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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003123-24-SE

Enrollment

Registered

2008-12-10

Start date

2009-01-21

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Neovletta Product Name: Neovletta Pharmaceutical Form: Tablet INN or Proposed INN: ethinylestradiol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess amygdala activation during oral contraceptive use (before reinstatement and during treatment);Secondary Objective: Compare amygdala activation between oral contraceptive and placebo. 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.	—

Measure

Time frame

Main Objective: Assess amygdala activation during oral contraceptive use (before reinstatement and during treatment);Secondary Objective: Compare amygdala activation between oral contraceptive and placebo. 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.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026