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.
Conditions
Interventions
Trade Name: Yasmin
Pharmaceutical Form: Capsule
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 003-
INN o
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 a error of 0.05 and a ? error of 0.20 is 50 completed subjects in each group, i.e. in total 100 patients. ;Timepoint(s) of evaluation of this end point: Three months treatment ;Main Objective: 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. ;Secondary Obje | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: Three months treatment | — |
Countries
Sweden
Contacts
Public ContactKvinnohälsan
Karolinska University Hospital
Outcome results
None listed