EUCTR2022-000245-33-PL进行中（未招募）1 期
To evaluate the effect of low-dose naltrexone (LDN) on pain perception and quality of life in women - To evaluate the effect of low-dose naltrexone (LDN) on pain perception and quality of life in women
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion
- •for testing).
- •2. Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study
- •3. Signing the patient's informed and voluntary consent to participate in the study.
- •4. General health of the patient (WHO = 0-2).
- •5. Diagnosis of vulvodynia.
- •6. Negative drug test found at the visit randomization.
- •7. Documented correct cytology result from 3 years ago (before the visit screening).
- •8. 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.
- •9. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.
- •10. The ability to understand the principles of testing and operating electronic devices.
- •DETAILED CRITERIA (ASSIGNMENT TO A SUB-GROUP):
- •1. Fulfillment of one of the following criteria characteristic for individual groups:
- •i. Provoked vulvodynia: complaints only due to penetration. On the Marinoff scale = 1 point, on the scale (0-3) mostly penetration or no intercourse due to pain.
- •ii. Mixed vulvodynia: complaints that occur spontaneously and during penetration
- •iii. Spontaneous vulvodynia: complaints not related to an external factor (it can be cyclical, e.g. related to the menstrual cycle). Monthly pain intensity with daily follow-up NRS = 3, at least 10 days / 28 days.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •MAIN EXCLUSION CRITERIA
- •1. 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.
- •2. 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.
研究者
相似试验
进行中（未招募）
1 期
A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.EUCTR2019-000852-32-NLErasmusMC122
已完成
3 期
Efficacy of low-dose naloxone for the prevention of acute remifentanil-induced hyperalgesiaIRCT20101122005225N8Tehran University of Medical Sciences75
招募中
1 期
ow Dose Naltrexone for the treatment of long COVID-19long COVIDPost COVID-19 ConditionPost-acute sequelae of COVID-19Infection - Other infectious diseasesRespiratory - Other respiratory disorders / diseasesInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12623001042639Griffith University56
尚未招募
3 期
Evaluation of the effect of low-dose naltrexone in patients with Trigeminal Neuralgia and Chronic migraine patientsTrigeminal neuralgiaCondition 1: Trigeminal Neuralgia. Condition 2: Chronic Migraine.Chronic migraine without auraG50.0G43.7IRCT20171109037332N2Kerman University of Medical Sciences40
尚未招募
3 期
The effect of Ultra-low-dose Naloxone combined with Patient-Controlled-Analgesia Intravenous Morphine in Complex Spine Surgery: A Double blinded, Randomized Controlled TrialTCTR20221001003Faculty of Medicine, Chiang Mai University20