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

NCT ID: NCT00981305

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-07-31

Brief 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.

Detailed 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

Conditions

Sexual Dysfunction; Breast Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lactate-containing Vaginal Lubricant

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

Group Type: EXPERIMENTAL

Lactate-containing vaginal lubricant

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo vaginal lubricant

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

Clino-san(commercial name in Korea); placebo

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Collaborating Center, Seoul, Korea

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myung Jae Jeon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Myung Jae, Jeon

Seoul, , South Korea

Countries

South Korea

References

Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.

Reference Type: DERIVED

PMID: 28383379 (View on PubMed)

Other Identifiers

SNUH 0905-037-281

Identifier Type: -

Identifier Source: org_study_id