Patient with persistent somatoform pain disorder (F45.40 or F45.41) should be included into the study.
Conditions
Interventions
Trade Name: Tostran® 2%-Gel
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Current Sponsor code: Testosteron
Concentration unit: % percent
Concentration type: equal
Con
Sponsors
RWTH Aachen University/CTC-A
Eligibility
Sex/Gender
All
Inclusion 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: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The ICD-10 defines chronic pain due to only psychological factors (F45.40) and chronic pain due to psychological and somatic factors (F45.41). The phenotypes of both diagnoses are overlapping and it could be shown that patients with somatoform pain disorders have a decreased pain threshold compared to a control group. Both in male and female patients, there is data pointing towards a pain reducing capacity of additional testosterone treatment. Additionally it could be shown that sport and movement is able to alleviate pain symptoms. If this holds true for patients with somatoform pain disorder, is an open question. Therefore, the objective of the present study is to apply additional testosterone Treatment (= additional to "treatment as usual") to patients with somatoform pain disorder (F45.40 and F45.41) over the course of 8 weeks. During this course the effects of testosterone on the subjective pain threshold before and after endurance training should be investigated. ;Secondary Objective: As secondary objectives pain and endurance training associated prefrontal brain activation will be measured with near-infrared spectoscropy (NIRS). Additionally, the pain thershold before and after endurance training are investigated. Furthermore, the influence of testosterone on psychometric measures, like depressive, somatoform and daily subjective pain ratings, will be recorded. ;Primary end point(s): As primary end point the effect of testosterone on the subjective pain threshold should be investigated. For this aim the pain-thresholds are repeatedly recorded during the course of the study. In the end the height of the pain threshold in the intervention group (testosterone) will be compared to the "treatment as usual" group. ;Timepoint(s) of evaluation of this end point: The pain-threshold is measured directly in the beginning of the trial (day 0), then every 2 weeks until week 8. So, in total the pain-threshold is measured 5 times. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As secondary end points, the effect of testosterone treatment on the pain and endurance training related prefrontal brain activation will be investigated. Furthermore, the effect of testosterone on psychometric measures, like depressive, somatoform and daily subjective pain ratings, will be evaluated. For this aim the above described end points are compared between the interventional group (testosterone plus "treatment as usual") and the "treatment as usual" group.;Timepoint(s) of evaluation of this end point: The prefrontal brain activation in response to heat impulses near the prain-threshold and during the endurance training is measured on the same sessions as the subjective pain-threshold determinations and the endurance training . This will be done directly in the beginning of the trial, after 4 weeks and finally after 8 weeks. So, three times in total. The described psychometric measures will be administered directly at the start of the trial (day 0), followed by 4-week intervals, whereas the last administration will take place at the follow-up 12 weeks after study start. So, in total these psychometric measures will be administered four times. | — |
Countries
Germany
Contacts
Public ContactCTC-A
Clinical Trial Center Aachen (CTC-A)
Outcome results
None listed