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Fertil Steril. 2017 May;107(5):1238-1245. doi: 10.1016/j.fertnstert.2017.02.120. Epub 2017 Apr 19.

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

Author information

1
Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
2
Department of Economics, Stockholm School of Economics, Stockholm, Sweden.
3
Center for Economic Research, ETH, Zurich, Switzerland; Department of Economics, University of Gothenburg, Gothenburg, Sweden.
4
Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
5
Laval University, Quebec City, Montreal, Canada.
6
Department of Economics, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
7
Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden. Electronic address: angelica.linden-hirschberg@sll.se.

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.

DESIGN:

Double-blind, randomized, and placebo-controlled trial.

SETTING:

University hospital.

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 μg levonorgestrel and 30 μg 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.

KEYWORDS:

Depression; oral contraceptives; quality of life; randomized clinical trial; well-being

[Indexed for MEDLINE]

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