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

July 23, 2010 updated by: Seoul National University Hospital

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
vaginal dryness score
Time Frame: for 12 weeks
for 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
sexual dysfunction
Time Frame: for 12 weeks
for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jae Weon Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-OG-07-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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