Trial Outcomes & Findings for Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors (NCT NCT00981305)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

136 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2017-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Lactate-containing Vaginal Lubricant 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)	Placebo 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)
Overall Study STARTED	69	67
Overall Study COMPLETED	50	57
Overall Study NOT COMPLETED	19	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactate-containing Vaginal Lubricant n=50 Participants 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)	Placebo n=57 Participants 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 n=107 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 6.0 • n=5 Participants	49.0 years STANDARD_DEVIATION 5.2 • n=7 Participants	48.8 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Parity	2 pregnancies n=5 Participants	2 pregnancies n=7 Participants	2 pregnancies n=5 Participants
Body mass index	23.1 kg/m^2 STANDARD_DEVIATION 2.4 • n=5 Participants	23.3 kg/m^2 STANDARD_DEVIATION 3.3 • n=7 Participants	23.2 kg/m^2 STANDARD_DEVIATION 2.9 • n=5 Participants
Menopause Yes	35 participants n=5 Participants	41 participants n=7 Participants	76 participants n=5 Participants
Menopause No	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Tamoxifen treatment Yes	33 participants n=5 Participants	40 participants n=7 Participants	73 participants n=5 Participants
Tamoxifen treatment No	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lactate-containing Vaginal Lubricant n=50 Participants 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)	Placebo n=57 Participants 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)
Change of Pain Score of Female Sexual Function Index	1.15 units on a scale Standard Deviation 1.59	1.05 units on a scale Standard Deviation 1.54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lactate-containing Vaginal Lubricant n=50 Participants 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)	Placebo n=57 Participants 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)
Change of a Total and Other Five Domains of Female Sexual Function Index Score Total	2.85 units on a scale Standard Deviation 4.10	3.81 units on a scale Standard Deviation 5.10
Change of a Total and Other Five Domains of Female Sexual Function Index Score Desire	0.19 units on a scale Standard Deviation 1.03	0.45 units on a scale Standard Deviation 0.86
Change of a Total and Other Five Domains of Female Sexual Function Index Score Arousal	0.42 units on a scale Standard Deviation 0.72	0.45 units on a scale Standard Deviation 0.90
Change of a Total and Other Five Domains of Female Sexual Function Index Score Lubrication	0.59 units on a scale Standard Deviation 1.23	0.77 units on a scale Standard Deviation 1.50
Change of a Total and Other Five Domains of Female Sexual Function Index Score Orgasm	0.38 units on a scale Standard Deviation 0.81	0.67 units on a scale Standard Deviation 0.94
Change of a Total and Other Five Domains of Female Sexual Function Index Score Satisfaction	0.11 units on a scale Standard Deviation 0.83	0.43 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Outcome measures
Measure	Lactate-containing Vaginal Lubricant n=50 Participants 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)	Placebo n=57 Participants 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)
Change of Vaginal pH	-0.75 pH Standard Deviation 0.52	-0.02 pH Standard Deviation 0.59

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Lactate-containing Vaginal Lubricant n=50 Participants 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)	Placebo n=57 Participants 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)
Change of Vaginal Maturation Index	4.73 vaginal maturation index Standard Deviation 10.37	1.00 vaginal maturation index Standard Deviation 8.50

Adverse Events

Lactate-containing Vaginal Lubricant

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lactate-containing Vaginal Lubricant n=50 participants at risk 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)	Placebo n=57 participants at risk 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)
Reproductive system and breast disorders Vaginal itching	10.0% 5/50 • 8 weeks	8.8% 5/57 • 8 weeks
Reproductive system and breast disorders Vaginal irritation	0.00% 0/50 • 8 weeks	1.8% 1/57 • 8 weeks
Reproductive system and breast disorders Both	4.0% 2/50 • 8 weeks	1.8% 1/57 • 8 weeks

Additional Information

Myung Jae Jeon

SeoulNUH

Phone: 82-2-2072-1916

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place