Trial Outcomes & Findings for Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods) (NCT NCT00651313)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Two 4-day dosing regimens for two consecutive monthy menstrual cycles

Results posted on

2012-02-17

Participant Flow

Clinics and private practice offices; 8/31/07-6/13/08. Maximum patient participation was approx 4 months, including 45 day screening period, a treatment period of approx 8 weeks duration (during which subjects received study drug on a total of 8 days), and a post treatment visit occurring 2 - 3 weeks after Treatment Cycle 2,Visit 5.

Crossover study; Subjects who met study entry criteria after completing screening procedures at Screening Visit returned to study center at least 7 days prior to their expected onset of menses to complete Randomization/Treatment procedures. Abnormal lab values, ECGs or use of prohibited medications were among reasons subjects were excluded.

Participant milestones

Participant milestones
Measure	Active Lidocaine 10% (150mg) vaginal gel	Placebo Placebo vaginal gel
Overall Study STARTED	41	43
Overall Study COMPLETED	35	37
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Lidocaine 10% (150mg) vaginal gel	Placebo Placebo vaginal gel
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	3	1
Overall Study Lost to Follow-up	1	1
Overall Study Adminstrative Discontinuation	2	3

Baseline Characteristics

Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=41 Participants Lidocaine 10% (150mg) vaginal gel	Placebo n=43 Participants Placebo vaginal gel	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=39 Participants	43 Participants n=41 Participants	84 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age Continuous	26.5 years STANDARD_DEVIATION 7.20 • n=39 Participants	27.7 years STANDARD_DEVIATION 6.69 • n=41 Participants	27.1 years STANDARD_DEVIATION 6.92 • n=35 Participants
Sex: Female, Male Female	41 Participants n=39 Participants	43 Participants n=41 Participants	84 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	41 participants n=39 Participants	43 participants n=41 Participants	84 participants n=35 Participants

PRIMARY outcome

Timeframe: Two 4-day dosing regimens for two consecutive monthy menstrual cycles

Population: Time-weighted average pain intensity over the 4 treatment days using the 4 point categorical scale - none (0), mild (1), moderate (2), and severe (3); primary efficacy variable. ITT Analysis Set.

Outcome measures

Outcome measures
Measure	Lidocaine 10% n=70 Participants Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel	Placebo Gel n=70 Participants Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.	0.91 units on a scale Standard Deviation 0.635	0.92 units on a scale Standard Deviation 0.552

PRIMARY outcome

Timeframe: approximately two months, based on onset of menses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 hours following fourth dose in 2 consecutive menstrual cycles

Outcome measures

Outcome data not reported

Adverse Events

Active

Serious events: 0 serious events

Other events: 6 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	Active n=77 participants at risk Lidocaine 10% (150mg) vaginal gel	Placebo n=77 participants at risk Placebo vaginal gel
Nervous system disorders Headache	7.8% 6/77	9.1% 7/77

Additional Information

George W. Creasy, MD Vice President, Clinical Research

Columbia Laboratories, Inc.

Phone: 973-486-8797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60