Female Genital DiseasesPhase 2/3TopicalsNCT02099006
Novel Topical Therapies for the Treatment of Genital Pain
A Phase 2/3 study testing Amitriptyline, Baclofen and Ketoprofen in people with Female Genital Diseases, run by University of Rochester at 1 site in United States.
Trial summary
This study is testing drugs not previously used topically for the treatment of vulvodynia, a common genital pain syndrome. It is hoped that one of these drugs will improve vaginal entryway pain with touch, daily pain scores and sexual functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Female Genital Diseases
- What is being tested?
- Amitriptyline, Baclofen and Ketoprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- Phase
- Phase 2/3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between ages of 18 and 65 who complain of localized provoked vulvar pain and meet the criteria for the diagnosis of localized provoked vulvodynia. Patients who have failed or have been unable to tolerate previous attempts at systematic therapy or surgery will be specifically recruited.
Who cannot join
- The presence of a dermatologic or neurologic condition which is determined by the investigator to be the primary cause of the patient's pain.
- Allergy to any of the medications or the base itself.
- Concurrent use of the following medications. . The patient may enroll in the study after a two week washout from these medications. Patients may need to receive approval from the prescribing physician before stopping these medications. Failure to obtain approval for medication cessation would be cause for exclusion.
- Gabapentin (NeurontinTM) Amitriptyline (ElavilTM) Nortriptyline (PamelorTM) Desipramine (NorpraminTM) Tramadol (UltramTM, ConZipTM, RybixTM, RysoltTM, Ultram ERTM) Pregabalin (LyricaTM) Baclofen
Trial locations and contacts
1 site in 1 country.
About this study
This study is testing drugs not previously used topically for the treatment of vulvodynia, a common genital pain syndrome. It is hoped that one of these drugs will improve vaginal entryway pain with touch, daily pain scores and sexual functioning.
Read the detailed description
Vulvodynia is defined as burning pain, occurring in the absence of any visible finding or a clinically identifiable nervous disorder. Current treatments include vulvar care measure, topical medications, oral medications, biofeedback, physical therapy and surgery. The usual treatment is to have the patient take either tricyclic antidepressants or anti convulsants orally, however these methods seldom bring total relief. These drugs do have significant side effects limiting the patient's tolerance of the higher does sometimes needed. An effective topical medication would greatly benefit these women with fewer side effects and better tolerance. Topical amitriptyline and baclofen are often prescribed, but no studies have been done to support their use. Topical gabapentin has also been shown to have good effect, but no prospective clinical study as been done.
This study will test topical application of Cetaphil, Loperamide, Gabapentin, Ketoprofen, Ketamine and Amitriptyline over a 19 week period in the first phase of the study. The drugs are compounded by the University of Rochester research pharmacy and dispensed in 19 vials, one vial to be used each week. Patients and study personnel are blinded as to which drug is being used. Each study participant was given a week of placebo at the initiation of the study. Each study compound, which contains both the drug and the base (Cetaphil) will be used twice a day for two weeks in a row, followed by a one week washout of base alone. If a patient finds that one of the drugs is effective she may stop participation after the first 13 weeks and request that the most effective drug be prescribed for her. The unblinding officer would then work with the research pharmacy to identify the effective drug and provide the patient with a prescription for that drug. If the patient desires, she may enroll in the second phase of the study when she will test the last two drugs over a six week period with the washout as in the first segment of the study. The drugs would be administered in vials as in the first section of the study.
Every week on Sunday the patient will complete an electronic diary, recording her daily pain, any drug side effects, pain with the tampon test and overall health. Every three weeks she will complete the Female Sexual Function Index on the same electronic system. She would start her new drug on Monday each week. Additionally the coordinator of the study will call each patient on Wednesday to see if they are having any problems with the drug started on Monday.
All patients who could become pregnant are required to maintain effective contraception throughout the study.
- Conditions
- Female Genital Diseases
- Being tested
- Amitriptyline, Baclofen, Ketoprofen, Ketamine, Loperamide
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Also called Elavil
Topical application of the drug at a 2% concentration in combination with 2% Baclofen
BaclofenDrug
Also called Lioresal
Used topically at 2% concentration in combination with 2% amitriptyline
KetoprofenDrug
Also called Orudis, Oruvail, Nexcede, Orudis KT
To be applied topically at a 10% concentration
KetamineDrug
Also called Ketalar
To be applied topically at a 10% concentration
LoperamideDrug
Also called Imodium, Imotil, Kaopectate
To be applied topically at a 5% concentration
GabapentinDrug
Also called Neurontin
To be applied topically at a 6% concentration
placeboDrug
Also called Cetaphil
Compounding base to be used alone as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Medications | Experimental | Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. Receives: Drug: Amitriptyline; Drug: Baclofen; Drug: Ketoprofen; Drug: Ketamine; Drug: Loperamide; Drug: Gabapentin |
| Placebo | Placebo comparator | The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Daily Genital Pain.
Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of "0" was defined as no pain and a score of "10" was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated.
Measured: 13 weeks
Secondary outcomes (1)
Reduction in Tampon Test Pain
Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of "0" was defined as no pain, and a score of "10" was defined as worst imaginable pain.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
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 Female Genital DiseasesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Mae Stone Goode Foundation
- Responsible party
- Principal investigator, Adrienne Bonham, University of Rochester
- Investigators
- Adrienne D Bonham, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099006
- Sponsor's protocol ID
- 46905
- Acronym
- Topicals
- Status last verified
- Jul 2016
- First submitted
- 25 Mar 2014
- Last updated
- 15 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Topical Therapies for the Treatment of Genital Pain
- ClinicalTrials.gov ID
- NCT02099006
- Acronym / sponsor ID
- Topicals / 46905
- Conditions
- Female Genital Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Mae Stone Goode Foundation
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing drugs not previously used topically for the treatment of vulvodynia, a common genital pain syndrome. It is hoped that one of these drugs will improve vaginal entryway pain with touch, daily pain scores and sexual functioning.
Detailed description
Vulvodynia is defined as burning pain, occurring in the absence of any visible finding or a clinically identifiable nervous disorder. Current treatments include vulvar care measure, topical medications, oral medications, biofeedback, physical therapy and surgery. The usual treatment is to have the patient take either tricyclic antidepressants or anti convulsants orally, however these methods seldom bring total relief. These drugs do have significant side effects limiting the patient's tolerance of the higher does sometimes needed. An effective topical medication would greatly benefit these women with fewer side effects and better tolerance. Topical amitriptyline and baclofen are often prescribed, but no studies have been done to support their use. Topical gabapentin has also been shown to have good effect, but no prospective clinical study as been done.
This study will test topical application of Cetaphil, Loperamide, Gabapentin, Ketoprofen, Ketamine and Amitriptyline over a 19 week period in the first phase of the study. The drugs are compounded by the University of Rochester research pharmacy and dispensed in 19 vials, one vial to be used each week. Patients and study personnel are blinded as to which drug is being used. Each study participant was given a week of placebo at the initiation of the study. Each study compound, which contains both the drug and the base (Cetaphil) will be used twice a day for two weeks in a row, followed by a one week washout of base alone. If a patient finds that one of the drugs is effective she may stop participation after the first 13 weeks and request that the most effective drug be prescribed for her. The unblinding officer would then work with the research pharmacy to identify the effective drug and provide the patient with a prescription for that drug. If the patient desires, she may enroll in the second phase of the study when she will test the last two drugs over a six week period with the washout as in the first segment of the study. The drugs would be administered in vials as in the first section of the study.
Every week on Sunday the patient will complete an electronic diary, recording her daily pain, any drug side effects, pain with the tampon test and overall health. Every three weeks she will complete the Female Sexual Function Index on the same electronic system. She would start her new drug on Monday each week. Additionally the coordinator of the study will call each patient on Wednesday to see if they are having any problems with the drug started on Monday.
All patients who could become pregnant are required to maintain effective contraception throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medications | Experimental | Drug: Amitriptyline, Drug: Baclofen, Drug: Ketoprofen, Drug: Ketamine, Drug: Loperamide, Drug: GabapentinEach study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. |
| Placebo | Placebo comparator | Drug: placeboThe compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women between ages of 18 and 65 who complain of localized provoked vulvar pain and meet the criteria for the diagnosis of localized provoked vulvodynia. Patients who have failed or have been unable to tolerate previous attempts at systematic therapy or surgery will be specifically recruited.
Key exclusion criteria (4 listed)
- The presence of a dermatologic or neurologic condition which is determined by the investigator to be the primary cause of the patient's pain.
- Allergy to any of the medications or the base itself.
- Concurrent use of the following medications. . The patient may enroll in the study after a two week washout from these medications. Patients may need to receive approval from the prescribing physician before stopping these medications. Failure to obtain approval for medication cessation would be cause for exclusion.
- Gabapentin (NeurontinTM) Amitriptyline (ElavilTM) Nortriptyline (PamelorTM) Desipramine (NorpraminTM) Tramadol (UltramTM, ConZipTM, RybixTM, RysoltTM, Ultram ERTM) Pregabalin (LyricaTM) Baclofen
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 |
|---|---|---|
| AmitriptylineAlso: ElavilTopical application of the drug at a 2% concentration in combination with 2% Baclofen | Drug | Medications |
| BaclofenAlso: LioresalUsed topically at 2% concentration in combination with 2% amitriptyline | Drug | Medications |
| KetoprofenAlso: Orudis, Oruvail, Nexcede, Orudis KTTo be applied topically at a 10% concentration | Drug | Medications |
| KetamineAlso: KetalarTo be applied topically at a 10% concentration | Drug | Medications |
| LoperamideAlso: Imodium, Imotil, KaopectateTo be applied topically at a 5% concentration | Drug | Medications |
| GabapentinAlso: NeurontinTo be applied topically at a 6% concentration | Drug | Medications |
| placeboAlso: CetaphilCompounding base to be used alone as a placebo | Drug | Placebo |
Primary outcome
Reduction in Daily Genital Pain.
Time frame: 13 weeks
Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of "0" was defined as no pain and a score of "10" was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated.
1 secondary outcome
Reduction in Tampon Test Pain
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adrienne D Bonham, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amitriptyline, Baclofen and Ketoprofen in people with Female Genital Diseases, run by University of Rochester 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 4 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: finished, as of the sponsor's last update on 15 Jul 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2016). 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?
Reduction in Daily Genital Pain. (time frame: 13 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 15 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.