening period).

Exclusion criteria

Exclusion criteria: 1. Symptoms such as pelvic pain and vaginal bleeding caused by unknown or non adenomyosis; 2. B Ultrasound diagnosis of endometrial polyps, submucous myomas and other benign lesions or suspicious malignant tumors; 3. receiving other hormone drugs for adenomyosis; 4. using other drugs that interact with the drugs in this study and can not be stopped; 5. patients with serious heart, liver, kidney diseases and adrenal cortex dysfunction; drug allergy or allergic constitution; 6. They have participated in other clinical trials within 3 months; and factors that other personnel think are not suitable to participate in the trial; 7. patients with fertility requirements have poor ovarian reserve function: basic endocrine FSH > 10 IU/L, the sum of follicles in bilateral sinuses is less than 3-5, AMH < 1.1ng/ml.

Design outcomes

Primary

MeasureTime frame
pain score;change of menstrual volume;the level of CA125;the volume of the uterus;liver function;blood lipid level;reproductive hormone level;endometrial thickness;

Countries

China

Contacts

Public ContactXinmei Zhang

Women's Hospital, School of Medicine, Zhejiang University

zxm20130729@163.com+86 18957110072

Outcome results

None listed

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