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

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

April 8, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00607295 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Randomized Study on Efficacy and Safety of Clino-San® in the Management of Vaginal Dryness in Breast Cancer Patients

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer
Vaginal Dryness

Intervention ^ICMJE

Drug: clino-san vaginal lubricant

Study Arms / Comparison Groups

Experimental: Clino-san 2ml vaginal application 3 times per week for 12 weeks
Placebo Comparator: placebo 2ml vaginal application 3 times per week for 12 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00607295

Responsible Party

Yookyung Lee, Seoul National University Hospital

Study ID Numbers ^ICMJE

SNUH-OG-07-211, No

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jae Weon Kim, MD, PhD

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP