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Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia

Primary Purpose

Vulvodynia, Naltrexone, Quality of Life

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Naltrexone Hydrochloride
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring vulvodynia, low dose naltrexone, quality of life

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing). Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study Signing the patient's informed and voluntary consent to participate in the study. General health of the patient (WHO = 0-2). Diagnosis of vulvodynia. Negative drug test found at the visit randomization. Documented correct cytology result from 3 years ago (before the visit screening). Stable dose of drugs acting on the central nervous system used min. 1 month before the screening visit and during the entire patient's participation in the study. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted. The ability to understand the principles of testing and operating electronic devices. Exclusion Criteria: Severe, hepatic and renal dysfunction defined as: i. An ASPT or ALT result 5 times the upper limit; ii. The level of bilirubin 3 times above the upper limit of normal - excluding patients with Gilbert's syndrome; iii. EGFR result below 30 ml / min / m2, on the basis of historical studies not older than 3 years before the screening visit or from the tests performed during the screening visit according with point 12 of the Protocol, version 1.0 of March 28, 2022. Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit. 4. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide). 5. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life. 6. BTA injection in the vulva in the last 4 months before the screening visit. 7. Endovascular procedures in the area of the small pelvis in the last 6 months before the screening visit. 8. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit. 9. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit. 10. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and / or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times / year). 11. Diagnosis of current or past serious mental disorders according to the criteria of ICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxiety disorders). 12. Gynecological abnormalities requiring medical treatment: current HSIL, CIN II / III, pelvic inflammation, mixed or solid ovarian tumors, simple ovarian cysts greater than 5 cm, abnormal vaginal inter-cycle bleeding. 13. Pelvic venous diseases (PeVD), 4 criteria met on USG. 14. Pregnancy and lactation. 15. Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome and marfan-like syndromes), reactive arthritis (RA). 16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety). 17. Significant and / or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.

Sites / Locations

  • Terpa Limited Liability Company Limited PartnershipRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naltrexone

Placebo

Arm Description

NALTREXONE HYDROCHLORIDE 4,5 mg, coated oral tablets, 1xd. for 4 months

Placebo, coated oral tablets, 1xd.

Outcomes

Primary Outcome Measures

Treatment effectiveness - change in pain intensity
measured by 11-point NRS scale based on spontaneously experienced vulvar and vaginal pain and during vaginal penetration
Treatment effectiveness - change in type and severity of pain
measured by McGill Questionnaire (SF-MPQ)
Treatment effectiveness - change in emotional functioning
Beck Depression Inventory (BDI-II)
Patient's satisfaction
measured by 11-point Lickert scale

Secondary Outcome Measures

Treatment tolerability
Assessment of the tolerability of LDN therapy based on the assessment of side effects and adverse events

Full Information

First Posted
June 6, 2023
Last Updated
July 12, 2023
Sponsor
Medical University of Lublin
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1. Study Identification

Unique Protocol Identification Number
NCT05955313
Brief Title
Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
Official Title
Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vulvodynia (Vd) is chronic functional vulvar pain, with prevalence of 3-16% and unclear etiopathology. Although Vd significantly deteriorates quality of life, the problem is marginalized, no pharmacologic treatment standards exist. Naltrexone hydrochloride is a specific opioid antagonist with slight agonist activity. There is growing body of evidence supporting the effectiveness of low-dose naltrexone (LDN) in different types of chronic pain. The main goal of this trial is to test the effect of LDN on pain perception and quality of life in women with different types of Vd. Half of the study population receives LDN and the remaining patients take placebo, according to randomization list. This RTC is quadruplet blinded.
Detailed Description
In this Randomized Controlled Trial the effectiveness of LDN in reducing chronic pain and improvement of quality of life in women with provoked, spontaneous or mixed vulvodynia is assessed on the basis of the test results recommended according to IMMPACT protocol, compared to the placebo arm. Patients remain in the study for 6 months (4 months of treatment with LDN or placebo). There are 5 visits by a gynecologist (diagnosis of vulvodynia, inclusion and exclusion criteria, randomization), nurse, psychologist and physiotherapist: screening, randomization, control telephone visit, final visit and telephone summary visit. Pain perception and quality of life estimation is reported by the patient in e-diary, validated psychology questionnaires are fulfilled and physical examination acc. Fascial Manipulation (CFMS) L. Stecco method is performed. Tolerability of LDN therapy will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Naltrexone, Quality of Life
Keywords
vulvodynia, low dose naltrexone, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
NALTREXONE HYDROCHLORIDE 4,5 mg, coated oral tablets, 1xd. for 4 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, coated oral tablets, 1xd.
Intervention Type
Drug
Intervention Name(s)
Naltrexone Hydrochloride
Other Intervention Name(s)
naltrexone
Intervention Description
treatment of vulvodynia
Primary Outcome Measure Information:
Title
Treatment effectiveness - change in pain intensity
Description
measured by 11-point NRS scale based on spontaneously experienced vulvar and vaginal pain and during vaginal penetration
Time Frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Title
Treatment effectiveness - change in type and severity of pain
Description
measured by McGill Questionnaire (SF-MPQ)
Time Frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Title
Treatment effectiveness - change in emotional functioning
Description
Beck Depression Inventory (BDI-II)
Time Frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Title
Patient's satisfaction
Description
measured by 11-point Lickert scale
Time Frame
from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Secondary Outcome Measure Information:
Title
Treatment tolerability
Description
Assessment of the tolerability of LDN therapy based on the assessment of side effects and adverse events
Time Frame
throughout the treatment period (from VISIT 2 to VISIT 4) assessed for 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing). Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study Signing the patient's informed and voluntary consent to participate in the study. General health of the patient (WHO = 0-2). Diagnosis of vulvodynia. Negative drug test found at the visit randomization. Documented correct cytology result from 3 years ago (before the visit screening). Stable dose of drugs acting on the central nervous system used min. 1 month before the screening visit and during the entire patient's participation in the study. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted. The ability to understand the principles of testing and operating electronic devices. Exclusion Criteria: Severe, hepatic and renal dysfunction defined as: i. An ASPT or ALT result 5 times the upper limit; ii. The level of bilirubin 3 times above the upper limit of normal - excluding patients with Gilbert's syndrome; iii. EGFR result below 30 ml / min / m2, on the basis of historical studies not older than 3 years before the screening visit or from the tests performed during the screening visit according with point 12 of the Protocol, version 1.0 of March 28, 2022. Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit. 4. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide). 5. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life. 6. BTA injection in the vulva in the last 4 months before the screening visit. 7. Endovascular procedures in the area of the small pelvis in the last 6 months before the screening visit. 8. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit. 9. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit. 10. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and / or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times / year). 11. Diagnosis of current or past serious mental disorders according to the criteria of ICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxiety disorders). 12. Gynecological abnormalities requiring medical treatment: current HSIL, CIN II / III, pelvic inflammation, mixed or solid ovarian tumors, simple ovarian cysts greater than 5 cm, abnormal vaginal inter-cycle bleeding. 13. Pelvic venous diseases (PeVD), 4 criteria met on USG. 14. Pregnancy and lactation. 15. Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome and marfan-like syndromes), reactive arthritis (RA). 16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety). 17. Significant and / or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrzej Stepulak, Professor
Phone
448 52 98
Ext
0048 81
Email
cwnr@umlub.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Baszak-Radomańska, MD, PhD
Organizational Affiliation
Terpa Limited Liability Company Limited partnership
Official's Role
Principal Investigator
Facility Information:
Facility Name
Terpa Limited Liability Company Limited Partnership
City
Lublin
ZIP/Postal Code
20-333
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Baszak, MD, PhD
Phone
501 018 138
Ext
0048
Email
ebarad@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33757151
Citation
Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pilot study of testing a clinical tool for pelvic physical examination in patients with vulvodynia. Ginekol Pol. 2021 Mar 23. doi: 10.5603/GP.a2020.0168. Online ahead of print.
Results Reference
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Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia

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