VulvodyniaPhase 2NCT05955313
Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia
A Phase 2 study testing Naltrexone Hydrochloride in people with Vulvodynia and Naltrexone, run by Medical University of Lublin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vulvodynia, Naltrexone, Quality of Life
- What is being tested?
- Naltrexone Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 31 May 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Severe, hepatic and renal dysfunction defined as:
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Terpa Limited Liability Company Limited Partnership
Lublin, 20-333
Ewa Baszak, MD, PhD, 501 018 138 ext. 0048, ebarad@gmail.com
About this study
Official title: Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia
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.
Read the 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.
- Conditions
- Vulvodynia, Naltrexone, Quality of Life
- Being tested
- Naltrexone Hydrochloride
- Keywords
- vulvodynia, low dose naltrexone, quality of life
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HydrochlorideDrug
Also called naltrexone
treatment of vulvodynia
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | NALTREXONE HYDROCHLORIDE 4,5 mg, coated oral tablets, 1xd. for 4 months Receives: Drug: Naltrexone Hydrochloride |
| Placebo | Placebo comparator | Placebo, coated oral tablets, 1xd. Receives: Drug: Naltrexone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effectiveness - change in pain intensity
measured by 11-point NRS scale based on spontaneously experienced vulvar and vaginal pain and during vaginal penetration
Measured: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Treatment effectiveness - change in type and severity of pain
measured by McGill Questionnaire (SF-MPQ)
Measured: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Treatment effectiveness - change in emotional functioning
Beck Depression Inventory (BDI-II)
Measured: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Patient's satisfaction
measured by 11-point Lickert scale
Measured: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Secondary outcomes (1)
Treatment tolerability
Assessment of the tolerability of LDN therapy based on the assessment of side effects and adverse events
Measured: throughout the treatment period (from VISIT 2 to VISIT 4) assessed for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start31 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Baszak-Radomańska, MD, PhD, Principal investigator, Terpa Limited Liability Company Limited partnership
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955313
- Sponsor's protocol ID
- VN21
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33757151Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pelvic floor examination in vulvodynia: VAMP protocol validation in correlation with central sensitization. Womens Health (Lond). 2025 Jan-Dec;21:17455057251338410. doi: 10.1177/17455057251338410. Epub 2025 Jul 1.
PubMed 40590401
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia
- ClinicalTrials.gov ID
- NCT05955313
- Acronym / sponsor ID
- VN21
- Conditions
- Vulvodynia, Naltrexone, Quality of Life
- Keywords
- vulvodynia, low dose naltrexone, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDE 4,5 mg, coated oral tablets, 1xd. for 4 months |
| Placebo | Placebo comparator | Drug: Naltrexone HydrochloridePlacebo, coated oral tablets, 1xd. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- Severe, hepatic and renal dysfunction defined as:
- 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.
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 |
|---|---|---|
| Naltrexone HydrochlorideAlso: naltrexonetreatment of vulvodynia | Drug | Naltrexone, Placebo |
Primary outcome
Treatment effectiveness - change in pain intensity
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
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
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
measured by McGill Questionnaire (SF-MPQ)
Treatment effectiveness - change in emotional functioning
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
Beck Depression Inventory (BDI-II)
Patient's satisfaction
Time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months
measured by 11-point Lickert scale
1 secondary outcome
Treatment tolerability
Time frame: throughout the treatment period (from VISIT 2 to VISIT 4) assessed for 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Background: PubMed 33757151Baszak-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.
- Derived from this study: PubMed 40590401Baszak-Radomanska E, Wanczyk-Baszak J, Paszkowski T. Pelvic floor examination in vulvodynia: VAMP protocol validation in correlation with central sensitization. Womens Health (Lond). 2025 Jan-Dec;21:17455057251338410. doi: 10.1177/17455057251338410. Epub 2025 Jul 1.
- Individual participant dataSharing planned: No
Related trials for Vulvodynia
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A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
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.
Ewa Baszak-Radomańska, MD, PhD principal investigator
Terpa Limited Liability Company Limited partnership
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone Hydrochloride in people with Vulvodynia and Naltrexone, run by Medical University of Lublin at 1 site in Poland.
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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 21 Jul 2023. 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 Poland. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Stepulak, Professor (448 52 98 ext. 0048 81, cwnr@umlub.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness - change in pain intensity (time frame: from pre-treatment values (VISIT 2) to end of treatment values (VISIT 4) assessed for 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05955313, which also lists 2 linked publications.
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 21 Jul 2023.