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

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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

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

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 ]

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

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

Contacts


Contact: Yookyung Lee, MD	82-2-2072-2821	yookyung@yahoo.com

Locations


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

Sponsors and Collaborators

Seoul National University Hospital

None

Investigators


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)

Keywords provided by Seoul National University Hospital:

chemotherapy

hormonal therapy

urogenital atrophy

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Atrophy

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on August 21, 2008

Sponsors and Collaborators:	Seoul National University Hospital None
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00607295