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    Summary
    EudraCT Number:2006-006633-41
    Sponsor's Protocol Code Number:310723
    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:2007-03-13
    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 number2006-006633-41
    A.3Full title of the trial
    Monocenter, open-label, randomized study to determine the ovulation inhibitory effect of the combined oral contraceptives SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release medicinal product) and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), applied for two treatment cycles to 60 healthy female volunteers
    A.3.2Name or abbreviated title of the trial where available
    Valette low ovulation inhibition
    A.4.1Sponsor's protocol code number310723
    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 Schering Pharma 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 nameValette low
    D.3.2Product code SH T04769G
    D.3.4Pharmaceutical form Modified-release tablet
    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 INNEthinylestradiol
    D.3.9.1CAS number 57636
    D.3.9.2Current sponsor codeZK 4944
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.015
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDienogest
    D.3.9.1CAS number 65928-58-7
    D.3.9.2Current sponsor codeZK 37659
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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 Yes
    D.2.1.1.1Trade name Valette
    D.2.1.1.2Name of the Marketing Authorisation holderJenapharm GmbH & Co. KG
    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 nameValette
    D.3.2Product code SH D00659AF
    D.3.4Pharmaceutical form Coated tablet
    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 INNEthinylestradiol
    D.3.9.1CAS number 57636
    D.3.9.2Current sponsor codeZK 4944
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDienogest
    D.3.9.1CAS number 65928-58-7
    D.3.9.2Current sponsor codeZK 37659
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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
    The aim of this monocenter, open-label, randomized study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.15 mg Ethinylestradiol and
    1.5 mg Dienogest in a modified release film-coated tablet) and to collect supplementary data regarding the ovulation inhibitory effect of the well-established COC Valette SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest).
    The intended indication for the product under development is the hormonal contraception.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030970
    E.1.2Term Oral 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 aim of the study is to determine the ovulation inhibitory effect of the COC
    SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release film-coated tablet) and to collect supplementary data regarding the ovulation inhibitory effect of SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest) in treatment cycle 2.
    Ovulation inhibition will be assessed by TVU of the leading follicle diameter and by analysis of serum hormone levels (estradiol, progesterone). Ovarian activity will be classified according to Hoogland & Skouby (1993). A score of < 6 will be regarded as inhibition of ovulation.
    E.2.2Secondary objectives of the trial
    - Grading of ovarian activity according to Hoogland & Skouby (1993)
    - Follicle size (leading follicle)
    - Endogenous hormones (estradiol, progesterone, FSH, LH)
    - Assessment of cervical mucus according to Insler (1972)
    - Levels of DHEA-S, SHBG, and testosterone (only in volunteers receiving SH D00659AF)
    - Pharmacokinetic evaluation at steady-state (only in volunteers receiving the test product SH T04769G)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - healthy female volunteers aged between 18 and 35 years (inclusive), smokers not older than 30 years (inclusive) at inclusion
    - follicular diameter >= 15 mm before Visit 6 / admission to treatment or observed ovulation during pre-treatment cycle, absence of premature follicular ripening
    - non-suspicious cervical smear taken at Screening
    - signed and dated informed consent
    E.4Principal exclusion criteria
    - Pregnancy, lactation (less than 3 cycles following delivery, abortion, or lactation before start of pre-treatment cycle)
    - Known hypersensitivity to any ingredients of the study medication, e.g. patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
    - Any known diseases or conditions that compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
    - Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results
    - Uncontrolled thyroid disorders
    - Clinically significant depression (current or in the last year)
    - Abnormal, clinically significant findings which, according to the assessment of the investigator, may worsen under hormonal treatment (e.g., pemphigoid gestationis during a previous pregnancy; middle-ear deafness (otosclerosis); sydenham chorea, porphyria, systemic lupus erythematodes, hemolytic uremic syndrome)
    - Laboratory values outside inclusion range at Screening
    - Participation in another clinical study or administration of an investigational drug within 1 month prior to study entry (Visit 1)
    - Operations scheduled in the study period
    - Liver diseases: acute and chronic progressive liver diseases, e.g., disturbances of the bilirubin excretion of the bile (Dubin-Johnson and Rotor syndromes) , disturbances of the bile secretion, disturbances in the bile flow, idiopathic icterus or pruritus during a previous pregnancy or estrogen-progestogen treatment.
    Presence or history of liver tumors (benign or malignant)
    Existing or previous hepatic disease as long as liver function values have not returned to normal. There should be an interval of at least 3 months between the start of study medication intake and the return of liver function values to normal.
    - Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
    - Vascular diseases and coagulation disorders:
    Existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), presence or history of prodromi of a thrombosis (e.g., transient ischemic attack, angina pectoris), existing or previous cerebrovascular accident, as well as any condition that could increase the risk of any of the above, e.g., hereditary or acquired predisposition for venous or arterial thrombosis, such as APC-resistance, Antithrombin III (AT-III) deficiency, Protein-C and/or Protein-S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant), any venous thromboembolic event that occurred in a close relative at a younger age (≤ 50 years), specific heart diseases (e.g., valvular heart disease, atrial fibrillation) cardiac dysfunction (NYHA I-IV), pronounced varicosis veins, mild varicosis veins or previous phlebitis in combination with other risk factors
    - Uncontrolled arterial hypertension (confirmed systolic blood pressure > 140 mmHg or confirmed diastolic blood pressure > 90 mmHg)
    - Known diabetes mellitus
    - Sickle-cell anemia
    - Known severe disturbances of lipid metabolism
    - Known or suspected malignant or premalignant steroid-hormone dependent diseases (e.g., endometrial cancer, breast cancer), also a history thereof. Volunteers with other malignancies / premalignancies may be included if they have been recurrence-free for at least 5 years.
    - Other diseases: migraine with neurologic symptoms (complicated migraine), undiagnosed vaginal bleeding, manifest kidney disease with impaired renal function, worsening of epilepsy or chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) under hormonal treatment
    - Alcohol, drug, or medicine abuse (e.g., laxatives)
    - Prohibited concomitant medication:
    Additional sex steroids (excluding topical use of Progestogel®); antiepileptics, hypnotics and sedatives; tuberculostatics; oral antimycotics; HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors; modafinil, cyclosporine, lamotrigine; products containing the herbal remedy St. John's wort (Hypericum perforatum); and continuous systemic use of antibiotics
    - Sex hormones prior to start of treatment:
    Oral, transdermal, intrauterine, or intravaginal administration within 1 cycle prior to start of pre-treatment cycle
    Use of implants within 1 month prior to Visit 1
    Use of long-acting progestins within 6 months prior to Visit 1
    - Use of intrauterine devices without hormone release within1 cycle prior to start of treatment.
    - Considerable overweight (body mass index > 30)
    - Volunteer is a dependent person, e.g., a relative, family member, or member of the investigator’s staff.
    - Volunteer is in custody by order of an authority or a court of law
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable of this study is ovulation inhibition in Treatment Cycle 2 (no/yes), as assessed by ultrasonographic monitoring (TVU) of the leading follicle diameter, and by analysis of serum hormone levels (estradiol, progesterone).
    Ovarian activity will be classified according to Hoogland & Skouby (1993). A score of < 6 will be regarded as inhibition of ovulation.
    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 Yes
    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 Yes
    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 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) Yes
    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 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
    For a single volunteer, the study will be concluded on the day of her last visit (including last additional visit, if applicable) provided the results of the safety laoratory tests are available, evaluable, and consistent with the criteria defined. In other cases, the test has to be repeated, postponing therefore the End of Study.
    For the whole study, the End of Study is defined as last-volunteer-last-visit (including last additional visit, if applicable).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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
    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 Decision2007-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-03
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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