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    Summary
    EudraCT Number:2010-021255-81
    Sponsor's Protocol Code Number: BAY 86-5016/15264
    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:2010-08-20
    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 number2010-021255-81
    A.3Full title of the trial
    Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles
    A.3.2Name or abbreviated title of the trial where available
    Inhibition of ovulation and pharmacokinetic study of 3 transdermal EE and GSD formulations
    A.4.1Sponsor's protocol code number BAY 86-5016/15264
    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 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 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 No
    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 nameTreatment A
    D.3.2Product code material no. 80876395
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.55
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 60282-87-3
    D.3.9.3Other descriptive nameGESTODENE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.1
    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 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 No
    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 nameTreatment B
    D.3.2Product code material no. 82952080
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.35
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 60282-87-3
    D.3.9.3Other descriptive nameGESTODENE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.67
    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 No
    D.IMP: 3
    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 No
    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 nameTreatment C
    D.3.2Product code Materialno. 82952099
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.275
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 60282-87-3
    D.3.9.3Other descriptive nameGESTODENE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.05
    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 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
    Prevention of Pregnancy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10060346
    E.1.2Term Transdermal 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 primary objective of this study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 after dermal application of 3 different patch formulations containing ethinylestradiol (EE) / gestodene (GSD) for 3 treatment cycles
    E.2.2Secondary objectives of the trial
    •Course of gonadotropins (FSH, LH) and ovarian steroids (E2, P)
    •Endometrial thickness
    •Pharmacokinetics of EE, GSD and SHBG
    •Follicle size
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Healthy female subject
    2.Age: 18 to 35 years (inclusive) at the first screening visit
    3.Body mass index (BMI): ≥ 18 kg/m²
    4.Ability to understand and follow study-related instructions
    5.Willingness to use non-hormonal methods of contraception during the entire study
    6.Signed informed consent before any study specific tests or procedures are done
    7.Confirmation of the subject’s health insurance coverage prior to the first screening examination
    E.4Principal exclusion criteria
    1.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
    2.Known or suspected malignant tumors (including after treatment)
    3.Known or suspected benign tumors of the liver, pituitary and adrenal gland (including after treatment)
    4.Known or suspected liver disorders, including disturbances of bilirubin metabolism (e.g. Dubin-Johnson and Rotor syndromes) and bile secretion/flow (cholestasis, also history of it)
    5.Conditions/diseases known to occur or deteriorate with both pregnancy and COC use.
    6.Presence or history of pancreatitis
    7.Presence or history of venous or arterial thrombotic/thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischaemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g. a family history indicating hereditary predisposition
    8.Diseases associated with adverse vascular events (e.g. diabetes mellitus, chronic inflammatory diseases like Crohn’s disease or colitis ulcerosa, severe disorders of lipid metabolism, sickle-cell anemia)
    9.Severe renal insufficiency or acute renal failure
    14.Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria)
    16.Regular use of medicines other than contraceptives
    17.Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before the first study drug administration
    18.Use of sex hormones (oral, transdermal, intravaginal) during the cycle preceding the pre-treatment cycle
    19.Use of any long-acting injectable or implant hormonal therapy within 40 weeks prior to the first study drug administration
    20.Use of an intra-uterine system (IUS) releasing hormones during the cycle preceding the pre-treatment cycle (non-hormonal intra-uterine devices are acceptable)
    22.Smokers: at the age of 18 to 30 years inclusive (at first screening visit) with a daily consumption of > 10 cigarettes or at the age of 31 to 35 years inclusive (at first screening visit); former smokers who have stopped smoking at least 3 months prior to the first screening visit may be included
    23.Donation of blood or plasmapheresis after signing the informed consent
    24.Systolic blood pressure below 90 or above 140 mmHg (after at least 3 min in sitting position)
    25.Diastolic blood pressure below 45 or above 90 mmHg (after at least 3 min in sitting position)
    27.Clinically relevant findings in the physical examination (e.g. pronounced varicosis, thrombophlebitis, evidence of peripheral circulatory disturbances, skin abnormalities in the application area)
    28.Clinically relevant findings in the gynecological examination including transvaginal ultrasound
    29.Cervical cytological smear classified higher than II according to Papanicolaou (grading I - V)
    30.Genital bleeding of unknown origin
    31.Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea)
    32.Delivery, abortion or lactation less than 3 months before the first screening examination
    33.Positive urine pregnancy test
    34.Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
    35.Clinically relevant deviations of the screened laboratory parameters from reference ranges
    36.Positive urine drug screen
    37.Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)
    38.Subject is in custody by order of an authority or a court of law
    39.Close affiliation with the investigator (e.g. a close relative) or a dependent person (e.g. employee or student of the study center)
    40.Prolonged immobilization, major surgery, any surgery to the legs, or major trauma unless complete remobilization is achieved at least 4 weeks before first screening examination
    41.Scheduled major surgery after signing the informed consent and up to 6 weeks after the end of treatment
    42.Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
    45.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
    E.5 End points
    E.5.1Primary end point(s)
    The primary pharmacodynamic variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    As for this study the important results (i. e. pharmacokinetics) will be analyzed after LPLV, the end of the study as a whole will be the date when the clean data base 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 months12
    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 months12
    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 2010-08-20. 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 state174
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 174
    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)
    not necessary - Healthy volunteers see study protocol
    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 Decision2010-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-06
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