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

doi:10.1016/j.fertnstert.2017.02.120

Fertility and Sterility

Volume 107, Issue 5, May 2017, Pages 1238-1245

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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.

Key Words

Depression

oral contraceptives

quality of life

randomized clinical trial

well-being

Cited by (0)

: N.Z. has nothing to disclose. A.D. has nothing to disclose. E.R. has nothing to disclose. L.B. has nothing to disclose. F.L. has received personal fees from EndoCeutics Inc. B.V.S. has nothing to disclose. M.J. has nothing to disclose. A.L.H. has nothing to disclose.

: Supported by research grants from Jan Wallander and Tom Hedelius Foundation (P2010–0133:1, P2012–0002:1, and P2013–0156:1), Knut and Alice Wallenberg Foundation (Wallenberg Academy Fellows grant to A. Dreber), Swedish Council for Working Life and Social Research (2006–1623), the Swiss National Science Foundation (100010–149451), the Swedish Research Council (20324), Karolinska Institutet, and the regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet (20130313). The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. All authors had full access to all the data in the study and were responsible for the decision to submit for publication.

: N.Z., A.D., and E.R. should be considered similar in author order.