title: Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects.
abstract: OBJECTIVE
  Combined oral contraceptives (COCs) decrease androgen levels, including testosterone (T), which may be associated with sexual dysfunction and mood complaints in some women. We have shown that 'co-administration' of dehydroepiandrosterone (DHEA) to a drospirenone (DRSP)-containing COC restored total T levels to baseline and free T levels by 47%. Here we describe the effects on sexual function, mood and quality of life of such an intervention.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled study in 99 healthy COC starters. A COC containing 30 mcg ethinylestradiol (EE) and 3 mg DRSP was used for three cycles, followed by six cycles of the same COC combined with 50 mg/day DHEA or placebo. Subjects completed the Moos Menstrual Distress Questionnaire (MDQ), the McCoy Female Sexuality Questionnaire and the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Safety and tolerability, including effects on skin, were evaluated.
  
  
  RESULTS
  The addition of DHEA induced small but significant improvements compared to placebo in the MDQ score for autonomic reactions during the menstrual (-2.0 vs. 0.71; p=0.05) and the premenstrual phase (-3.1 vs. 2.9; p=0.01) and for behavior during the intermenstrual phase (-1.4 vs. 3.6; p=0.02). A significant difference was found in the MDQ score for arousal during the premenstrual phase in favor of placebo (-5.0 vs. 1.0; p=0.01). There were no statistically significant differences between groups for the MSFQ and Q-LES-Q scores. DHEA 'co-administration' resulted in an acceptable safety profile. DHEA negated the beneficial effect of the COC on acne according to the subjects' self-assessment.
  
  
  CONCLUSIONS
  'Co-administration' with DHEA did not result in consistent improvements in sexual function, mood and quality of life indicators in women taking EE/DRSP. Retrospectively, the 50 mg dose of DHEA may be too low for this COC.
  
  
  CONCLUSIONS
  A well-balanced judgment of the clinical consequences of normalizing androgens during COC use may require complete normalization of free T.
authors.affiliation: Pantarhei Bioscience, Zeist, The Netherlands. Electronic address: yz@pantarheibio.com.
authors.forename: Y
authors.initials: Y
authors.lastname: Zimmerman
authors.affiliation: Department of Gynecology-Obstetrics, University Hospital CHR Citadelle, Site Sainte Rosalie, Liège, Belgium.
authors.forename: J-M
authors.initials: JM
authors.lastname: Foidart
authors.affiliation: Department of Gynecology-Obstetrics, University Hospital CHR Citadelle, Site Sainte Rosalie, Liège, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Pintiaux
authors.affiliation: Department of Laboratory Medicine, University Hospital CHR Citadelle, Liège, Belgium.
authors.forename: J-M
authors.initials: JM
authors.lastname: Minon
authors.affiliation: Department of Reproductive Medicine & Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: B C J M
authors.initials: BC
authors.lastname: Fauser
authors.affiliation: Department of Psychology, School of Natural Sciences, University of Stirling, Stirling, United Kingdom.
authors.forename: K
authors.initials: K
authors.lastname: Cobey
authors.affiliation: Pantarhei Bioscience, Zeist, The Netherlands.
authors.forename: H J T
authors.initials: HJ
authors.lastname: Coelingh Bennink
mesh_terms: D000152:Acne Vulgaris / Q000139:chemically induced / Q000517:prevention & control; D000293:Adolescent; D000328:Adult; D000726:Androgen Antagonists / Q000009:adverse effects; D000736:Androstenes / Q000009:adverse effects*; D001530:Belgium; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D003687:Dehydroepiandrosterone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000139:chemically induced / Q000503:physiopathology / Q000517:prevention & control*; D011788:Quality of Life; D012735:Sexual Dysfunction, Physiological / Q000209:etiology / Q000517:prevention & control; D020018:Sexual Dysfunctions, Psychological / Q000209:etiology / Q000517:prevention & control; D012995:Solubility; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000819:agonists / Q000037:antagonists & inhibitors / Q000097:blood* / Q000737:chemistry; D055815:Young Adult
chemical_list: D000726:Androgen Antagonists; D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C534342:drospirenone and ethinyl estradiol combination; D013739:Testosterone; D004997:Ethinyl Estradiol; D003687:Dehydroepiandrosterone
keywords: Androgens; DHEA; Mood; Sexual function; Testosterone