Vulvar VestibulitisPhase 2NCT00450242

5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

A Phase 2 study testing 5% topical lidocaine ointment in people with Vulvar Vestibulitis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo. This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Vulvar Vestibulitis
What is being tested?: 5% topical lidocaine ointment
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Dec 2006to Jan 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
Healthy volunteers accepted
Adult

Who may be able to join

women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.

Who cannot join

postmenopausal
pure vaginismus
generalized vulvodynia
pudendal neuralgia
pregnant, breastfeeding
less than 2 months post delivery

Show all 10Show fewer

diagnosis of dermatologic condition on biopsy
positive fungal culture
currently on treatment for vvs
history of lidocaine treatment for vvs

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo.
This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

Read the detailed description

After consent is obtained patients will undergo the following treatment plan: randomization to treatment with 5% lidocaine ointment or placebo for vestibulitis. There will be 56 women total (28 in each arm).The placebo used will be hydrophilic petrolatum. Randomization will be performed using computer generated permuted blocks. A standard history and physical exam incorporating assessment of skin allodynia (testing with q-tip swab) on the vestibule and pressure measurements of the pelvic floor muscles (how much tenderness there is on perineal muscles with palpation) will be performed. Baseline questionnaires that will evaluate sexual frequency, sexual function survey (Female sexual function index), the modified Gracely pain scale of intercourse related pain, and psychometric evaluation including evaluation of anxiety, somatization (State-Trait Anxiety Inventory and Brief Symptom Inventory). Depression can also be evaluated with the Brief Symptom Inventory. Lastly, overall quality of health can be assessed with the SF-12. There is a baseline, 2 week and 6 week visit. Women will abstain from intercourse during these 6 weeks. Women will have a physical exam evaluation of the vestibule at each visit. They will then be able to have intercourse and will repeat surveys of sexual frequency, function, pain scale of intercourse related pain and the SF-12 at 8 weeks.
Aim 1: To assess if lidocaine ointment produces a superior treatment response to placebo.
Hypothesis 1: Use of topical lidocaine, compared with placebo, will result in improved sexual function and self-reported pain scores. This is to be measured as the ability to have successful intercourse. Secondarily, sexual function, quality of life and scores for intercourse related pain will be evaluated.
Aim 2: To assess if there are predictors of response to treatment such as demographics, duration of disease, primary or secondary vulvar vestibulitis, or psychometric assessments (anxiety and somatization).
Hypothesis 2: There are predictors of response to treatment of vulvar vestibulitis based upon patient characteristics, characteristics of the disease and psychometric assessments.

Conditions: Vulvar Vestibulitis
Being tested: 5% topical lidocaine ointment, Placebo cream
Keywords: vulvar vestibulitis, vestibulitis
Medical subject headings: Vulvar Vestibulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5% topical lidocaine ointmentDrug
Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.
Placebo creamDrug
hydrophilic petrolatum, dime-sized amount, applied nightly.

Study groups in NCT00450242
Study group	Role	What they receive
5% Lidocaine cream	Experimental	5% topical lidocaine cream. Receives: Drug: 5% topical lidocaine ointment
Placebo cream	Placebo comparator	Not described Receives: Drug: Placebo cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Report the Ability to Have Intercourse
Participants' response upon inquiry.
Measured: baseline, week 8
Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The "mean" listed for each group is average week 8 score subtracted from the average baseline score.
Measured: baseline, week 8

Secondary outcomes (2)

SF-12 Quality of Life Scores
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.
Measured: baseline, week 8
Modified Gracely Pain Scale
The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).
Measured: baseline, week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Jan 2009

First posted22 Mar 2007 (estimated)
Study startDec 2006
Primary completionJan 2009
Study completionJan 2009

Why it stopped: lack of funding

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 Vulvar VestibulitisStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
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: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00450242
Sponsor's protocol ID: 05-2332
Status last verified: Jun 2012
First submitted: 21 Mar 2007
Last updated: 16 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Provoked Vestibulodynia
Recruiting
Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
Vulvodynia, Provoked Vestibulodynia

All Vulvar Vestibulitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of 5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
ClinicalTrials.gov ID: NCT00450242
Acronym / sponsor ID: 05-2332
Conditions: Vulvar Vestibulitis
Keywords: vulvar vestibulitis, vestibulitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of funding
Enrolment: 14 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: Dec 2006
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 22 Mar 2007 (estimated)
Results: Posted 16 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo.
This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

Detailed description

After consent is obtained patients will undergo the following treatment plan: randomization to treatment with 5% lidocaine ointment or placebo for vestibulitis. There will be 56 women total (28 in each arm).The placebo used will be hydrophilic petrolatum. Randomization will be performed using computer generated permuted blocks. A standard history and physical exam incorporating assessment of skin allodynia (testing with q-tip swab) on the vestibule and pressure measurements of the pelvic floor muscles (how much tenderness there is on perineal muscles with palpation) will be performed. Baseline questionnaires that will evaluate sexual frequency, sexual function survey (Female sexual function index), the modified Gracely pain scale of intercourse related pain, and psychometric evaluation including evaluation of anxiety, somatization (State-Trait Anxiety Inventory and Brief Symptom Inventory). Depression can also be evaluated with the Brief Symptom Inventory. Lastly, overall quality of health can be assessed with the SF-12. There is a baseline, 2 week and 6 week visit. Women will abstain from intercourse during these 6 weeks. Women will have a physical exam evaluation of the vestibule at each visit. They will then be able to have intercourse and will repeat surveys of sexual frequency, function, pain scale of intercourse related pain and the SF-12 at 8 weeks.
Aim 1: To assess if lidocaine ointment produces a superior treatment response to placebo.
Hypothesis 1: Use of topical lidocaine, compared with placebo, will result in improved sexual function and self-reported pain scores. This is to be measured as the ability to have successful intercourse. Secondarily, sexual function, quality of life and scores for intercourse related pain will be evaluated.
Aim 2: To assess if there are predictors of response to treatment such as demographics, duration of disease, primary or secondary vulvar vestibulitis, or psychometric assessments (anxiety and somatization).
Hypothesis 2: There are predictors of response to treatment of vulvar vestibulitis based upon patient characteristics, characteristics of the disease and psychometric assessments.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
5% Lidocaine cream	Experimental	Drug: 5% topical lidocaine ointment5% topical lidocaine cream.
Placebo cream	Placebo comparator	Drug: Placebo cream

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.

Key exclusion criteria (10 listed)

postmenopausal
pure vaginismus
generalized vulvodynia
pudendal neuralgia
pregnant, breastfeeding

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
5% topical lidocaine ointmentLidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.	Drug	5% Lidocaine cream
Placebo creamhydrophilic petrolatum, dime-sized amount, applied nightly.	Drug	Placebo cream

Primary outcome

Number of Participants Who Report the Ability to Have Intercourse
Time frame: baseline, week 8
Participants' response upon inquiry.
Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8
Time frame: baseline, week 8
Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The "mean" listed for each group is average week 8 score subtracted from the average baseline score.

2 secondary outcomes

SF-12 Quality of Life Scores
Time frame: baseline, week 8
Modified Gracely Pain Scale
Time frame: baseline, week 8

Results and safety

Results posted to the registry on 16 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5% Lidocaine Cream	7	4
Placebo Cream	7	6

Primary outcome: Number of Participants Who Report the Ability to Have Intercourse

Time frame: baseline, week 8. Number. Unit: participants

Measure	5% Lidocaine Cream n = 4	Placebo Cream n = 6
Value	4	6

Population analysed: Three lidocaine subjects and one control subject failed to complete the study.

Primary outcome: Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8

Time frame: baseline, week 8. Mean (Standard Deviation). Unit: units on a scale

Measure	5% Lidocaine Cream n = 4	Placebo Cream n = 6
Value	2.5 (10.3)	19.7 (24.3)

Population analysed: three lidocaine subjects and one control subject failed to complete the study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5% Lidocaine Cream	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo Cream	0 of 6 (0%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vulvar Vestibulitis

Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Provoked Vestibulodynia
Recruiting
Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
Vulvodynia, Provoked Vestibulodynia

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.

Jacqueline Rohl, MD study director

UNC Division of Advanced Laparoscopy and Pelvic Pain

Denniz Zolnoun, MD MPH principal investigator

UNC- Division of Advanced Laparoscopy and Pelvic Pain

John Steege, MD study chair

UNC Division of Advanced Laparoscopy and Pelvic Pain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5% topical lidocaine ointment in people with Vulvar Vestibulitis, run by University of North Carolina, Chapel Hill at 1 site in United States.

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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 16 Jul 2012). 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?

Number of Participants Who Report the Ability to Have Intercourse (time frame: baseline, week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00450242.

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 16 Jul 2012.