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Oral Contraceptives and Economic Behaviour

NCT ID: NCT02257671

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-12-31

Brief Summary

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The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood, sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400 healthy women will be randomized to OC or placebo for a period of three months. Before and at the end of treatment, mood and sexuality will be assessed by validated instruments. At the end of treatment, each woman will participate in behavioral experiments testing self-confidence, risk taking and altruism. The current project could fill the gap of ignorance about causal effects of OCs on mood, sexuality and behavior. The results might improve current practice as regards information about OCs, choice of hormonal contraceptive, regimen and duration of use. As a consequence, this could lead to reduced discontinuation rate, fewer unintended pregnancies and abortions. The project will contribute to an overall improvement in women's reproductive health.

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Detailed Description

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Conditions

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Female Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral contraceptive

oral dose of ethinylestradiol 0.03 mg + levonorgestrel 0.15 mg per day during 11 weeks

Group Type ACTIVE_COMPARATOR

Oral contraceptive

Intervention Type DRUG

Neovletta

Placebo

Oral placebo capsule daily during 11 weeks

Group Type PLACEBO_COMPARATOR

Oral contraceptive

Intervention Type DRUG

Neovletta

Interventions

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Oral contraceptive

Neovletta

Intervention Type DRUG

Other Intervention Names

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ethinylestradiol + levonorgestrel

Eligibility Criteria

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Inclusion Criteria

* Healthy young women, aged 18-35 years, BMI 19-30

Exclusion Criteria

* Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and estrogen/gestagen therapy the last three months
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Angelica Lindén Hirschberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angelica L Hirschberg, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden

Locations

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Department of Obstetrics and Gynecology, Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Angelica L Hirschberg, Professor

Role: CONTACT

[email protected]
+46 8 517 733 26

Facility Contacts

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Angelica L Hirschberg, Professor

Role: primary

[email protected]
+46 8 517 733 26

Other Identifiers

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2010-020824-23

Identifier Type: -

Identifier Source: org_study_id

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