Oral Contraceptives and Economic Behaviour (P-piller101)

The Influence of Oral Contraceptives on Mood, Sexuality and Economic Behavior

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.

Study Overview

• Status: Unknown
• Conditions: Female Contraception
• Intervention / Treatment: Drug: Oral contraceptive

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Department of Obstetrics and Gynecology, Karolinska University Hospital
    • Contact: Angelica L Hirschberg, Professor; Phone Number: +46 8 517 733 26; Email: angelica.linden-hirschberg@karolinska.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral contraceptive; oral dose of ethinylestradiol 0.03 mg + levonorgestrel 0.15 mg per day during 11 weeks	Drug: Oral contraceptive; Neovletta; Other Names: ethinylestradiol + levonorgestrel
Placebo Comparator: Placebo; Oral placebo capsule daily during 11 weeks	Drug: Oral contraceptive; Neovletta; Other Names: ethinylestradiol + levonorgestrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
economic behaviour	A modified dictator game will be used to measure altruistic behavior (Eckel and Grossman 1996). Each subject decides how to allocate money between herself and a charitable organisation. The size of the donation is our measure of altruism. Risk aversion is measured by a test where the subject makes several choices between a certain payoff and a 50/50 gamble to win a certain amount of money (Dohmen et al 2005). Competitiveness is defined as the extent to which women choose to compete in a task which involves solving as many simple mathematical exercises as possible during three minutes (Niederle and Vesterlund 2007).	11 weeks
sexual behaviour	Sexual function will be assessed by the validated instruments Sexual Activity Log (SAL) (Derogatis et al 2004), Profile of Female Sexual Function (PFSF) (McHorney et al 2004, Derogatis et al 2004) and Personal Distress Scale (PDS, past 30 days) (Derogatis et al 2004, Leiblum et al 2006). The women are answering the questionnaires, which are all computerized, at the Women´s Health Research Unit.	baseline to 11 weeks
mood	Mood and health-related quality of life will be assessed by the Beck Depression Inventory (BDI) test (Lightfoot and Oliver 1985) and the Psychological General Well-Being Index (PGWB) (Dupuy 1984, Wiklund et al 1992).	baseline to 11 weeks

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Angelica L Hirschberg, Professor, Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 28, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2014
• Last Update Submitted That Met QC Criteria: October 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Levonorgestrel; Contraceptive Agents; Ethinyl Estradiol; Contraceptives, Oral
• Other Study ID Numbers: 2010-020824-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No