The treatment will be done by using a LLL-probe touching several areas of the vulvar vestibule, according to the selected protocol.
Every patient will be treated twice weekly for 6 weeks.

The patients will be treated with placebo-probe, according to the same protocol

Provoked Vestibulodynia

LOW LEVEL LASER SYSTEM

Ahinoam Lev-Sagie

Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

Response to treatment will be assessed by change in pain by numeric rating scale of a weekly Tampon Test, change in overall daily pain intensity (24 hour numeric rating scale), frequency of sexual intercourse, the change in intercourse pain numeric rating scale, and the cotton swab test pain level by verbal reporting scale. In addition, patients will complete quality-of-life questionnaires (Brief Pain Inventory and Neuropathic Pain Scale)

Clinic for vulvovaginal disorders

Hadassah Medical Organization

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/chronic pain

Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

Vulvar Vestibulitis Clinical Trial: Desipramine-Lidocaine

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