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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2011-006099-38
    Sponsor's Protocol Code Number:P-piller102
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2011-006099-38
    A.3Full title of the trial
    Effects of an antiandrogenic oral contraceptive on eating behaviour in women with
    bulimia – A randomized double blinded, placebo controlled study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of an antiandrogenic oral contraceptive on eating behaviour in women with
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberP-piller102
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN20110060
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT20110060
    A.5.3WHO Universal Trial Reference Number (UTRN)U2011-0060-9938
    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 SponsorKarolinska University Hospital
    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 supportKarolinska University Hospital
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointKvinnohälsan
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeS17176
    B.5.4Telephone number0046851773782
    B.5.5Fax number0046851774252
    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. name Yasmin
    D. of the Marketing Authorisation holderBayer
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 57-63-6
    D.3.9.4EV Substance CodeSUB07277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number003
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 67392-87-4
    D.3.9.4EV Substance CodeSUB06413MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typesynthetic hormones
    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
    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
    Bulimia nervosa is an eating disorder with a prevalence of about 2% in young women (Fairburn and Beglin, 1990). It is characterized by frequent binge eating episodes and the regular use of inappropriate compensatory behaviours, such as self-induced vomiting, laxative abuse or periods of fasting to prevent increase in body weight.
    E.1.1.1Medical condition in easily understood language
    Bulimia is an eating disorder. Those who suffer from the disease binge and compensates by throwing up food, laxatives, engage in excessive exercise and / or use of diet pills.
    Bulimia är en ätstörning. Den som lider av sjukdomen hetsäter och kompenserar genom att kräkas upp maten, använda laxermedel, ägna sig åt överdriven motion eller/och använda sig av bantningspreparat.
    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
    Primary objective: To evaluate the effect of three months treatment with drospirenon 3 mg and ethinylöstradiol 30 mikrogram compared to placebo on the change in bulimic behavior from baseline to the last month of treatment in women with bulimia.
    E.2.2Secondary objectives of the trial
    Secondary objective: To investigate correlations between the change in bulimic behaviour and the change in serum levels of sex hormones, hyperandrogenic symptoms and quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women with the diagnosis of bulimia nervosa or EDNOS of bulimic type according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria. Age18-40. BMI 18.5-30
    Women who are willing to use an OC for three months.Not having any medications including psychotropic drugs and any hormonal containing contraceptive. Willing to accept that they might have placebo treatment. Willing to use a non-hormonal method of birth control (e.g. diaphragm, condom, non-hormonal intrauterine device (IUD) or sterilization)
    E.4Principal exclusion criteria
    1.Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or a cerebrovascular accident
    2.History of migraine with focal neurological symptoms
    3.Diabetes mellitus
    4.Smoking > 10 cigarettes/day
    5.Hypertension, BP >140/90 mm Hg
    6.Hereditary or acquired predisposition for venous or arterial thrombosis
    7.Presence or history of severe hepatic disease as long as liver function values have not returned to normal
    8.Presence or history of liver tumours (benign or malignant)
    9.Known or suspected breast and gynecological malignancies
    10.Undiagnosed vaginal bleeding
    11.Known or suspected pregnancy
    12.Hypersensitivity to the active substances of the investigational product
    13.Renal insufficiency
    14.Use of hormonal contraception (OC, progestins, implantable contraceptives hormones, hormonal IUD, depot medroxuprogesterone acetate)
    15.Use of psychotropic drugs (antidepressants, anxiolytics and others)
    16.Spontaneous menstruation has not occurred following a delivery or abortion
    17.Breastfeeding or within three months after stopping breastfeeding prior to the start of the study medication
    18.Alcoholism or drug abuse
    19.Severe depression
    20.Psychotic disorders
    21.Increased risk of suicide
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of eating disorders and psychiatric comorbidity
    Bulimic behavior will be evaluated by a specialist trained psychologist before and at the last week of study treatment. The evaluation will be performed by the Stepwise quality assurance and clinical decision support system (Birgegård, Björck & Clinton, 2010). Stepwise consists of well validated and established instruments for diagnosing eating disorders and psychiatric comorbidity, structured interview (SEDI, SCID-I) as well as self-report instruments (EDE-Q, CIA, CPRS-S-A).

    Evaluation of acne and hirsutism
    Acne will be graded by the same investigator before and at the last week of study treatment using a standard method (Pillsbury et al 1956). Evaluation of body hair growth will be assessed by the same investigator using Ferriman Gallwey scoring at six different body sites (Ferriman and Gallwey, 1961).

    Life quality assessment
    The Swedish version of the Psychological General Well-Being Index (PGWB) (Dupuy 1984, Wiklund et al. 1992) will be used before and at the last week of study treatment for life quality assessment.

    Blood sampling
    Fasting venous blood samples are drawn at visit 2 and 3 between 8 am to 10 am for measurement of hormones and binding proteins. Serum will be separated after centrifugation and stored at -20°C until analyzed. The samples will be analyzed with respect to steroid hormones, binding proteins, metabolic and inflammatory factors.

    Sample size
    The sample size needed to detect a difference between groups with an α error of 0.05 and a  error of 0.20 is 50 completed subjects in each group, i.e. in total 100 patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three months treatment
    E.5.2Secondary end point(s)
    To investigate correlations between the change in bulimic behaviour and the change in serum levels of sex hormones, hyperandrogenic symptoms and quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months treatment
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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. 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 Yes
    E. description
    E.8.2.4Number of treatment arms in the trial1
    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
    The end of the trial is last visit.
    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 months
    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 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: 100
    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 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 state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 100
    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)
    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 Decision2012-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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