Oral Contraceptives and Economic Behaviour (P-piller101)

Karolinska University Hospital

Status: Unknown

Conditions: Female Contraception

Treatments: Drug: Oral contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT02257671

2010-020824-23

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Oral contraceptive

Active Comparator group

Description:

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

Treatment:

Drug: Oral contraceptive

Placebo

Placebo Comparator group

Description:

Oral placebo capsule daily during 11 weeks

Treatment:

Drug: Oral contraceptive