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

Primary Purpose

Breast Cancer, Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
clino-san vaginal lubricant
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring chemotherapy, hormonal therapy, urogenital atrophy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Clino-san 2ml vaginal application 3 times per week for 12 weeks

placebo 2ml vaginal application 3 times per week for 12 weeks

Outcomes

Primary Outcome Measures

vaginal dryness score

Secondary Outcome Measures

sexual dysfunction

Full Information

First Posted
February 4, 2008
Last Updated
July 23, 2010
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00607295
Brief Title
Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients
Official Title
Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Vaginal Atrophy
Keywords
chemotherapy, hormonal therapy, urogenital atrophy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Clino-san 2ml vaginal application 3 times per week for 12 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo 2ml vaginal application 3 times per week for 12 weeks
Intervention Type
Drug
Intervention Name(s)
clino-san vaginal lubricant
Intervention Description
Clino-san 2ml vaginal application 3 times per week for 12 weeks
Primary Outcome Measure Information:
Title
vaginal dryness score
Time Frame
for 12 weeks
Secondary Outcome Measure Information:
Title
sexual dysfunction
Time Frame
for 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Weon Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21422866
Citation
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):922-927. doi: 10.1097/AOG.0b013e3182118790.
Results Reference
derived

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

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