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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00981305
• Collaborator: Medical Research Collaborating Center, Seoul, Korea (Other)
• Enrollment: 136
• Location: 1
• Arms: 2
• Duration (Months): 69.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction; Breast Cancer Survivors	Drug: Lactate-containing vaginal lubricant; Drug: Placebo vaginal lubricant	Phase 3

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactate-containing Vaginal Lubricant 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; 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); Other Names: Clino-san(commercial name in Korea)
Placebo Comparator: Placebo apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)	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); Other Names: placebo

Outcome Measures

Primary Outcome Measures

1. Change of Pain Score of Female Sexual Function Index [Baseline and 8 weeks]

   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.

Secondary Outcome Measures

1. Change of a Total and Other Five Domains of Female Sexual Function Index Score [Baseline and 8 weeks]

   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.

2. Change of Vaginal pH [Baseline and 8 weeks]

3. Change of Vaginal Maturation Index [Baseline and 8 weeks]

   Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Myung Jae, Jeon	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital
• Medical Research Collaborating Center, Seoul, Korea

Investigators

• Principal Investigator: Myung Jae Jeon, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT00981305
• Other Study ID Numbers: SNUH 0905-037-281
• First Posted: Sep 22, 2009
• Last Update Posted: Aug 7, 2017
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Seoul National University Hospital: dyspareunia; breast cancer; sexual dysfunction; vaginal lubricant
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Lactate-containing Vaginal Lubricant	Placebo
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)
Period Title: Overall Study
STARTED	69	67
COMPLETED	50	57
NOT COMPLETED	19	10

Baseline Characteristics

Arm/Group Title	Lactate-containing Vaginal Lubricant	Placebo	Total
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)	Total of all reporting groups
Overall Participants	50	57	107
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.6 (6.0)	49.0 (5.2)	48.8 (5.6)
Sex: Female, Male (Count of Participants)
Female	50 100%	57 100%	107 100%
Male	0 0%	0 0%	0 0%
Parity (pregnancies) [Median (Full Range) ]
Median (Full Range) [pregnancies]	2	2	2
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.1 (2.4)	23.3 (3.3)	23.2 (2.9)
Menopause (participants) [Number]
Yes	35 70%	41 71.9%	76 71%
No	15 30%	16 28.1%	31 29%
Tamoxifen treatment (participants) [Number]
Yes	33 66%	40 70.2%	73 68.2%
No	17 34%	17 29.8%	34 31.8%

Outcome Measures

1. Primary Outcome

Title	Change of Pain Score of Female Sexual Function Index
Description	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.
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lactate-containing Vaginal Lubricant	Placebo
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)
Measure Participants	50	57
Mean (Standard Deviation) [units on a scale]	1.15 (1.59)	1.05 (1.54)

2. Secondary Outcome

Title	Change of a Total and Other Five Domains of Female Sexual Function Index Score
Description	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.
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lactate-containing Vaginal Lubricant	Placebo
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)
Measure Participants	50	57
Total	2.85 (4.10)	3.81 (5.10)
Desire	0.19 (1.03)	0.45 (0.86)
Arousal	0.42 (0.72)	0.45 (0.90)
Lubrication	0.59 (1.23)	0.77 (1.50)
Orgasm	0.38 (0.81)	0.67 (0.94)
Satisfaction	0.11 (0.83)	0.43 (1.06)

3. Secondary Outcome

Title	Change of Vaginal pH
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lactate-containing Vaginal Lubricant	Placebo
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)
Measure Participants	50	57
Mean (Standard Deviation) [pH]	-0.75 (0.52)	-0.02 (0.59)

4. Secondary Outcome

Title	Change of Vaginal Maturation Index
Description	Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lactate-containing Vaginal Lubricant	Placebo
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)	apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)
Measure Participants	50	57
Mean (Standard Deviation) [vaginal maturation index]	4.73 (10.37)	1.00 (8.50)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Lactate-containing Vaginal Lubricant		Placebo
Arm/Group Description	apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) 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)		apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per 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)
All Cause Mortality
	Lactate-containing Vaginal Lubricant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lactate-containing Vaginal Lubricant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Lactate-containing Vaginal Lubricant		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/50 (14%)		7/57 (12.3%)
Reproductive system and breast disorders
Vaginal itching	5/50 (10%)		5/57 (8.8%)
Vaginal irritation	0/50 (0%)		1/57 (1.8%)
Both	2/50 (4%)		1/57 (1.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.