Know Cancer

or
forgot password

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


Phase 3
20 Years
N/A
Not Enrolling
Female
Breast Cancer, Vaginal Atrophy

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

vaginal dryness score

Outcome Time Frame:

for 12 weeks

Safety Issue:

Yes

Principal Investigator

Jae Weon Kim, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Seoul National University Hospital

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

SNUH-OG-07-211

NCT ID:

NCT00607295

Start Date:

December 2007

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • Vaginal Atrophy
  • chemotherapy
  • hormonal therapy
  • urogenital atrophy
  • Breast Neoplasms
  • Atrophy

Name

Location