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 Atrophy	Drug: clino-san vaginal lubricant	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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
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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders 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

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 by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee YK, Chung HH, Kim JW, Park NH, Song YS, Kang SB. Vaginal pH-balanced gel for the control of atrophic vaginitis among breast cancer survivors: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):922-7.

Responsible Party:	Yookyung Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00607295 History of Changes
Other Study ID Numbers:	SNUH-OG-07-211
Study First Received:	February 4, 2008
Last Updated:	July 23, 2010
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:

Breast Neoplasms
Atrophy
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 12, 2012