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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00981305
Other study ID # SNUH 0905-037-281
Secondary ID
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


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
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