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

Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods) (Lidocaine 04)

This study has been completed.

Study NCT00651313 Information provided by Columbia Laboratories

First Received on March 28, 2008. Last Updated on June 7, 2011 History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Dysmenorrhea
Interventions:	Drug: Lidocaine Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Active	Lidocaine 10% (150mg) vaginal gel
Placebo	Placebo vaginal gel

Participant Flow: Overall Study

	Active	Placebo
STARTED	41	43
COMPLETED	35	37
NOT COMPLETED	6	6
Adverse Event	0	1
Withdrawal by Subject	3	1
Lost to Follow-up	1	1
Adminstrative Discontinuation	2	3

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Active	Lidocaine 10% (150mg) vaginal gel
Placebo	Placebo vaginal gel

Baseline Measures

	Active	Placebo	Total
Number of Participants [units: participants]	41	43	84
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	41	43	84
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	26.5 ± 7.20	27.7 ± 6.69	27.1 ± 6.92
Gender [units: participants]
Female	41	43	84
Male	0	0	0
Region of Enrollment [units: participants]
United States	41	43	84

Outcome Measures

1. Primary:

The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale. [ Time Frame: Two 4-day dosing regimens for two consecutive monthy menstrual cycles ]

Show Outcome Measure 1

2. Primary:

Treatment-emgergent Adverse Events [ Time Frame: approximately two months, based on onset of menses ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

3. Secondary:

Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing [ Time Frame: 7 hours following fourth dose in 2 consecutive menstrual cycles ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

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

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: George W. Creasy, MD Vice President, Clinical Research
Organization: Columbia Laboratories, Inc.
phone: 973-486-8797
e-mail: gcreasy@columbialabs.com

No publications provided

Responsible Party:	George W. Creasy, MD, FACOG, VP, Clinical Research Columbia Laboratories
ClinicalTrials.gov Identifier:	NCT00651313 History of Changes
Other Study ID Numbers:	COL-1077-04
Study First Received:	March 28, 2008
Results First Received:	June 7, 2011
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration