VestibulodyniaPhase 3NCT01304589
Savella in Treatment for Provoked Vestibulodynia
A Phase 3 study testing Milnacipran in people with Vestibulodynia and Vulvodynia, run by University of Tennessee at 1 site in United States.
Trial summary
The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vestibulodynia, Vulvodynia
- What is being tested?
- Milnacipran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2012
- Phase
- Phase 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 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women between 18-54 years of age,
- 'Friedrich's Criteria' must be met (report greater than six continuous months of vulvar symptoms including insertional dyspareunia or pain to touch, demonstrate on physical exam moderate to severe tenderness to light touch, localized to the vulvar vestibule [positive Cotton Swab Test] and demonstration of variable degrees of erythema of the vestibule),
- an average pain level of "4" or greater on the 10-point tampon test and/or an average pain level of "4" or greater on the sexual intercourse pain scale(0 = no pain at all; 10 = worse pain ever) during the 2-week screening period(see Study Parameters Section), and
- willing to use two forms of contraception during the study.
Who cannot join
- other vulvar conditions, including dermatoses, vulvitis, vulvar papillomatosis, and atrophic vaginitis (presence of a maturation index),
- previous vestibulectomy,
- active vaginal infection,
- neuropathology, including seizure disorder or syncopal episodes,
- pregnancy or at risk for pregnancy and not using a reliable birth control method for at least 3 months prior to entering the study,
- breastfeeding,
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- major medical illness including chronic liver disease/hepatic impairment, renal impairment, narrow-angle glaucoma, or uncontrolled hypertension,
- major psychiatric illness including substance abuse,
- multiple allergies (greater than three drugs or environmental agents),
- use of centrally-acting agents, including monoamine oxidase inhibitors, benzodiazepines, opiates, muscle relaxants, and antidepressants within 2 weeks of randomization and during the study, and
- use of topical lidocaine, within 2 weeks of randomization and during the study, as it has shown to be an effective treatment in some women, while worsening symptoms in others. Subjects will be permitted to take acetaminophen, aspirin, or a nonsteroidal anti-inflammatory drug as rescue medication. They will be provided with a list of allowable escape medications and those which would constitute a protocol deviation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health Specialists, PLLC
Germantown, Tennessee, 38138
About this study
Official title: An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia
The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determine whether associated symptoms in PVD, including psychological distress, impairment of sexual function, physical function, and quality of life, are correlated with a reduction in vulvar pain.
Read the detailed description
This is an 18-week, open-label, flexible-dose "proof of concept" trial where women with a diagnosis of vestibulodynia will be evaluated at baseline for eligibility. Eligible patients will be openly treated with 200 mg/d milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involves 4 phases: screening and washout, baseline assessment, dose escalation, and stable-dose phase (Figure 1). After completing a 2-week washout of prohibited medications, patients will enter a 2-week baseline period, where they will be trained in the use of daily diaries and the tampon test, and baseline safety and efficacy data will be recorded. Patients who continue to meet the eligibility criteria at the end of the baseline period will begin a 6-week period of dose escalation. All patients will be scheduled to receive a total of 12 weeks of stable dose treatment after the 6-week dose-escalation period for a total of 18 weeks of drug exposure.
- Conditions
- Vestibulodynia, Vulvodynia
- Being tested
- Milnacipran
- Keywords
- provoked vestibulodynia, vulvodynia, PVD
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Also called Savella
6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Milnacipran | Experimental | This was an 18-week, open-label, flexible-dose exploratory trial where eligible patients were treated with 200 mg/day of milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involved 3 phases: screening and baseline assessment, dose escalation and stable-dose phase. All women received 12 weeks of stable dose treatment after a 6-week dose-escalation period for a total of 18 weeks of drug exposure. Receives: Drug: Milnacipran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating Index
The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. "0" equals no pain to "45" equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
Measured: 18 weeks
Secondary outcomes (3)
Tampon Pain
"0" equals no pain with tampon insertion to "10" equals worse pain imaginable with tampon insertion. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
Measured: 18 weeks
Coital Pain
"0" equals no pain with intercourse to "10" equals worse imaginable pain with intercourse. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
Measured: 18 weeks
24-hour Vulvar Pain
"0" equals no vulvar pain within the last 24 hours to "10" equals worse imaginable vulvar pain within the last 24 hours. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2012
- Study completionSep 2012
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 VestibulodyniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Candace Brown, MSN, Pharm.D., University of Tennessee
- Investigators
- Candace S Brown, PharmD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304589
- Sponsor's protocol ID
- CSBrown SAV-MD-18
- Status last verified
- May 2018
- First submitted
- 24 Feb 2011
- Last updated
- 11 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia
- ClinicalTrials.gov ID
- NCT01304589
- Acronym / sponsor ID
- CSBrown SAV-MD-18
- Conditions
- Vestibulodynia, Vulvodynia
- Keywords
- provoked vestibulodynia, vulvodynia, PVD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determine whether associated symptoms in PVD, including psychological distress, impairment of sexual function, physical function, and quality of life, are correlated with a reduction in vulvar pain.
Detailed description
This is an 18-week, open-label, flexible-dose "proof of concept" trial where women with a diagnosis of vestibulodynia will be evaluated at baseline for eligibility. Eligible patients will be openly treated with 200 mg/d milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involves 4 phases: screening and washout, baseline assessment, dose escalation, and stable-dose phase (Figure 1). After completing a 2-week washout of prohibited medications, patients will enter a 2-week baseline period, where they will be trained in the use of daily diaries and the tampon test, and baseline safety and efficacy data will be recorded. Patients who continue to meet the eligibility criteria at the end of the baseline period will begin a 6-week period of dose escalation. All patients will be scheduled to receive a total of 12 weeks of stable dose treatment after the 6-week dose-escalation period for a total of 18 weeks of drug exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milnacipran | Experimental | Drug: MilnacipranThis was an 18-week, open-label, flexible-dose exploratory trial where eligible patients were treated with 200 mg/day of milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involved 3 phases: screening and baseline assessment, dose escalation and stable-dose phase. All women received 12 weeks of stable dose treatment after a 6-week dose-escalation period for a total of 18 weeks of drug exposure. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women between 18-54 years of age,
- 'Friedrich's Criteria' must be met (report greater than six continuous months of vulvar symptoms including insertional dyspareunia or pain to touch, demonstrate on physical exam moderate to severe tenderness to light touch, localized to the vulvar vestibule [positive Cotton Swab Test] and demonstration of variable degrees of erythema of the vestibule),
- an average pain level of "4" or greater on the 10-point tampon test and/or an average pain level of "4" or greater on the sexual intercourse pain scale(0 = no pain at all; 10 = worse pain ever) during the 2-week screening period(see Study Parameters Section), and
- willing to use two forms of contraception during the study.
Key exclusion criteria (11 listed)
- other vulvar conditions, including dermatoses, vulvitis, vulvar papillomatosis, and atrophic vaginitis (presence of a maturation index),
- previous vestibulectomy,
- active vaginal infection,
- neuropathology, including seizure disorder or syncopal episodes,
- pregnancy or at risk for pregnancy and not using a reliable birth control method for at least 3 months prior to entering the study,
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 |
|---|---|---|
| MilnacipranAlso: Savella6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks | Drug | Milnacipran |
Primary outcome
Pain Rating Index
Time frame: 18 weeks
The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. "0" equals no pain to "45" equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
3 secondary outcomes
Tampon Pain
Time frame: 18 weeks
Coital Pain
Time frame: 18 weeks
24-hour Vulvar Pain
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vestibulodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
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Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
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Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
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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.
Candace S Brown, PharmD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Milnacipran in people with Vestibulodynia and Vulvodynia, run by University of Tennessee 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 4 inclusion and 11 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 11 Jun 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 2 Apr 2014). 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?
Pain Rating Index (time frame: 18 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 11 Jun 2018.