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A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial

Journal article
Authors N. Zethraeus
A. Dreber
Eva Ranehill
L. Blomberg
F. Labrie
Bo von Schoultz
M. Johannesson
A. L. Hirschberg
Published in Fertility and Sterility
Volume 107
Issue 5
Pages 1238-1245
ISSN 0015-0282
Publication year 2017
Published at Department of Economics
Pages 1238-1245
Language en
Links https://doi.org/10.1016/j.fertnster...
Keywords Depression, oral contraceptives, quality of life, randomized clinical trial, well-being, sexual function, mood, symptoms, allopregnanolone, discontinuation, levonorgestrel, testosterone, drospirenone, improvement, depression, Obstetrics & Gynecology, Reproductive Biology
Subject categories Obstetrics and women's diseases

Abstract

Objective: To determine whether there is a causal effect of oral contraceptive (OC) treatment on general well-being and depressed mood in healthy women. Patient(s): Three hundred and forty healthy women aged 18-35 years randomized to treatment, of whom 332 completed the data collection at follow-up evaluation. Intervention(s): A combined OC (150 mg levonorgestrel and 30 mu g ethinylestradiol) or placebo for 3 months of treatment. Main Outcome Measure(s): Primary outcome measures: global score of Psychological General Well-Being Index (PGWBI) and the Beck Depression Inventory (BDI); secondary outcome measures: six separate dimensions of the PGWBI. Result(s): The OC treatment statistically significantly decreased general well-being compared with placebo -4.12 (95% CI, -7.18 to -1.06). Furthermore, OC decreased the following PGWBI dimensions compared with placebo: positive well-being -3.90 (95% CI, -7.78 to -0.01), self-control - 6.63 (95% CI, -11.20 to -2.06), and vitality -6.84 (95% CI, -10.80 to -2.88). The effect of OC on depressive symptoms and on the PGWBI dimension depressed mood were not statistically significant. Conclusion(s): This study demonstrates a statistically significant reduction in general well-being by a first-choice OC in comparison with placebo in healthy women. We found no statistically significant effects on depressive symptoms. A reduction in general well-being should be of clinical importance. (C) 2017 by American Society for Reproductive Medicine.

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