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| Sponsors and Collaborators: |
Seoul National University Hospital None |
| Information provided by: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00607295 |
Purpose
| Condition | Intervention | Phase |
|
Breast Cancer Vaginal Dryness |
Drug: clino-san vaginal lubricant |
Phase III |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Prospective Randomized Study on Efficacy and Safety of Clino-San® in the Management of Vaginal Dryness in Breast Cancer Patients |
| Estimated Enrollment: | 98 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Clino-san 2ml vaginal application 3 times per week for 12 weeks
|
Drug: clino-san vaginal lubricant
Clino-san 2ml vaginal application 3 times per week for 12 weeks
|
|
2: Placebo Comparator
placebo 2ml vaginal application 3 times per week for 12 weeks
|
Drug: clino-san vaginal lubricant
Clino-san 2ml vaginal application 3 times per week for 12 weeks
|
Eligibility
| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yookyung Lee, MD | 82-2-2072-2821 | yookyung@yahoo.com |
| Korea, Republic of | |||||
| Seoul National University Hospital | Recruiting | ||||
| Seoul, Korea, Republic of, 110-744 | |||||
| Contact: Yoo Kyung Lee, MD 82-2-2072-2821 yookyung@yahoo.com | |||||
| Principal Investigator: Jae Weon Kim, MD, PhD | |||||
| Seoul National University Hospital |
| None |
| Study Director: | Jae Weon Kim, MD, PhD | Seoul National University Hospital |
More Information
| Responsible Party: | Seoul National University Hospital ( Yookyung Lee ) |
| Study ID Numbers: | SNUH-OG-07-211, No |
| First Received: | February 4, 2008 |
| Last Updated: | February 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00607295 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
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