Trial Outcomes & Findings for Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort (NCT NCT00590590)

Last Updated: 2012-03-02

Results Overview

The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-03-02

Participant Flow

Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009.

Participants will undergo a screening period of two weeks prior to study assignment.

Participant milestones

Participant milestones
Measure	Lidocaine/Diphenhydramine (Combination) Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine Lidocaine administered twice weekly for 4 months	Placebo Placebo administered twice weekly for 4 months
Overall Study STARTED	39	39	27
Overall Study COMPLETED	32	33	21
Overall Study NOT COMPLETED	7	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine/Diphenhydramine (Combination) Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine Lidocaine administered twice weekly for 4 months	Placebo Placebo administered twice weekly for 4 months
Overall Study Lack of Efficacy	1	2	0
Overall Study Adverse Event	1	0	0
Overall Study Protocol Violation	0	0	2
Overall Study Lost to Follow-up	4	1	2
Overall Study Withdrawal by Subject	0	1	1
Overall Study Did not complete due to study closure	1	1	1
Overall Study Did not complete study	0	1	0

Baseline Characteristics

Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=93 Participants	39 Participants n=4 Participants	27 Participants n=27 Participants	105 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	30 years STANDARD_DEVIATION 7.4 • n=93 Participants	32 years STANDARD_DEVIATION 9.0 • n=4 Participants	32 years STANDARD_DEVIATION 9.5 • n=27 Participants	31 years STANDARD_DEVIATION 8.5 • n=483 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	39 Participants n=4 Participants	27 Participants n=27 Participants	105 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	36 participants n=93 Participants	39 participants n=4 Participants	25 participants n=27 Participants	100 participants n=483 Participants
Region of Enrollment Canada	3 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants	5 participants n=483 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)	1.8 scores on a scale Standard Error 0.12	1.8 scores on a scale Standard Error 0.12	1.7 scores on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline -12 Weeks

0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse

Outcome measures

Outcome measures
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months
Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)	-0.6 Score Standard Error 0.15	-0.4 Score Standard Error 0.13	-0.7 Score Standard Error 0.15

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months
Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]	-9.9 Score Standard Error 3.48	-3.8 Score Standard Error 4.46	-14.6 Score Standard Error 4.56

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months
Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]	-10.3 Score Standard Error 5.71	-19.6 Score Standard Error 4.42	-19.3 Score Standard Error 6.55

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months
Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]	-10.4 Score Standard Error 4.31	-5.3 Score Standard Error 4.47	-16.3 Score Standard Error 4.22

SECONDARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure	Lidocaine/Diphenhydramine (Combination) n=39 Participants Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 Participants Lidocaine administered twice weekly for 4 months	Placebo n=27 Participants Placebo administered twice weekly for 4 months
Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]	-3.0 Score Standard Error 0.70	-1.7 Score Standard Error 0.67	-2.4 Score Standard Error 0.75

Adverse Events

Lidocaine/Diphenhydramine (Combination)

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jim Joffrion, Sr. Director, Clinical Affairs

KV Pharmaceutical

Phone: 314-645-6600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall not publish, or seek to publish, either in whole or in part, any results of the Clinical Investigation without the written consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Lidocaine/Diphenhydramine (Combination) n=39 participants at risk Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months	Lidocaine n=39 participants at risk Lidocaine administered twice weekly for 4 months	Placebo n=27 participants at risk Placebo administered twice weekly for 4 months
Infections and infestations Nasopharyngitis	17.9% 7/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	10.3% 4/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	22.2% 6/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Infections and infestations Fungal infection	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	10.3% 4/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.4% 2/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Infections and infestations Vaginal candidiasis	5.1% 2/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	10.3% 4/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.4% 2/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Infections and infestations Urinary tract infection	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	3.7% 1/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Infections and infestations Upper respiratory tract infection	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.4% 2/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Reproductive system and breast disorders Dysmenorrhoea	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	10.3% 4/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	14.8% 4/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Reproductive system and breast disorders Vulvovaginal burning sensation	10.3% 4/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	14.8% 4/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Reproductive system and breast disorders Vulvovaginal discomfort	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	10.3% 4/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	3.7% 1/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Reproductive system and breast disorders Vulvovaginal pruritus	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	12.8% 5/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	3.7% 1/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Reproductive system and breast disorders Vaginal Discharge	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	5.1% 2/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	3.7% 1/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Gastrointestinal disorders Nausea	5.1% 2/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	5.1% 2/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.4% 2/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Gastrointestinal disorders Constipation	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Gastrointestinal disorders Dyspepsia	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Nervous system disorders Headache	20.5% 8/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	12.8% 5/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	11.1% 3/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
General disorders Pain	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.4% 2/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
General disorders Pyrexia	0.00% 0/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Musculoskeletal and connective tissue disorders Back pain	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	2.6% 1/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Skin and subcutaneous tissue disorders Pruritus	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	5.1% 2/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Immune system disorders Multiple allergies	5.1% 2/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	7.4% 2/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 3/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/39 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.	0.00% 0/27 • 16 weeks for each subject Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period.