Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors

Sexual Dysfunction Clinical Trial

Official title:

Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00981305
• Other study ID #: SNUH 0905-037-281
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 20, 2009
• Last updated: April 18, 2013
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.

Description:

Study scheme

• study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks

• control arm: placebo apply

Outcome measures

• Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk

• vaginal maturation index: at 0 wk and 8 wk

• vaginal pH: at 0 wk and 8 wk

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• breast cancer survivors over 20 years-old

• premenopausal at the time of diagnosis

• treated with operation and chemotherapy

• newly developed dyspareunia after cancer treatment

Exclusion Criteria:

• recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)

• depression or other psychological problems

• active vaginal infection

• evidence of cancer recurrence

• previously use of lactate-containing lubricants

• other chronic diseases which severely disturb the sexual life

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms
• Sexual Dysfunction

Intervention

Drug:
• Lactate-containing vaginal lubricant
vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
• Placebo vaginal lubricant
vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)

Locations

Country	Name	City	State
Korea, Republic of	Myong Jae, Jeon	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medical Research Collaborating Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of FSFI-20 (especially, dyspareunia score) compared with baseline score		8 weeks	No
Secondary	change of vaginal pH compared with baseline		8 weeks	No
Secondary	change of vaginal maturation index compared with baseline		8 weeks	No
Secondary	adverse effect question		8 wks	Yes