Efficacy and Safety of Clino-San on Vaginal Dryness of Breast Cancer Patients - Full Text View

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00607295

Purpose

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.
"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.
We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.

Condition	Intervention	Phase
Breast Cancer Vaginal Dryness	Drug: clino-san vaginal lubricant	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

vaginal dryness score [ Time Frame: for 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

sexual dysfunction [ Time Frame: for 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	98
Study Start Date:	December 2007
Study Completion Date:	February 2009
Primary Completion Date:	December 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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607295

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Study Director:

Jae Weon Kim, MD, PhD

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Seoul National University Hospital ( Yookyung Lee )
Study ID Numbers:	SNUH-OG-07-211, No
Study First Received:	February 4, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00607295 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

chemotherapy
hormonal therapy
urogenital atrophy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009