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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607295
• Other study ID #: SNUH-OG-07-211
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: July 23, 2010
• Start date: December 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Breast Cancer
• Breast Neoplasms
• Vaginal Atrophy

Intervention

Drug:
• clino-san vaginal lubricant
Clino-san 2ml vaginal application 3 times per week for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaginal dryness score		for 12 weeks
Secondary	sexual dysfunction		for 12 weeks