title: 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: OBJECTIVE
  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.
authors.affiliation: a Zuyderland Medical Centre , Heerlen , Netherlands.
authors.forename: Frans J M E
authors.initials: FJ
authors.lastname: Roumen
authors.affiliation: b Pantarhei Bioscience , Zeist , Netherlands.
authors.forename: Yvette
authors.initials: Y
authors.lastname: Zimmerman
authors.affiliation: c VieCuri Medical Centre , Venlo , Netherlands.
authors.forename: Annemieke
authors.initials: A
authors.lastname: van Wijck
authors.affiliation: d Leiden University Medical Centre , Leiden , Netherlands.
authors.forename: Moniek M
authors.initials: MM
authors.lastname: Ter Kuile
authors.affiliation: e KU Leuven - University of Leuven , Leuven , Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Onghena
authors.affiliation: b Pantarhei Bioscience , Zeist , Netherlands.
authors.forename: Herjan J T
authors.initials: HJ
authors.lastname: Coelingh Bennink
mesh_terms: D000339:Affect / Q000187:drug effects*; D000736:Androstenes / Q000008:administration & dosage*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D003687:Dehydroepiandrosterone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D019964:Mood Disorders / Q000517:prevention & control*; D010865:Pilot Projects; D011788:Quality of Life
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D003687:Dehydroepiandrosterone
keywords: Androgen; androgen supplementation; combined oral contraceptive; mood; mood disturbance; oral contraceptive pill