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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer Survivors; Sexual Dysfunction

Treatments: Drug: Lactate-containing vaginal lubricant; Drug: Placebo vaginal lubricant

Study type: Interventional

Funder types: Other

Identifiers

NCT00981305

SNUH 0905-037-281

Details and patient eligibility

About

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.

Full 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

Enrollment: 136 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

136 participants in 2 patient groups, including a placebo group

Lactate-containing Vaginal Lubricant

Experimental group

Description:

apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Treatment:

Drug: Lactate-containing vaginal lubricant

Placebo

Placebo Comparator group

Description:

apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)

Treatment:

Drug: Placebo vaginal lubricant