Oral Contraceptives and Economic Behaviour

Female Contraception Clinical Trial

— P-piller101  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02257671
• Other study ID #: 2010-020824-23
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2014
• Last updated: October 2, 2014
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Karolinska University Hospital
• Contact: Angelica L Hirschberg, Professor
• Phone: +46 8 517 733 26
• Email: angelica.linden-hirschberg[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Contraception

Intervention

Drug:
• Oral contraceptive
Neovletta

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and Gynecology, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes