title: A placebo-controlled study of effects of oral progesterone on performance and mood.
abstract: 1. Oral micronized progesterone (P) is proposed for the treatment of certain endocrine gynaecological disorders. To examine the effects of P on performance and mood, a randomized, placebo-controlled study of 24 healthy females ages 18-24 years on low-dose oral contraceptives was conducted. 2. Subjects were admitted to the Clinical Research Center on four occasions and received single doses of oral P (300, 600, 1200 mg) or placebo. Blood sampling, psychometric tests and mood scales were administered at baseline and at hourly intervals for 6 h. 3. P doses produced significant dose-related but highly variable increases in plasma P concentrations. Fatigue increased with P doses, although few subjects were objectively drowsy. Very high peak plasma P concentrations, achieved by some subjects at the 1200 mg dose, were associated with decreased information processing and verbal memory function as well as fatigue. 4. We conclude that oral P can safely be prescribed at higher than previously-reported doses, based on evidence of transient behavioural effects only at the highest doses in some subjects who achieved high plasma P concentrations.
authors.affiliation: Department of Obstetrics/Gynecology, University of Pennsylvania, Philadelphia 19104.
authors.forename: E W
authors.initials: EW
authors.lastname: Freeman
authors.forename: L
authors.initials: L
authors.lastname: Weinstock
authors.forename: K
authors.initials: K
authors.lastname: Rickels
authors.forename: S J
authors.initials: SJ
authors.lastname: Sondheimer
authors.forename: C
authors.initials: C
authors.lastname: Coutifaris
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000339:Affect / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D010919:Placebos; D011374:Progesterone / Q000008:administration & dosage / Q000494:pharmacology*; D011597:Psychomotor Performance / Q000187:drug effects*
chemical_list: D010919:Placebos; D011374:Progesterone