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Application of etopregnene subcutaneous implant in long-term postoperative management of endometriosis

Application of etopregnene subcutaneous implant in long-term postoperative management of endometriosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058821
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-04-10
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Endometriosis

Interventions

Observation group:Etopregnene subcutaneous implant
Control group:Mirena

Sponsors

Jiaxing Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Postoperative patients with endometriosis confirmed by laparoscopic surgery; 2. The visual analogue scale (VAS) of endometriosis with dysmenorrhea before operation >0; 3. Women aged 18-55 (premenopausal) who currently have no fertility requirements and require contraception; 4. Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe anemia; 2. Undiagnosed abnormal vaginal bleeding or endometrial lesions; 3. Genital malformations such as mediastinal uterus, double uterus, etc. Uterine cavity 9.5cm; 4. Hormone dependent benign gynecological diseases such as adenomyosis and hysteromyoma; 5. Patients with severe heart, liver and kidney diseases and adrenocortical insufficiency; 6. Combined with malignant tumors (including reproductive system and other systems); The laboratory test value indicates that it has abnormal clinical significance; 7. Allergic constitution or previous allergy to multiple drugs, or allergic to active ingredients or any excipients in the study drug; 8. Suffering from any disease or symptom that may cause the study drug to change absorption, excessive accumulation, affect metabolism or change the mode of excretion; 9. Suffering from clinically significant depression in the current or recent year; 10. Taking analgesics regularly due to other basic diseases; 11. Patients who have participated in other clinical trials within 3 months before screening or who are considered unsuitable by other researchers to participate in this study; 12. The laboratory test value indicates that it has abnormal clinical significance.

Design outcomes

Primary

MeasureTime frame
VAS score for dysmenorrhea;

Secondary

MeasureTime frame
Recurrence rate of endometrioid cyst of ovary (%);PBAC;Sugar antigen CA125;

Countries

China

Contacts

Public ContactXiaoji Cai

Jiaxing Maternal and Child Health Hospital

18704634467@163.com+86 13867364164

Outcome results

None listed

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