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

Phase 3

Completed

• Conditions: Breast Cancer; Vaginal Atrophy
• Interventions: Drug: clino-san vaginal lubricant

• Registration Number: NCT00607295
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-23
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	clino-san vaginal lubricant	Clino-san 2ml vaginal application 3 times per week for 12 weeks
2	clino-san vaginal lubricant	placebo 2ml vaginal application 3 times per week for 12 weeks

Primary Outcome Measures

Name	Time	Method
vaginal dryness score	for 12 weeks

Secondary Outcome Measures

Name	Time	Method
sexual dysfunction	for 12 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of