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Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607295
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

Study Description
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Brief Summary:
  1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
  2. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
  3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Breast Cancer Vaginal Atrophy Drug: clino-san vaginal lubricant Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
Study Start Date : December 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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
Placebo Comparator: 2
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


Outcome Measures
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Primary Outcome Measures :
  1. vaginal dryness score [ Time Frame: for 12 weeks ]

Secondary Outcome Measures :
  1. sexual dysfunction [ Time Frame: for 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer patients
  • who are treated with chemotherapy or hormonal therapy
  • who experience no menstruation after the previous therapy
  • who complain of vaginal dryness

Exclusion Criteria:

  • other cancer patients
  • other severe disease
  • poor compliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607295


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Jae Weon Kim, MD, PhD Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yookyung Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00607295    
Other Study ID Numbers: SNUH-OG-07-211
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010
Keywords provided by Seoul National University Hospital:
chemotherapy
hormonal therapy
urogenital atrophy
Additional relevant MeSH terms:
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Breast Neoplasms
Atrophy
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Pathological Conditions, Anatomical