VulvodyniaPhase 2NCT00590590
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
A Phase 2 study testing Lidocaine/Diphenhydramine and lidocaine in people with Vulvodynia, run by Lumara Health, Inc. at 48 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Lidocaine/Diphenhydramine and lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have sought doctor's care for this condition.
- Patients must be having menstrual cycles.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States41 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, 30342
Professional Quality Research/Women Partners
Austin, Texas, 78705
Womans Clinic
Boise, Idaho, 83712
Boro Park ObGyn
Brooklyn, New York, 11219
Women's Health Practice, LLC
Champaign, Illinois, 61820
Star W. Research
Chandler, Arizona, 85225
Southeastern Clinical Research
Chattanooga, Tennessee, 37403
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Advanced Research Associates
Corpus Christi, Texas, 78414
Universal Biopharma Research Institute, Inc.
Dinuba, California, 93618
Taylor Associates/Gynecology
Farmington, Connecticut
Holzer Clinic
Gallipolis, Ohio, 45631
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, 49506
Woman's Hospital of Texas
Houston, Texas, 77054
Clinical Research of Tampa Bay
Hudson, Florida, 34667
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Bexar Clinical Trials
Irving, Texas, 75061
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Red Rocks OB/GYN
Lakewood, Colorado, 80228
Innovative Research of W. Florida
Largo, Florida, 33770
Advanced Clinical Research
Medford, Oregon, 97504
Women's Care Center, PLC
Memphis, Tennessee, 38119
Gynecology and Obstetrics, P.C.
Memphis, Tennessee, 38120
HWC Women's Research Center
Miamisburg, Ohio, 45342
Montgomery Women's Health Associates, P.C.
Montgomery, Alabama, 36116
Eastern Carolina Womens Center
New Bern, North Carolina, 28562
Women's Health Care Specialists, PC
Paw Paw, Florida, 49079
Precision Trials LLC
Phoenix, Arizona, 85032
Atlanta North Gynecology, PC
Roswell, Georgia, 30075
Salt Lake Research
Salt Lake City, Utah, 84107
San Diego Clinical Research Center
San Diego, California, 92103
Salt Lake Women's Center
Sandy City, Utah, 84070
Searcy Medical Center
Searcy, Arkansas, 72143
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681
Northern Indiana Womens Health Research
South Bend, Indiana, 46601
Tampa Bay Women's Healthcare Alliance, LLP
Tampa, Florida, 33607
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Advanced Clinical Concepts
West Reading, Pennsylvania, 19611
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Winston-Salem Woman Care, PA
Winston-Salem, North Carolina, 27103
Canada7 sites
Gain Medical Centre
Coquitlam, British Columbia, V3K 3P4
Common Wealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Stephen Kaye, MD
North Vancouver, British Columbia, V7M 2H5
The Ottawa Hospital-Soundcare Medical Centre
Ottawa, Ontario, K1V 0Y3
Royal Health Care Centre
Toronto, Ontario, M5H 3P5
Southern Healthcare Centre
White Rock, British Columbia, V4B 5C9
Windsor Metropolitan Hospital
Windsor, Ontario, N8X 3V6
About this study
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.
- Conditions
- Vulvodynia
- Being tested
- Lidocaine/Diphenhydramine, lidocaine, placebo
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine/DiphenhydramineDrug
semi solid, twice weekly, 4 months
lidocaineDrug
semi solid, twice weekly for 4 months
placeboDrug
semi solid, twice weekly for 4 months
| Study group | Role | What they receive |
|---|---|---|
| 3 (Placebo) | Placebo comparator | Not described Receives: Drug: placebo |
| 1 (Lidocaine) | Experimental | Not described Receives: Drug: lidocaine |
| 2 (Lidocaine/Diphenhydramine) | Experimental | Not described Receives: Drug: Lidocaine/Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (5)
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
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumara Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Joffrion, Study director, Lumara Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590590
- Sponsor's protocol ID
- LDC-201-601-669020
- Status last verified
- Feb 2012
- First submitted
- 26 Dec 2007
- Last updated
- 2 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
- ClinicalTrials.gov ID
- NCT00590590
- Acronym / sponsor ID
- LDC-201-601-669020
- Conditions
- Vulvodynia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Lumara Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 9 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 (Placebo) | Placebo comparator | Drug: placebo |
| 1 (Lidocaine) | Experimental | Drug: lidocaine |
| 2 (Lidocaine/Diphenhydramine) | Experimental | Drug: Lidocaine/Diphenhydramine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients must have sought doctor's care for this condition.
- Patients must be having menstrual cycles.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine/Diphenhydraminesemi solid, twice weekly, 4 months | Drug | 2 (Lidocaine/Diphenhydramine) |
| lidocainesemi solid, twice weekly for 4 months | Drug | 1 (Lidocaine) |
| placebosemi solid, twice weekly for 4 months | Drug | 3 (Placebo) |
Primary outcome
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
Time frame: 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
5 secondary outcomes
Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vulvodynia
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Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
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Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Joffrion study director
Lumara Health, Inc.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine/Diphenhydramine and lidocaine in people with Vulvodynia, run by Lumara Health, Inc. at 48 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.