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    Summary
    EudraCT Number:2007-005315-26
    Sponsor's Protocol Code Number:A25165
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2008-10-15
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2007-005315-26
    A.3Full title of the trial
    Sperm Suppression and Contraceptive Protection provived by Norethisterone Enantate (NET-EN) combined with Testosterone Undecanoate (TU) in healthy men.
    A.4.1Sponsor's protocol code numberA25165
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCONRAD, Eastern Virgina Medical School
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Noristerat
    D.2.1.1.2Name of the Marketing Authorisation holderBayer House
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Nebido
    D.2.1.1.2Name of the Marketing Authorisation holderBayer House
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameTestosterone undecanoat
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    The proposed study is designed to evaluate whether the combination of a progestin, norethisterone
    enantate (NET-EN), and an androgen, testosterone undecanoate (TU), represents a safe and effective
    method of male fertility regulation.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065589
    E.1.2Term Male contraception
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is designed to address the following primary objectives:
    1. The rate of suppression of spermatogenesis induced by a regimen of NET-EN and TU
    administered every 8 weeks for up to 4 injection visits; and
    2. The level of contraceptive protection provided by the continued administration of NET-EN and
    TU every 8 weeks for an efficacy period of up to 56 weeks.
    E.2.2Secondary objectives of the trial
    Secondary objectives to be evaluated are as follows:
    1. Maintenance of suppression of spermatogenesis below the threshold criterion for contraception by
    the combined regimen, throughout the Efficacy Phase;
    2. Reversibility of the regimen as determined by the return of semen concentrations to ≥ 15
    million/ml or of total sperm numbers to ≥ 39 x 10^6, the lower reference limits (5th centile of the
    reference distribution) of a fertile population, as defined by current WHO recommendations
    3. Alterations in circulating concentrations of steroid and peptide hormones as a result of
    administration of this regimen;
    4. Safety, as monitored by reports of symptoms, examination findings, urine, and blood tests; and
    5. Hormonal regimen (method) acceptability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for male volunteers
    • Signed written Consent Form
    • Male healthy subjects
    • Ages 18-45 years, inclusive (or as allowed by local regulations for the lower age limit, but not
    less than 18 years)
    • Normal reproductive state demonstrated by:
    o sperm concentrations > 15 x 10^6 / ml or total sperm count of ≥ 39 x 10^6 in two semen
    samples with no gross abnormalities of sperm motility and morphology per investigator
    discretion
    o screening gonadotropin (LH and FSH) and testosterone levels should be within the
    centre’s normal ranges, however gonadotropin levels may fall below the lower limit of
    the normal ranges assuming the overall endocrine profile and semen parameters are
    indicative of a normal reproductive state
    • Body Mass Index (BMI) between 20 and 32 kg/m² (body weight in kilograms divided by body
    height in meters squared)
    • History and clinical examination without pathological findings relevant to the study including
    symptoms or signs of a sexually transmitted infection
    • Digital rectal examination of the prostate does not reveal any abnormal findings and PSA level
    is within normal range
    • Laboratory assay results do not suggest the presence of any illness
    • Sexually active with female partner, with a coital frequency of 2/week, on average
    • In a stable mutually monogamous relationship/partnership with the female partner for at least 1
    year within Visit A and intends to remain in the relationship for the course of the study
    • Willing to comply with the requirements of the study protocol
    • No desire for partner pregnancy within the next 2 years and willing to accept a low but unknown risk of pregnancy.

    Inclusion criteria for the female partners
    • Signed written Consent Form
    • Female healthy subjects
    • Ages 18-38 years, inclusive
    • No tubal ligation
    • Sexually active with male volunteer, with a coital frequency of 2/week, on average
    • Normal reproductive state demonstrated by:
    o regular menstrual cycles (no cycles that are shorter than 23 days or longer than 38 days)
    by volunteer history for the past three months. If recently used steroidal contraception
    see restrictions in Section 3.3.5, Screening/Enrollment Procedures, Enrollment Visit (S00).
    o medical and gynaecological history without findings suggestive of impaired fertility as
    judged by the P.I. (e.g. no history of pelvic inflammatory disease, endometriosis, use of hormonal contraception with the indication to regulate menses or
    complications resulting from any conception/pregnancy which may adversely affect
    future fertility)
    o no contraindication to pregnancy
    o no signs or symptoms of a sexually transmitted infection
    • In a stable mutually monogamous relationship/partnership with the male volunteer for at least 1
    year within Visit A and intends to remain in the relationship for the course of the study
    • Willing to comply with the requirements of the study protocol
    • Not pregnant at the time of entry to the Suppression Phase
    • No desire for pregnancy within the next 2 years and willing to accept a low but unknown risk of pregnancy
    E.4Principal exclusion criteria
    Exclusion criteria for the male volunteers:
    • Participation in another clinical trial within 30 days preceding the first drug administration, or
    simultaneous participation in another clinical trial
    • Institutionalized or imprisoned by order of the court
    • Competition in sports which use World Anti-Doping Agency (WADA) drug monitoring
    • History of or current prostate or testicular pathology (including varicocele that is visible or
    palpable without Valsalva maneuver) or male infertility
    • Serious organic or psychiatric disease suspected from history and/or clinical examination
    • Diseases (including tumors) that may be affected by testosterone use or that may affect the
    outcome of the study, e.g.:
    o prostate disease
    o past or present history, or family history, of thrombotic or embolic diseases
    o hypertension requiring therapy (BP >140/90 mm Hg)
    o diabetes mellitus requiring therapy
    o acute or chronic hepatic diseases
    o manifest renal diseases with renal dysfunction
    • Biochemical and/or hematological laboratory values outside normal ranges, unless the
    investigator confirms that the deviations are of no clinical relevance
    • Any indication of chronic use of illicit drugs or alcohol abuse
    • Use of any disallowed medications as listed in the Investigator’s Brochure or of any drug
    known to affect absorption, distribution, metabolism or excretion (ADME) of testosterone
    within the 30 days preceding the first administration of the test compounds
    • Use of oral anticoagulatory drugs (e.g., warfarin) within the 30 days preceding the first administration of the test compounds and during the study (aspirin is allowed)
    • Implantation of a sustained-action sex hormone within 8 months of Visit A
    • History of allergy to any component of the study drugs

    Exclusion criteria for the female partners:
    • Participation in any other clinical trial that would affect fertility
    • Use of DMPA 12 months prior to Visit A
    • Any indication of chronic use of illicit drugs or alcohol abuse
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints include:
    1. The proportion of male participants who are rendered azoospermic and/or severely
    oligozoospermic (sperm concentrations < 1 million/ml) at any point in the Suppression Phase; and
    2. 12-month contraceptive method failure rates.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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 No
    E.8.1.2Open No
    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 No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    see section 3.3.7 of the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-10-15. Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 400
    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)
    Men with persistently low sperm concentrations at month 12 of the recovery phase will continue to be followed and provided support and treatment on a case by case basis at the study’s expense until it is determined that they no longer need to be followed or until they decline further follow up. At these visits, only semen collections will be made. Analysis of recovery data will include only the first 12 months after entry into the Recovery Phase for all men.
    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 Decision2008-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-24
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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