Primary Dysmenorrhea Clinical Trial
Official title:
Treatment of Primary Dysmenorrhea With Kanion Capsule (GF) A Randomized, Double-blind, Placebo-controlled, Repeated-Dose and Multi-Center Clinical Phase II Trial
The objectives of this clinical trial are:
- To further study the safety of Kanion Capsule (GF) in primary dysmenorrhea subjects;
- To further evaluate the efficacy of GF in treatment of primary dysmenorrhea.
Status | Completed |
Enrollment | 0 |
Est. completion date | February 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - primary dysmenorrhea Exclusion Criteria: - secondary dysmenorrhea |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia |
Lead Sponsor | Collaborator |
---|---|
Lianyungang Kanion Group, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain reduction | 6 months | ||
Secondary | accompanying symptoms improvement | 6 months |
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