Effects of an antiandrogenic oral contraceptive on eating behaviour in women with bulimia

• Conditions: 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.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-006099-38-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-07
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified