Mood disturbances during combined oral contraceptive use and the effect of androgen supplementation. Results of a double-blind, placebo-controlled, single-case alternation design pilot study

Abstract Objectives: To evaluate the effect of androgen supplementation in healthy combined oral contraceptive (COC) users who experience mood disturbances during COC-use only. Methods: Six women with mood disturbances during COC-use only, received COC with co-treatment of 50 mg dehydroepiandrosterone (DHEA) during three cycles and placebo during another three cycles in an individualized random order. Daily mood rating was measured by a single item: ‘In what kind of mood have you been in the past 24 h?’ The results were analysed using a randomisation test for single-case experimental designs. Results: The p values for the alternation design randomisation tests on the raw data of the six healthy individuals varied between 0.21 and 1, indicating that the average daily mood ratings of the active treatment DHEA are not statistically significantly larger than the average daily mood ratings of placebo. The combined p value of the subjects using a DRSP-containing pill was 0.97, and of the subjects using an LNG-containing pill was 0.65, indicating no statistically significant treatment effect for any of the pill types. Conclusions: In this single-case alternation design study, concomitant treatment with DHEA for intermittent periods of 4 weeks did not result in improvement of mood disturbances related to COC-use, but had also no side-effects.

[1]  Negin Golrezaei Users , 2018, Social Media Data Mining and Analytics.

[2]  L. Kessing,et al.  Association of Hormonal Contraception With Depression. , 2016, JAMA psychiatry.

[3]  J. Foidart,et al.  Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects. , 2015, Contraception.

[4]  J. Foidart,et al.  Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: I. Endocrine effects. , 2015, Contraception.

[5]  M. Eijkemans,et al.  The effect of combined oral contraception on testosterone levels in healthy women: a systematic review and meta-analysis , 2013, Human reproduction update.

[6]  Mats Fredrikson,et al.  Oral contraceptive use changes brain activity and mood in women with previous negative affect on the pill—A double-blinded, placebo-controlled randomized trial of a levonorgestrel-containing combined oral contraceptive , 2013, Psychoneuroendocrinology.

[7]  V. Rickert,et al.  Influence of depressed mood and psychological stress symptoms on perceived oral contraceptive side effects and discontinuation in young minority women. , 2012, Contraception.

[8]  A. Buysse,et al.  Relation of androgen receptor sensitivity and mood to sexual desire in hormonal contraception users. , 2012, Contraception.

[9]  Birgitta Segebladh,et al.  Adverse mood symptoms with oral contraceptives , 2012, Acta obstetricia et gynecologica Scandinavica.

[10]  Patrick Onghena,et al.  An R package for single-case randomization tests , 2008, Behavior research methods.

[11]  H. Doll,et al.  Does oral contraceptive-induced reduction in free testosterone adversely affect the sexuality or mood of women? , 2007, Psychoneuroendocrinology.

[12]  J. Vandenbroucke [The N-of-1 trial: the ideal study design that is underused]. , 2006, Nederlands tijdschrift voor geneeskunde.

[13]  J. Bancroft The endocrinology of sexual arousal. , 2005, The Journal of endocrinology.

[14]  D. Mazmanian,et al.  To what extent do oral contraceptives influence mood and affect? , 2002, Journal of affective disorders.

[15]  J. Shifren Androgen deficiency in the oophorectomized woman. , 2002, Fertility and sterility.

[16]  H. Burger,et al.  Female androgen insufficiency: the Princeton consensus statement on definition, classification, and assessment. , 2002, Fertility and sterility.

[17]  L. Kahn,et al.  Oral contraceptives and mood , 2001, Expert opinion on pharmacotherapy.

[18]  S. Sanders,et al.  A prospective study of the effects of oral contraceptives on sexuality and well-being and their relationship to discontinuation. , 2001, Contraception.

[19]  E S Edgington,et al.  Randomization tests for restricted alternating treatments designs. , 1994, Behaviour research and therapy.

[20]  E. Noble,et al.  The menstrual cycle: a double-blind study of symptoms, mood and behavior, and biochemical variables using enovid and placebo. , 1971 .

[21]  E. Noble,et al.  The Menstrual Cycle: A Double‐Blind Study of Symptoms, Mood and Behavior, and Biochemical Variables Using Enovid and Placebo , 1971, Psychosomatic medicine.

[22]  Patrick Onghena,et al.  Journal of Modern Applied Statistical Methods the Single-case Data Analysis Package: Analysing Single-case Experiments with R Software Statistical Software Applications and Review: the Single-case Data Analysis Package: Analysing Single-case Experiments with R Software Patrick Onghena , 2022 .

[23]  Eugene S. Edgington,et al.  Randomization Tests , 2011, International Encyclopedia of Statistical Science.

[24]  S. Legrain,et al.  Pharmacology And Therapeutic Effects of Dehydroepiandrosterone In Older Subjects , 2003, Drugs & aging.