Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Sponsor
Lumara Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00590590
Collaborator
(none)
105
48
3
21
2.2
0.1
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Jul 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 3 (Placebo)
|
Drug: placebo
semi solid, twice weekly for 4 months
|
| Experimental: 1 (Lidocaine)
|
Drug: lidocaine
semi solid, twice weekly for 4 months
|
| Experimental: 2 (Lidocaine/Diphenhydramine)
|
Drug: Lidocaine/Diphenhydramine
semi solid, twice weekly, 4 months
|
Outcome Measures
Primary Outcome Measures
- Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) [12 weeks]
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
Secondary Outcome Measures
- Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) [Baseline -12 Weeks]
0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
- 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] [12 Weeks]
- 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] [12 weeks]
- 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] [12 Weeks]
- 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] [12 Weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must have sought doctor's care for this condition.
-
Patients must be having menstrual cycles.
Exclusion Criteria:
-
Patients must not have any vaginal infections.
-
Patients must not be pregnant or nursing.
-
Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montgomery Women's Health Associates, P.C. | Montgomery | Alabama | United States | 36116 |
| 2 | Star W. Research | Chandler | Arizona | United States | 85225 |
| 3 | Precision Trials LLC | Phoenix | Arizona | United States | 85032 |
| 4 | Searcy Medical Center | Searcy | Arkansas | United States | 72143 |
| 5 | Universal Biopharma Research Institute, Inc. | Dinuba | California | United States | 93618 |
| 6 | San Diego Clinical Research Center | San Diego | California | United States | 92103 |
| 7 | Red Rocks OB/GYN | Lakewood | Colorado | United States | 80228 |
| 8 | Taylor Associates/Gynecology | Farmington | Connecticut | United States | |
| 9 | Women's Medical Research Group, LLC | Clearwater | Florida | United States | 33759 |
| 10 | Clinical Research of Tampa Bay | Hudson | Florida | United States | 34667 |
| 11 | Innovative Research of W. Florida | Largo | Florida | United States | 33770 |
| 12 | Women's Health Care Specialists, PC | Paw Paw | Florida | United States | 49079 |
| 13 | Tampa Bay Women's Healthcare Alliance, LLP | Tampa | Florida | United States | 33607 |
| 14 | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | United States | 33409 |
| 15 | Atlanta Women's Research Institute, Inc. | Atlanta | Georgia | United States | 30342 |
| 16 | Atlanta North Gynecology, PC | Roswell | Georgia | United States | 30075 |
| 17 | Womans Clinic | Boise | Idaho | United States | 83712 |
| 18 | Rosemark Women Care Specialists | Idaho Falls | Idaho | United States | 83404 |
| 19 | Women's Health Practice, LLC | Champaign | Illinois | United States | 61820 |
| 20 | Northern Indiana Womens Health Research | South Bend | Indiana | United States | 46601 |
| 21 | Female Pelvic Medicine and Urogynecology | Grand Rapids | Michigan | United States | 49506 |
| 22 | Boro Park ObGyn | Brooklyn | New York | United States | 11219 |
| 23 | Eastern Carolina Womens Center | New Bern | North Carolina | United States | 28562 |
| 24 | Lyndhurst Clinical Research | Winston Salem | North Carolina | United States | 27103 |
| 25 | Winston-Salem Woman Care, PA | Winston-Salem | North Carolina | United States | 27103 |
| 26 | Holzer Clinic | Gallipolis | Ohio | United States | 45631 |
| 27 | HWC Women's Research Center | Miamisburg | Ohio | United States | 45342 |
| 28 | Advanced Clinical Research | Medford | Oregon | United States | 97504 |
| 29 | Lehigh Valley Health Network | Allentown | Pennsylvania | United States | 18105 |
| 30 | Advanced Clinical Concepts | West Reading | Pennsylvania | United States | 19611 |
| 31 | Hillcrest Clinical Research, LLC | Simpsonville | South Carolina | United States | 29681 |
| 32 | Southeastern Clinical Research | Chattanooga | Tennessee | United States | 37403 |
| 33 | The Jackson Clinic, PA | Jackson | Tennessee | United States | 38305 |
| 34 | Women's Care Center, PLC | Memphis | Tennessee | United States | 38119 |
| 35 | Gynecology and Obstetrics, P.C. | Memphis | Tennessee | United States | 38120 |
| 36 | Professional Quality Research/Women Partners | Austin | Texas | United States | 78705 |
| 37 | Advanced Research Associates | Corpus Christi | Texas | United States | 78414 |
| 38 | Woman's Hospital of Texas | Houston | Texas | United States | 77054 |
| 39 | Bexar Clinical Trials | Irving | Texas | United States | 75061 |
| 40 | Salt Lake Research | Salt Lake City | Utah | United States | 84107 |
| 41 | Salt Lake Women's Center | Sandy | Utah | United States | 84070 |
| 42 | Gain Medical Centre | Coquitlam | British Columbia | Canada | V3K 3P4 |
| 43 | Stephen Kaye, MD | North Vancouver | British Columbia | Canada | V7M 2H5 |
| 44 | Southern Healthcare Centre | White Rock | British Columbia | Canada | V4B 5C9 |
| 45 | Common Wealth Medical Clinic | Mt. Pearl | Newfoundland and Labrador | Canada | A1N 1W7 |
| 46 | The Ottawa Hospital-Soundcare Medical Centre | Ottawa | Ontario | Canada | K1V 0Y3 |
| 47 | Royal Health Care Centre | Toronto | Ontario | Canada | M5H 3P5 |
| 48 | Windsor Metropolitan Hospital | Windsor | Ontario | Canada | N8X 3V6 |
Sponsors and Collaborators
- Lumara Health, Inc.
Investigators
- Study Director: Jim Joffrion, Lumara Health, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT00590590
Other Study ID Numbers:
- LDC-201-601-669020
First Posted:
Jan 10, 2008
Last Update Posted:
Mar 2, 2012
Last Verified:
Feb 1, 2012
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009. |
|---|---|
| Pre-assignment Detail | Participants will undergo a screening period of two weeks prior to study assignment. |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Period Title: Overall Study | |||
| STARTED | 39 | 39 | 27 |
| COMPLETED | 32 | 33 | 21 |
| NOT COMPLETED | 7 | 6 | 6 |
Baseline Characteristics
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months | Total of all reporting groups |
| Overall Participants | 39 | 39 | 27 | 105 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
39
100%
|
39
100%
|
27
100%
|
105
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
30
(7.4)
|
32
(9.0)
|
32
(9.5)
|
31
(8.5)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
39
100%
|
39
100%
|
27
100%
|
105
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
36
92.3%
|
39
100%
|
25
92.6%
|
100
95.2%
|
| Canada |
3
7.7%
|
0
0%
|
2
7.4%
|
5
4.8%
|
Outcome Measures
| Title | Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) |
|---|---|
| Description | 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 |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Measure Participants | 39 | 39 | 27 |
| Mean (Standard Error) [scores on a scale] |
1.8
(0.12)
|
1.8
(0.12)
|
1.7
(0.14)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Lidocaine |
|---|---|---|
| Comments | Ha: Drug 1 < Drug 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Placebo |
|---|---|---|
| Comments | Ha: Drug 1 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Placebo |
|---|---|---|
| Comments | Ha: Drug 2 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) |
|---|---|
| Description | 0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse |
| Time Frame | Baseline -12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Measure Participants | 39 | 39 | 27 |
| Mean (Standard Error) [Score] |
-0.6
(0.15)
|
-0.4
(0.13)
|
-0.7
(0.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Lidocaine |
|---|---|---|
| Comments | Ha: Drug 1 < Drug 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.2 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Placebo |
|---|---|---|
| Comments | Ha: Drug 1 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Placebo |
|---|---|---|
| Comments | Ha: Drug 2 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.3 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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] |
|---|---|
| Description | |
| Time Frame | 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Measure Participants | 39 | 39 | 27 |
| Mean (Standard Error) [Score] |
-9.9
(3.48)
|
-3.8
(4.46)
|
-14.6
(4.56)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Lidocaine |
|---|---|---|
| Comments | Ha: Drug 1 < Drug 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.1 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Placebo |
|---|---|---|
| Comments | Ha: Drug 1 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.7 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Placebo |
|---|---|---|
| Comments | Ha: Drug 2 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 10.8 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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] |
|---|---|
| Description | |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Measure Participants | 39 | 39 | 27 |
| Mean (Standard Error) [Score] |
-10.3
(5.71)
|
-19.6
(4.42)
|
-19.3
(6.55)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Lidocaine |
|---|---|---|
| Comments | Ha: Drug 1 < Drug 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 9.3 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Placebo |
|---|---|---|
| Comments | Ha: Drug 1 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 9 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Placebo |
|---|---|---|
| Comments | Ha: Drug 2 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.3 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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] |
|---|---|
| Description | |
| Time Frame | 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Measure Participants | 39 | 39 | 27 |
| Mean (Standard Error) [Score] |
-10.4
(4.31)
|
-5.3
(4.47)
|
-16.3
(4.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Lidocaine |
|---|---|---|
| Comments | Ha: Drug 1 < Drug 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.1 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Placebo |
|---|---|---|
| Comments | Ha: Drug 1 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.9 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Placebo |
|---|---|---|
| Comments | Ha: Drug 2 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 11 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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] |
|---|---|
| Description | |
| Time Frame | 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo |
|---|---|---|---|
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months |
| Measure Participants | 39 | 39 | 27 |
| Mean (Standard Error) [Score] |
-3.0
(0.70)
|
-1.7
(0.67)
|
-2.4
(0.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Lidocaine |
|---|---|---|
| Comments | Ha: Drug 1 < Drug 2 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.3 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine/Diphenhydramine (Combination), Placebo |
|---|---|---|
| Comments | Ha: Drug 1 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.6 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Placebo |
|---|---|---|
| Comments | Ha: Drug 2 < Placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.7 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 16 weeks for each subject | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse Events were collected and assessed during each study visit during the 12 week treatment period and 4 week follow-up period. | |||||
| Arm/Group Title | Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo | |||
| Arm/Group Description | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | Lidocaine administered twice weekly for 4 months | Placebo administered twice weekly for 4 months | |||
All Cause Mortality |
||||||
| Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/39 (0%) | 0/39 (0%) | 0/27 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Lidocaine/Diphenhydramine (Combination) | Lidocaine | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/39 (76.9%) | 30/39 (76.9%) | 23/27 (85.2%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 2/39 (5.1%) | 2/39 (5.1%) | 2/27 (7.4%) | |||
| Constipation | 3/39 (7.7%) | 1/39 (2.6%) | 0/27 (0%) | |||
| Dyspepsia | 1/39 (2.6%) | 3/39 (7.7%) | 0/27 (0%) | |||
| General disorders | ||||||
| Pain | 3/39 (7.7%) | 0/39 (0%) | 2/27 (7.4%) | |||
| Pyrexia | 0/39 (0%) | 3/39 (7.7%) | 0/27 (0%) | |||
| Immune system disorders | ||||||
| Multiple allergies | 2/39 (5.1%) | 0/39 (0%) | 2/27 (7.4%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 7/39 (17.9%) | 4/39 (10.3%) | 6/27 (22.2%) | |||
| Fungal infection | 3/39 (7.7%) | 4/39 (10.3%) | 2/27 (7.4%) | |||
| Vaginal candidiasis | 2/39 (5.1%) | 4/39 (10.3%) | 2/27 (7.4%) | |||
| Urinary tract infection | 1/39 (2.6%) | 3/39 (7.7%) | 1/27 (3.7%) | |||
| Upper respiratory tract infection | 1/39 (2.6%) | 1/39 (2.6%) | 2/27 (7.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 3/39 (7.7%) | 1/39 (2.6%) | 0/27 (0%) | |||
| Nervous system disorders | ||||||
| Headache | 8/39 (20.5%) | 5/39 (12.8%) | 3/27 (11.1%) | |||
| Reproductive system and breast disorders | ||||||
| Dysmenorrhoea | 3/39 (7.7%) | 4/39 (10.3%) | 4/27 (14.8%) | |||
| Vulvovaginal burning sensation | 4/39 (10.3%) | 3/39 (7.7%) | 4/27 (14.8%) | |||
| Vulvovaginal discomfort | 3/39 (7.7%) | 4/39 (10.3%) | 1/27 (3.7%) | |||
| Vulvovaginal pruritus | 1/39 (2.6%) | 5/39 (12.8%) | 1/27 (3.7%) | |||
| Vaginal Discharge | 3/39 (7.7%) | 2/39 (5.1%) | 1/27 (3.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Nasal congestion | 3/39 (7.7%) | 0/39 (0%) | 0/27 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 3/39 (7.7%) | 2/39 (5.1%) | 0/27 (0%) | |||
Limitations/Caveats
The study was discontinued following enrollment of 106 of the planned 140 participants due to slow recruitment.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Jim Joffrion, Sr. Director, Clinical Affairs |
|---|---|
| Organization | KV Pharmaceutical |
| Phone | 314-645-6600 |
| jjoffrion@kvph.com |
Responsible Party:
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT00590590
Other Study ID Numbers:
- LDC-201-601-669020
First Posted:
Jan 10, 2008
Last Update Posted:
Mar 2, 2012
Last Verified:
Feb 1, 2012