Oral Contraceptives and Economic Behaviour

NCT02257671 | Unknown

• 1 other identifier: 2010-020824-23
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Contraception

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Oral contraceptive

ACTIVE COMPARATOR

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

Drug: Oral contraceptive

Placebo

PLACEBO COMPARATOR

Oral placebo capsule daily during 11 weeks

Drug: Oral contraceptive

Interventions

Oral contraceptive DRUG

Neovletta

Also known as: ethinylestradiol + levonorgestrel

Oral contraceptive; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and estrogen/gestagen therapy the last three months

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, Karolinska University Hospital

Stockholm, 171 76, Sweden

RECRUITING

MeSH Terms

Interventions

Contraceptives, Oral; Ethinyl Estradiol; Levonorgestrel

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes

Study Officials

• Angelica L Hirschberg, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica L Hirschberg, Professor

CONTACT

+46 8 517 733 26; angelica.linden-hirschberg@karolinska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: October 6, 2014
• Study Start: February 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 6, 2014

Record last verified: 2014-10

Locations

SE (1)