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

NCT00981305 | Completed Phase 3 Results DMC

• 1 other identifier: SNUH 0905-037-281
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Breast Cancer Survivors

Keywords

dyspareunia; breast cancer; sexual dysfunction; vaginal lubricant

Outcome Measures

Primary Outcomes (1)

• Change of Pain Score of Female Sexual Function Index

  The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.

  Baseline and 8 weeks

Secondary Outcomes (3)

• Change of a Total and Other Five Domains of Female Sexual Function Index Score

  Baseline and 8 weeks

• Change of Vaginal pH

  Baseline and 8 weeks

• Change of Vaginal Maturation Index

  Baseline and 8 weeks

Study Arms (2)

Lactate-containing Vaginal Lubricant

EXPERIMENTAL

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

Drug: Lactate-containing vaginal lubricant

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo vaginal lubricant

Interventions

Lactate-containing vaginal lubricant 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)

Also known as: Clino-san(commercial name in Korea)

Lactate-containing Vaginal Lubricant

Placebo vaginal lubricant 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)

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• breast cancer survivors over 20 years-old
• premenopausal at the time of diagnosis
• treated with operation and chemotherapy
• newly developed dyspareunia after cancer treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Medical Research Collaborating Center, Seoul, Korea: collaborator

Study Sites (1)

Myung Jae, Jeon

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28383379 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Dyspareunia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Myung Jae Jeon
• Organization: SeoulNUH

jeonmj@snu.ac.kr

82-2-2072-1916

Study Officials

• Myung Jae Jeon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 7, 2017
• Results First Posted: January 26, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)