Savella in Treatment for Provoked Vestibulodynia

NCT01304589 | Completed Phase 3 Results

• 1 other identifier: CSBrown SAV-MD-18
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibulodynia; Vulvodynia

Keywords

provoked vestibulodynia; vulvodynia; PVD

Outcome Measures

Primary Outcomes (1)

• 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.

  18 weeks

Secondary Outcomes (3)

• Tampon Pain

  18 weeks

• Coital Pain

  18 weeks

• 24-hour Vulvar Pain

  18 weeks

Study Arms (1)

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.

Drug: Milnacipran

Interventions

Milnacipran DRUG

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

Also known as: Savella

Milnacipran

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead
• Forest Laboratories: collaborator

Study Sites (1)

Women's Health Specialists, PLLC

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Vulvodynia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Candace Brown
• Organization: University of Tennessee Health Science Center

csbrown@uthsc.edu

901-412-4341

Study Officials

• Candace S Brown, PharmD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Clinical Pharmacy, Psychiatry and Obstetrics/Gynecology

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 11, 2018
• Results First Posted: April 2, 2014

Record last verified: 2018-05

Locations

US (1)