euroanatomical and functional abnormalities in patients with aversive effects from oral contraceptives.

Conditions: Healthy women with previous adverse reaction to oral contraceptives
MedDRA version: 9.1Level: HLTClassification code 10016798Term: Fluctuating mood symptoms

Registration Number: EUCTR2008-003123-24-SE

Lead Sponsor: ppsala University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Prior report of adverse mood during OC use.
2. Otherwise healthy
3. Age 18 or older
4. Willing to use barrier method for contraception during the study.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Contraindications for OC use, as judged by investigator
2. Ongoing depressive or anxiety disorder
3. Ongoing use of CNS active treatment, including antidepressants, benzodiazepines.
4. Contraindications for MRI investigations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess amygdala activation during oral contraceptive use (before reinstatement and during treatment);Secondary Objective: Compare amygdala activation between oral contraceptive and placebo.<br>Compare amygdala activation between women with mood symptom recurrence and no mood symptom recurrence (placebo-responders vs. placebo-nonresponders and treatment-responders vs. treatment-nonresponders).;Primary end point(s): Amygdalaaktivation as measured by changes in blood oxygenation leved dependant imaging.

Secondary Outcome Measures