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    Summary
    EudraCT Number:2016-000048-32
    Sponsor's Protocol Code Number:15-062
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-10-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-000048-32
    A.3Full title of the trial
    Evaluation of the Therapeutic Effects of Testosterone on Pain Perception in case of Chronic Pain Disorder
    Evaluation des Therapieeffekts von Testosteron auf die Schmerzwahrnehmung bei Anhaltender Schmerzstörung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does Testposterone improve the Pain Perception of Patients with Chronic Pain?
    Verbessert Testosteron die Schmerzwahrnehmung bei Patienten mit Anhaltender Schmerzstörung?
    A.4.1Sponsor's protocol code number15-062
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRWTH Aachen University/CTC-A
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical faculty of RWTH Aachen University (Start Förderung)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Center Aachen (CTC-A)
    B.5.2Functional name of contact pointCTC-A
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstraße 30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number0049024180 80092
    B.5.5Fax number00490241 80 33 35849
    B.5.6E-mailsisfort@ukaachen.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tostran® 2%-Gel
    D.2.1.1.2Name of the Marketing Authorisation holderProStrakan, Galashiels, United Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number 58-22-0
    D.3.9.2Current sponsor codeTestosteron
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name AndroFeme® 1 Cream containing 1% w/v (10mg/mL) Testosterone B.P (17-β- Hydroxyandrost-4-en-3-one)
    D.2.1.1.2Name of the Marketing Authorisation holderLawley Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number 58-22-0
    D.3.9.2Current sponsor codeTestosteron
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient with persistent somatoform pain disorder (F45.40 or F45.41) should be included into the study.
    Patienten mit einer anhaltenden somatoformen Schmerzstörung (F45.40 oder F45.41) sollen in die Studie eingeschlossen werden.
    E.1.1.1Medical condition in easily understood language
    Patients suffering from long lasting pain, that could not effecively be treated/cured and where no single medical causes can explain the condition, should be included into the study.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(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.
    E.5.2Secondary 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.
    E.5.2.1Timepoint(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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Treatment (testosterone) is compared to treatment as usual. Assignment to group is randomised.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-26
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