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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00607295
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Duration (Months): 14.1
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Vaginal Atrophy	Drug: clino-san vaginal lubricant	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. vaginal dryness score [for 12 weeks]

Secondary Outcome Measures

1. sexual dysfunction [for 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00607295
• Other Study ID Numbers: SNUH-OG-07-211
• First Posted: Feb 5, 2008
• Last Update Posted: Jul 27, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: chemotherapy; hormonal therapy; urogenital atrophy
• Additional relevant MeSH terms: Breast Neoplasms; Atrophy

Study Results

No Results Posted as of Jul 27, 2010