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OpenTrials
Completed

NCT Number: NCT00607295

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Vaginal Atrophy

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clino-san vaginal lubricant

Drug

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

Primary outcomes

  1. vaginal dryness score

    Time frame: for 12 weeks

Secondary outcomes

  1. sexual dysfunction

    Time frame: for 12 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 5, 2008
Registry last updated
Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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