Savella in Treatment for Provoked Vestibulodynia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Vestibulodynia Vulvodynia	Drug: Milnacipran	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia

Resource links provided by NLM:

Drug Information available for: Milnacipran Milnacipran hydrochloride

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:

The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD) [ Time Frame: Visit 2 (baseline) thru Visit 6 (End of treatment) - 18 weeks of treatment ] [ Designated as safety issue: No ]
The primary outcome measure will be pain ratings on the Pain Rating Index (PRI) of the short-form McGill Pain Questionnaire (SF-MPQ), which consists of 15 representative words from the sensory (n = 11) and affective (N = 4) categories of the standard, long-form (LF-MPQ). On the PRI, each descriptor is ranked by the patient on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe.

Secondary Outcome Measures:

diary-rated coital pain and tampon insertion test pain [ Time Frame: Visit 1 (screening) thru Visit 6 (End of Treatment) - 20 weeks ] [ Designated as safety issue: No ]
Secondary outcome measures will include other measures of pain intensity (diary-rated coital and tampon insertion pain), physical functioning, emotional and sexual functioning, global rating of improvement, and quality of life.

Enrollment:	31
Study Start Date:	October 2010
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Milnacipran	Drug: Milnacipran 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 Other Name: Savella

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.

Eligibility

Ages Eligible for Study:	18 Years to 54 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304589

Locations

United States, Tennessee
Women's Health Specialists, PLLC
Germantown, Tennessee, United States, 38138

Sponsors and Collaborators

University of Tennessee

Forest Laboratories

Investigators

Principal Investigator:

Candace S Brown, PharmD

University of Tennessee Health Science Center

More Information

No publications provided

Responsible Party:	Candace Brown, MSN, Pharm.D., Professor, Departments of Clinical Pharmacy, Psychiatry and Obstetrics/Gynecology, University of Tennessee
ClinicalTrials.gov Identifier:	NCT01304589 History of Changes
Other Study ID Numbers:	CSBrown SAV-MD-18
Study First Received:	February 24, 2011
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by University of Tennessee:

provoked vestibulodynia
vulvodynia
PVD

Additional relevant MeSH terms:

Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on May 23, 2013