Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-000048-32-DE
EUCTR2016-000048-32-DE
Active, not recruiting
Phase 1

Evaluation of the Therapeutic Effects of Testosterone on Pain Perception in case of Chronic Pain Disorder

RWTH Aachen University/CTC-A0 sites60 target enrollmentOctober 10, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPatient with persistent somatoform pain disorder (F45.40 or F45.41) should be included into the study.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsTostran® 2%-GelAndroFeme® 1

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patient with persistent somatoform pain disorder (F45.40 or F45.41) should be included into the study.
Sponsor
RWTH Aachen University/CTC-A
Enrollment
60
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 10, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
RWTH Aachen University/CTC-A

Eligibility Criteria

Inclusion Criteria

  • •1\. Diagnosis according to ICD\-10 F45\.40 and / or F45\.41
  • •2\. Age: 18\-64 years
  • •3\. Serum testosterone levels men: \<3 µg / l. Women: \<0\.06 µg/l
  • •4\. Patients in both groups should be asigned as outpatient (in the pain policlinic at the University Hospital Aachen) or inpatient (in the clinic of psychiatry, psychotherapy and psychosomatics at the RWTH Aachen) for at least 8 weeks presumably.
  • •5\. Full\-aged patients who are mentally and physically able to understand the meaning and scope of the study and to follow the study staff´s instructions
  • •6\. Signed written informed consent before study participation
  • •7\. For women: Regular (about yearly) outpatient gynecological examinations. Last cervical smear should be maximum one and a half year ago.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. In women:
  • •Breast cancer or other gynaecological tumors in medical history
  • •Pregnant and / or breast\-feeding women. Women of childbearing potential should be protected by an adequate contraception
  • •2\. In men:
  • •Prostate tumors, chronic prostatitis
  • •History of malignant prostate disease in the family, possible untreated sleep apnea, hematocrit above 50%.
  • •3\. Lack of capacity to consent in the study
  • •4\. Dementia
  • •5\. Schizophrenia
  • •6\. A study participation could pose an unacceptable risk at the judgement of the pincipal investigator due to a pre\-existing or concomitant disease or due to the general health state of the patient

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 4
Study of effects of testosterone replacement therapy in hypogonadal men with type 2 diabetes mellitus
CTRI/2019/09/021175Dr Ronak Gandhi
Active, not recruiting
Not Applicable
EFFECT OF TESTOSTERON THERAPY ON LOW URINARY TRACTmetabolic syndrome and BPH patients who will undergo simple prostatectomyMedDRA version: 14.1Level: LLTClassification code 10004447Term: Benign prostatic hypertrophySystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
EUCTR2012-003494-26-ITAZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Recruiting
Not Applicable
Result of testosterone (name of drug)in liver diseaseHealth Condition 1: K740- Hepatic fibrosis
CTRI/2019/08/021000Institute of Liver and Biliary Sciences
Completed
Phase 3
Effect of Testosterone Therapy Combined with Very Low Caloric Diet on Weight Loss and Weight Maintenance in Obese Men: A Randomized Controlled Trial
ACTRN12613000613707niversity of Melbourne100
Recruiting
Phase 3
Testosterone therapy for the treatment of nonalcoholic fatty liver disease
ACTRN12619000701123Austin Health120