Vulvar Pain Symptoms, Vulvodynia (Chronic Vulvar Pain)
Conditions
Keywords
Vulvar Pain
Brief summary
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.
Interventions
DRUGGabapentin
300 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.
DRUGPlacebo oral capsule
Placebo 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.
Sponsors
Colleen Stockdale
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Vulvar Pain | 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. |
Countries
United States
Participant flow
Pre-assignment details
Study has 2 phases: first was a placebo controlled randomized study (4 participants) second was a cross-over study (5 participants - 2 did not cross over)
Participants by arm
| Arm | Count |
|---|---|
| All Cross Over Participants Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 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.
Placebo:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin). | 5 |
| Gabapentin (Phase 1) | 2 |
| Placebo (Phase 1) | 2 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase 1 | tired | 0 | 0 | 0 | 1 |
| Phase 2 First Treatment | tired | 1 | 0 | 0 | 0 |
| Phase 2 First Treatment | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Cross Over Participants | Gabapentin (Phase 1) | Placebo (Phase 1) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: 19 weeks
Population: study terminated early due to poor recruitment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gabapentin | Change From Baseline in Vulvar Pain | -1.3 units on a scale |
| Placebo | Change From Baseline in Vulvar Pain | -1.3 units on a scale |