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Savella in Treatment for Provoked Vestibulodynia

Primary Purpose

Vestibulodynia, Vulvodynia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Milnacipran

About this trial

This is an interventional treatment trial for Vestibulodynia focused on measuring provoked vestibulodynia, vulvodynia, PVD

Eligibility Criteria

18 Years - 54 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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,
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.

Sites / Locations

Women's Health Specialists, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Milnacipran

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01304589

First Posted

February 24, 2011

Last Updated

May 9, 2018

Sponsor

University of Tennessee

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01304589

Brief Title

Savella in Treatment for Provoked Vestibulodynia

Official Title

An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Tennessee

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vestibulodynia, Vulvodynia

Keywords

provoked vestibulodynia, vulvodynia, PVD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Milnacipran

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Milnacipran

Other Intervention Name(s)

Savella

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain Rating Index

Description

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Tampon Pain

Description

"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.

Time Frame

18 weeks

Title

Coital Pain

Description

"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.

Time Frame

18 weeks

Title

24-hour Vulvar Pain

Description

Time Frame

18 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

54 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Candace S Brown, PharmD

Organizational Affiliation

University of Tennessee

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's Health Specialists, PLLC

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

12. IPD Sharing Statement

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Savella in Treatment for Provoked Vestibulodynia

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