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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Vaginal Atrophy

Treatments: Drug: clino-san vaginal lubricant

Study type: Interventional

Funder types: Other

Identifiers

NCT00607295

SNUH-OG-07-211

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

98 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: clino-san vaginal lubricant

2

Placebo Comparator group

Description:

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

Treatment:

Drug: clino-san vaginal lubricant