Vulvar Pain SymptomsNCT00390013
To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
A study testing Gabapentin in people with Vulvar Pain Symptoms and Vulvodynia (Chronic Vulvar Pain), run by Colleen Stockdale at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Pain Symptoms, Vulvodynia (Chronic Vulvar Pain)
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2008
- Phase
- Interventional
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic.
Who cannot join
- Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Vulvar Pain: Treatment Trial Using Gabapentin-placebo in a Cross-over Design, Pilot Study.
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
Read the detailed description
There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.
- Being tested
- Gabapentin, Placebo oral capsule
- Keywords
- Vulvar Pain
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
- day 1 you will take 1 capsule for the day
- day 2 you will take 1 capsule 2 times for that day
- days 3-6 you will take 1 capsule 3 times for those days
- days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
- days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
- days 13-14 you will take 2 capsules 3 times each day
- continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
- at completion of study treatment you will titrate off study drug over a weeks time.
Placebo oral capsuleDrug
Also called Placebo
Placebo capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
- day 1 you will take 1 capsule for the day
- day 2 you will take 1 capsule 2 times for that day
- days 3-6 you will take 1 capsule 3 times for those days
- days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
- days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
- days 13-14 you will take 2 capsules 3 times each day
- continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
- at completion of study treatment you will titrate off study drug over a weeks time.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) Receives: Drug: Gabapentin |
| Placebo oral capsule | Placebo comparator | Placebo titration and dosing for total of 8 weeks (Cross over) Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Vulvar Pain
change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: poor recruitment
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 Pain SymptomsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colleen Stockdale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Colleen Stockdale, University of Iowa
- Investigators
- Colleen Kennedy Stockdale, M.D., M.S., Principal investigator, University of Iowa Hospital and Clinics, Department of Ob/Gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390013
- Sponsor's protocol ID
- IRB 20060674
- Other IDs
- RR00059, 200606748
- Status last verified
- Jul 2017
- First submitted
- 18 Oct 2006
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulvar Pain: Treatment Trial Using Gabapentin-placebo in a Cross-over Design, Pilot Study.
- ClinicalTrials.gov ID
- NCT00390013
- Acronym / sponsor ID
- IRB 20060674
- Keywords
- Vulvar Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Colleen StockdaleUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Oct 2006 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
Detailed description
There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: GabapentinGabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo titration and dosing for total of 8 weeks (Cross over) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic.
Key exclusion criteria (1 listed)
- Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4).
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 |
|---|---|---|
| GabapentinAlso: Neurontin300 mg. capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: 1. day 1 you will take 1 capsule for the day 2. day 2 you will take 1 capsule 2 times for that day 3. days 3-6 you will take 1 capsule 3 times for those days 4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day 5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day 6. days 13-14 you will take 2 capsules 3 times each day 7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13. 8. at completion of study treatment you will titrate off study drug over a weeks time. | Drug | Gabapentin |
| Placebo oral capsuleAlso: PlaceboPlacebo capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: 1. day 1 you will take 1 capsule for the day 2. day 2 you will take 1 capsule 2 times for that day 3. days 3-6 you will take 1 capsule 3 times for those days 4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day 5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day 6. days 13-14 you will take 2 capsules 3 times each day 7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13. 8. at completion of study treatment you will titrate off study drug over a weeks time. | Drug | Placebo oral capsule |
Primary outcome
Change From Baseline in Vulvar Pain
Time frame: 19 weeks
change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Colleen Kennedy Stockdale, M.D., M.S. principal investigator
University of Iowa Hospital and Clinics, Department of Ob/Gyn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Vulvar Pain Symptoms and Vulvodynia (Chronic Vulvar Pain), run by Colleen Stockdale 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 1 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 31 Jul 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2017). 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?
Change From Baseline in Vulvar Pain (time frame: 19 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 31 Jul 2017.