Dysmenorrhea Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Post-marketing Study to Assess the Treatment Effect of Sanjie Analgesic Capsule in Treating Endometriosis - Associated Pain
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing ChaoYang Hospital | Beijing | Beijing |
China | Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
China | The General Hospital of People's Liberation Army | Beijing | Beijing |
China | The First Hospital of Hunan University of chinese Medicine | Changsha | Hunan |
China | The Maternal and Child Health Hospital of Hunan Province | Changsha | Hunan |
China | Guangxing Hospital Of Zhejiang Chinese Medicine University | Hangzhou | Zhejiang |
China | Women's Hospital School Of Medicine Zhejiang University | Hangzhou | Zhejiang |
China | Jinan municipal hospital of Traditional Chinese Medicine | Jinan | Shandong |
China | The Second Hospital of Shandong University of Traditional Chinese Medicine | Jinan | Shandong |
China | Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai |
China | Shengjing Hospital of China Medical University | Shen yang | Liaoning |
China | Hubei Provincal Hospital of TCM | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Kanion Pharmaceutical Co., Ltd | Beijing Bionovo Medicine Development Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | dysmenorrhea | Baseline, 1,2,3,4 menstrual cycle | No | |
Secondary | change of Symptom (CPP Dyspareunia Defecate-pain Anal-bulge ) | baseline,1,2,3,4 menstrual cycle | No | |
Secondary | change of Signs(Pelvic-tenderness Tubercle ) | baseline,1,2,3,4 menstrual cycle | No | |
Secondary | change of Menstrual cycle and quantity | baseline,1,2,3,4 menstrual cycle | No | |
Secondary | change of serum CA125 | baseline,3,4 menstrual cycle | No | |
Secondary | the size of uterus and endometriosis cyst | baseline,3,4 menstrual cycle | No | |
Secondary | change of serum endocrinological hormone | the content of FSH, LH, E2, PRL, P, T | baseline,3,4 menstrual cycle | No |
Secondary | change of SF-36 score | Baseline,3 menstrual cycle | No | |
Secondary | Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests | Baseline,3 menstrual cycle | Yes | |
Secondary | Safety assessments will be based on adverse event reports | 1,2,3 menstrual cycle | Yes |
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