Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients
Phase 3
Completed
- Conditions
- Breast CancerVaginal 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
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