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| ID | Type | Description | Link |
|---|---|---|---|
| RR00059 | Other Identifier | University of Iowa | |
| 200606748 | Other Identifier | University of Iowa |
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poor recruitment
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The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) |
|
| Placebo oral capsule | Placebo Comparator | Placebo titration and dosing for total of 8 weeks (Cross over) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 300 mg. capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 19 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Kennedy Stockdale, M.D., M.S. | University of Iowa Hospital and Clinics, Department of Ob/Gyn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin First Then Placebo Crossover | 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:
Placebo: Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (gabapentin). |
| FG001 | Placebo Oral Capsule First Then Gabapentin 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:
Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo). |
| FG002 | Treatment Only (Gabapentin) | 1st phase (placebo controlled study) gabapentin 1800 mg max dose |
| FG003 | Placebo Control Arm | 1 phase Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
|
| ||||||||||||||||||
| Phase 2 First Treatment |
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| Phase 2 Second Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Placebo: Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | study terminated early due to poor recruitment | Posted | Mean | Full Range | units on a scale | 19 weeks |
|
|
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participants who received the treatments were monitored
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | 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:
|
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Lack of enrollment leading to early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen Kennedy Stockdale, MD, MS | University of Iowa | 319-384-6849 | colleen-stockdale@uiowa.edu |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| Placebo oral capsule | Drug | Placebo capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
|
|
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Gabapentin (Phase 1) |
| BG002 | Placebo (Phase 1) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo Oral Capsule | 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:
| 0 | 6 | 0 | 6 | 0 | 6 |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |