Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)

Placebo titration and dosing for total of 8 weeks (Cross over)

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:
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:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin).

All Cross Over Participants

Gabapentin (Phase 1)

Placebo (Phase 1)

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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.

Gabapentin

Placebo

Change From Baseline in Vulvar Pain

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:
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 cross-over period 1 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).

Gabapentin First Then Placebo Crossover

Placebo titration and dosing for total of 8 weeks (Cross over)
Placebo oral capsule: 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.
at completion of study treatment (week 11) you will titrate off study drug over a weeks time.
Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo).

Placebo Oral Capsule First Then Gabapentin Crossover

1st phase (placebo controlled study) gabapentin 1800 mg max dose

Treatment Only (Gabapentin)

Placebo Control Arm

Phase 1

Phase 2 First Treatment

Phase 2 Second Treatment

Colleen Kennedy Stockdale, MD, MS

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:
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 titration and dosing for total of 8 weeks (Cross over)
Placebo oral capsule: 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.

Placebo Oral Capsule

Vulvar Pain Symptoms

Vulvodynia (Chronic Vulvar Pain)

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 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.

vulvar vestibulitis/neuralgia

To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

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