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    Summary
    EudraCT Number:2010-021195-28
    Sponsor's Protocol Code Number:BAY 98-7161 / 14835
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-04
    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 number2010-021195-28
    A.3Full title of the trial
    Single-center, randomized, placebo-controlled, double-blind, parallel group study to evaluate whether a single-dose of either 20 mg piroxicam, 40 mg piroxicam or 80 mg piroxicam shows an effect on ovulation after the onset of LH surge compared to placebo in healthy young women
    A.3.2Name or abbreviated title of the trial where available
    Effect of piroxicam on ovulation
    A.4.1Sponsor's protocol code numberBAY 98-7161 / 14835
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationBayer HealthCare AG
    B.5.2Functional name of contact pointCTP Team/Ref:"EU CTR"/
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstr 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.com
    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 Piroxicam
    D.2.1.1.2Name of the Marketing Authorisation holderHexal
    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.3.1Product namePiroxicam Hexal 2*10mg encapsulated tablets
    D.3.2Product code BAY l1902
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPiroxicam
    D.3.9.3Other descriptive namePiroxicam
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Emergency Contraception
    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
    To assess whether piroxicam has an effect on ovulation (delay or inhibition) when given after the onset of LH surge
    E.2.2Secondary objectives of the trial
    Describe the course of follicle sizes
    Investigate the course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
    Investigate the pharmacokinetics (PK) of piroxicam
    Investigate the correlation of serum concentrations of piroxicam and pharmacodynamic effects (PK/PD analysis), if applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed informed consent available before any study specific tests or procedures are performed
    •Healthy female subject
    •Age: 18 to 35 years (inclusive) at the first screening visit
    •Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit
    •Confirmation of the subject’s health insurance coverage prior to the first screening visit
    •Willingness to use non-hormonal methods of contraception during the study
    •Ability to understand and follow study-related instructions
    •Adequate venous access
    E.4Principal exclusion criteria
    •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
    •Known or suspected malignant tumors
    •Known or suspected benign tumors of the liver, pituitary, and adrenal gland
    •Known hypersensitivity to piroxicam, to other oxicam compounds, or to any of the excipients of the study medication
    •Known reactions in the form of bronchospasm, asthma, rhinitis, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past
    •History of any type of serious (allergic) reaction to medicinal products, particularly skin reactions such as erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis
    •Hypersensitivity to the active substance or skin reactions to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past
    •Unexplained haemopoietic or clotting disorders
    •Known current thyroid disorders which require treatment
    •Known diseases of the gastrointestinal tract that predispose to bleeding, such as ulcerative colitis, Crohn’s disease, or diverticulitis
    •History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation
    •Presence of frequent heartburn indicative of gastroesophageal reflux disease
    •Intolerance to lactose requiring strictly lactose-free diet and restriction to lactose-free oral medicines (hereditary galactose intolerance, galactose-glucose malabsorption, lactase deficiency)
    •History or presence of suffering from hay fever
    •Cerebrovascular or other active bleeds
    •Severe hepatic dysfunction or impaired renal function
    •Moderate or severe heart failure
    •Regular intake of medication other than hormonal contraceptives
    •Use of drugs affecting the synthesis of prostaglandins (especially NSAIDs) during the relevant time period (the relevant time period comprises: the day with the onset of LH surge including the two preceding days, plus the following days until ovulation is clearly observed – or until the next menstrual bleeding)
    •Use of short-acting hormonal contraceptives during the cycle preceding the pre-treatment cycle
    •Use of long-acting hormonal contraceptives within 40 weeks prior to the start of the pre-treatment cycle
    •Present use of an IUD releasing hormones; in case of recent use of an IUD releasing hormones, at least one complete menstrual cycle should have elapsed after its removal before starting the pre-treatment cycle (copper IUDs are acceptable)
    •Regular use of therapeutic or recreational drugs
    •Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks prior to the study drug administration
    •Suspicion of or known current drug or alcohol abuse
    •Heavy smokers with a daily consumption of > 25 cigarettes
    •Donation of whole blood or components of blood after signing the informed consent form
    •Systolic blood pressure below 95 or above 140 mmHg
    (after resting for at least 3 min in sitting position)
    •Diastolic blood pressure below 50 or above 90 mmHg
    (after resting for at least 3 min in sitting position)
    •Heart rate (HR) below 45 or above 95 beats / min
    (after resting for at least 3 min in sitting position)
    •Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure
    •Menstrual disorders suspicious of ovarian failure
    •Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU)
    •Undiagnosed vaginal bleeding
    •Less than 3 months since delivery, abortion, or lactation before the first screening examination
    •Time point “onset of LH surge” in the pre-treatment cycle not determinable
    •Time point “ovulation” in the pre-treatment cycle not determinable
    •Lacking suitability for frequent TVU examinations
    •Positive pregnancy test
    •Positive urine drug screening
    •Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
    •Clinically relevant deviations of the screened laboratory parameters from reference ranges (especially a ferritin value below 10 µg/L)
    •Exclusion periods from other studies or simultaneous participation in other clinical studies
    •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
    •Subject is in custody by order of an authority or a court of law
    •Previous assignment to treatment during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)
    •Close affiliation with the investigator or persons working at the study site
    •Subject is an employee of Bayer HealthCare or Bayer Schering Pharma AG
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the proportion of subjects with delay of ovulation (responder) or ovulation inhibition (responder).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 Information not present in EudraCT
    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
    The end of the study as a whole will be the date when the clean database is available.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 2011-01-04. 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 state64
    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)
    After the end of this study, further treatment is not necessary since only healthy subjects will be included in the study.
    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 Decision2011-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-29
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