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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 (Placebo) | Placebo Comparator |
| |
| 1 (Lidocaine) | Experimental |
| |
| 2 (Lidocaine/Diphenhydramine) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine/Diphenhydramine | Drug | semi solid, twice weekly, 4 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) | 0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse | Baseline -12 Weeks |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Joffrion | Lumara Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery Women's Health Associates, P.C. | Montgomery | Alabama | 36116 | United States | ||
| Star W. Research |
Participants will undergo a screening period of two weeks prior to study assignment.
Participants were recruited from 31 physician offices in the US and Canada between 04Sep2007 to 18Mar2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine/Diphenhydramine (Combination) | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months |
| FG001 | Lidocaine | Lidocaine administered twice weekly for 4 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| lidocaine |
| Drug |
semi solid, twice weekly for 4 months |
|
| placebo | Drug | semi solid, twice weekly for 4 months |
|
| 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 |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Precision Trials LLC | Phoenix | Arizona | 85032 | United States |
| Searcy Medical Center | Searcy | Arkansas | 72143 | United States |
| Universal Biopharma Research Institute, Inc. | Dinuba | California | 93618 | United States |
| San Diego Clinical Research Center | San Diego | California | 92103 | United States |
| Red Rocks OB/GYN | Lakewood | Colorado | 80228 | United States |
| Taylor Associates/Gynecology | Farmington | Connecticut | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| Clinical Research of Tampa Bay | Hudson | Florida | 34667 | United States |
| Innovative Research of W. Florida | Largo | Florida | 33770 | United States |
| Women's Health Care Specialists, PC | Paw Paw | Florida | 49079 | United States |
| Tampa Bay Women's Healthcare Alliance, LLP | Tampa | Florida | 33607 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Atlanta Women's Research Institute, Inc. | Atlanta | Georgia | 30342 | United States |
| Atlanta North Gynecology, PC | Roswell | Georgia | 30075 | United States |
| Womans Clinic | Boise | Idaho | 83712 | United States |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Women's Health Practice, LLC | Champaign | Illinois | 61820 | United States |
| Northern Indiana Womens Health Research | South Bend | Indiana | 46601 | United States |
| Female Pelvic Medicine and Urogynecology | Grand Rapids | Michigan | 49506 | United States |
| Boro Park ObGyn | Brooklyn | New York | 11219 | United States |
| Eastern Carolina Womens Center | New Bern | North Carolina | 28562 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Winston-Salem Woman Care, PA | Winston-Salem | North Carolina | 27103 | United States |
| Holzer Clinic | Gallipolis | Ohio | 45631 | United States |
| HWC Women's Research Center | Miamisburg | Ohio | 45342 | United States |
| Advanced Clinical Research | Medford | Oregon | 97504 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18105 | United States |
| Advanced Clinical Concepts | West Reading | Pennsylvania | 19611 | United States |
| Hillcrest Clinical Research, LLC | Simpsonville | South Carolina | 29681 | United States |
| Southeastern Clinical Research | Chattanooga | Tennessee | 37403 | United States |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | United States |
| Women's Care Center, PLC | Memphis | Tennessee | 38119 | United States |
| Gynecology and Obstetrics, P.C. | Memphis | Tennessee | 38120 | United States |
| Professional Quality Research/Women Partners | Austin | Texas | 78705 | United States |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | United States |
| Woman's Hospital of Texas | Houston | Texas | 77054 | United States |
| Bexar Clinical Trials | Irving | Texas | 75061 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84107 | United States |
| Salt Lake Women's Center | Sandy City | Utah | 84070 | United States |
| Gain Medical Centre | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Stephen Kaye, MD | North Vancouver | British Columbia | V7M 2H5 | Canada |
| Southern Healthcare Centre | White Rock | British Columbia | V4B 5C9 | Canada |
| Common Wealth Medical Clinic | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| The Ottawa Hospital-Soundcare Medical Centre | Ottawa | Ontario | K1V 0Y3 | Canada |
| Royal Health Care Centre | Toronto | Ontario | M5H 3P5 | Canada |
| Windsor Metropolitan Hospital | Windsor | Ontario | N8X 3V6 | Canada |
| FG002 | Placebo | Placebo administered twice weekly for 4 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine/Diphenhydramine (Combination) | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months |
| BG001 | Lidocaine | Lidocaine administered twice weekly for 4 months |
| BG002 | Placebo | Placebo administered twice weekly for 4 months |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (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 | Posted | Mean | Standard Error | scores on a scale | 12 weeks |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) | 0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse | Posted | Mean | Standard Error | Score | Baseline -12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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] | Posted | Mean | Standard Error | Score | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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] | Posted | Mean | Standard Error | Score | 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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] | Posted | Mean | Standard Error | Score | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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] | Posted | Mean | Standard Error | Score | 12 Weeks |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine/Diphenhydramine (Combination) | Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months | 0 | 39 | 30 | 39 | ||
| EG001 | Lidocaine | Lidocaine administered twice weekly for 4 months | 0 | 39 | 30 | 39 | ||
| EG002 | Placebo | Placebo administered twice weekly for 4 months | 0 | 27 | 23 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Vaginal candidiasis | Infections and infestations | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRa Version 10.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.1 | Non-systematic Assessment |
|
The study was discontinued following enrollment of 106 of the planned 140 participants due to slow recruitment.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim Joffrion, Sr. Director, Clinical Affairs | KV Pharmaceutical | 314-645-6600 | jjoffrion@kvph.com |
| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Canada |
|
| Mean Difference (Final Values) |
| 0.1 |
| No |
| Superiority or Other |
| Ha: Drug 2 < Placebo | Mean Difference (Final Values) | 0.1 | No | Superiority or Other |
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