Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

It is a multi-center, double -blind, placebo -controlled, randomized post-marketing study in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Collaborator: Beijing Bionovo Medicine Development Co., Ltd.
• Treatments: Analgesics

Criteria

Inclusion Criteria:

• Subjects have a diagnosis of endometriosis by laparoscopy within 5 years prior to signing ICF, main complain of dysmenorrhea (or menstrual pain or painful periods) and with VAS score of 4 or above; Endometriosis combined with uterine adenomyosis is included.

• Female between the ages of 18 and 45 years old;

• Regular menstrual period, menstrual cycle falls in the ranging from 28 to 30 days;

• No pregnancy planning during taking study medication; use (or have their partner use) an acceptable method of birth control within the projected duration of the study ;

• Subjects must sign ICF and agree for follow up.

Exclusion Criteria:

• Genital cancer or other malignant tumor;

• Adnexal masses≥5cm;

• Uterine myoma≥3cm;

• Suffering from cardiovascular, hepatic, renal or hematopoietic system disease or mental illness;

• Receiving hormone therapy within 3 months prior to signing ICF;

• Receiving surgical treatment for endometriosis within 3 months prior to signing ICF;

• Subjects have a plan of pregnancy, being pregnant, breast-feeding during recent 3 months.