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Trial record 90 of 449 for:    diphenhydramine

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

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ClinicalTrials.gov Identifier: NCT00590590
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : February 9, 2011
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vulvodynia
Interventions Drug: Lidocaine/Diphenhydramine
Drug: lidocaine
Drug: placebo
Enrollment 105
Recruitment Details Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009.
Pre-assignment Details Participants will undergo a screening period of two weeks prior to study assignment.
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Reason Not Completed
Lack of Efficacy             1             2             0
Adverse Event             1             0             0
Protocol Violation             0             0             2
Lost to Follow-up             4             1             2
Withdrawal by Subject             0             1             1
Did not complete due to study closure             1             1             1
Did not complete study             0             1             0
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo Total
Hide 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 Number of Baseline Participants 39 39 27 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 27 participants 105 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
 100.0%
39
 100.0%
27
 100.0%
105
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 39 participants 27 participants 105 participants
30  (7.4) 32  (9.0) 32  (9.5) 31  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 27 participants 105 participants
Female
39
 100.0%
39
 100.0%
27
 100.0%
105
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 27 participants 105 participants
United States 36 39 25 100
Canada 3 0 2 5
1.Primary Outcome
Title Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Overall Number of Participants Analyzed 39 39 27
Mean (Standard Error)
Unit of Measure: scores on a scale
1.8  (0.12) 1.8  (0.12) 1.7  (0.14)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine, Placebo
Comments Ha: Drug 2 < Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)
Hide Description 0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
Time Frame Baseline -12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Overall Number of Participants Analyzed 39 39 27
Mean (Standard Error)
Unit of Measure: Score
-0.6  (0.15) -0.4  (0.13) -0.7  (0.15)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine, Placebo
Comments Ha: Drug 2 < Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Estimation Comments [Not Specified]
3.Secondary Outcome
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]
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Overall Number of Participants Analyzed 39 39 27
Mean (Standard Error)
Unit of Measure: Score
-9.9  (3.48) -3.8  (4.46) -14.6  (4.56)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine, Placebo
Comments Ha: Drug 2 < Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.8
Estimation Comments [Not Specified]
4.Secondary Outcome
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]
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Overall Number of Participants Analyzed 39 39 27
Mean (Standard Error)
Unit of Measure: Score
-10.3  (5.71) -19.6  (4.42) -19.3  (6.55)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine, Placebo
Comments Ha: Drug 2 < Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Estimation Comments [Not Specified]
5.Secondary Outcome
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]
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Overall Number of Participants Analyzed 39 39 27
Mean (Standard Error)
Unit of Measure: Score
-10.4  (4.31) -5.3  (4.47) -16.3  (4.22)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine, Placebo
Comments Ha: Drug 2 < Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11
Estimation Comments [Not Specified]
6.Secondary Outcome
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]
Hide Description [Not Specified]
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Hide 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
Overall Number of Participants Analyzed 39 39 27
Mean (Standard Error)
Unit of Measure: Score
-3.0  (0.70) -1.7  (0.67) -2.4  (0.75)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidocaine, Placebo
Comments Ha: Drug 2 < Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lidocaine/Diphenhydramine (Combination) Lidocaine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/39 (76.92%)   30/39 (76.92%)   23/27 (85.19%) 
Gastrointestinal disorders       
Nausea * 1  2/39 (5.13%)  2/39 (5.13%)  2/27 (7.41%) 
Constipation * 1  3/39 (7.69%)  1/39 (2.56%)  0/27 (0.00%) 
Dyspepsia * 1  1/39 (2.56%)  3/39 (7.69%)  0/27 (0.00%) 
General disorders       
Pain * 1  3/39 (7.69%)  0/39 (0.00%)  2/27 (7.41%) 
Pyrexia * 1  0/39 (0.00%)  3/39 (7.69%)  0/27 (0.00%) 
Immune system disorders       
Multiple allergies * 1  2/39 (5.13%)  0/39 (0.00%)  2/27 (7.41%) 
Infections and infestations       
Nasopharyngitis * 1  7/39 (17.95%)  4/39 (10.26%)  6/27 (22.22%) 
Fungal infection * 1  3/39 (7.69%)  4/39 (10.26%)  2/27 (7.41%) 
Vaginal candidiasis * 1  2/39 (5.13%)  4/39 (10.26%)  2/27 (7.41%) 
Urinary tract infection * 1  1/39 (2.56%)  3/39 (7.69%)  1/27 (3.70%) 
Upper respiratory tract infection * 1  1/39 (2.56%)  1/39 (2.56%)  2/27 (7.41%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  3/39 (7.69%)  1/39 (2.56%)  0/27 (0.00%) 
Nervous system disorders       
Headache * 1  8/39 (20.51%)  5/39 (12.82%)  3/27 (11.11%) 
Reproductive system and breast disorders       
Dysmenorrhoea * 1  3/39 (7.69%)  4/39 (10.26%)  4/27 (14.81%) 
Vulvovaginal burning sensation * 1  4/39 (10.26%)  3/39 (7.69%)  4/27 (14.81%) 
Vulvovaginal discomfort * 1  3/39 (7.69%)  4/39 (10.26%)  1/27 (3.70%) 
Vulvovaginal pruritus * 1  1/39 (2.56%)  5/39 (12.82%)  1/27 (3.70%) 
Vaginal Discharge * 1  3/39 (7.69%)  2/39 (5.13%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion * 1  3/39 (7.69%)  0/39 (0.00%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  3/39 (7.69%)  2/39 (5.13%)  0/27 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRa Version 10.1
The study was discontinued following enrollment of 106 of the planned 140 participants due to slow recruitment.
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.
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
Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT00590590     History of Changes
Other Study ID Numbers: LDC-201-601-669020
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: June 30, 2010
Results First Posted: February 9, 2011
Last Update Posted: March 2, 2012