E.1 Medical condition or disease under investigation |
E.1.1 | Medical 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. |
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E.1.1.1 | Medical 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.
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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. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.
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E.2.2 | Secondary 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary 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.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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The end of the trial is last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |