Does Testposterone improve the Pain Perception of Patients with Chronic Pain?

Phase 1

• Conditions: Patient 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]

• Registration Number: EUCTR2016-000048-32-DE
• Lead Sponsor: RWTH Aachen University/CTC-A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-10
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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%.
General:
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
7. There is a life expectancy of less than six months
8. There is a current or pre-existing medical disease or treatment that might influence the evaluation of the study
9. The patient has received a study drug in another study within the last 30 days
10. Simultaneous participation in another clinical intervention study
11. Expected missing compliance
12. Alcohol or drug abuse
13. The patient is placed in an institution due to governmental or judicial authorities.
14. Patients who are in a dependent relationship or employment relationship with the sponsor, investigator or his deputy
15. Kidney dysfunction or essential cardiac or hepatic pre-existing conditions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified