title: A pilot study of an investigational testosterone transdermal patch system in young women with spontaneous premature ovarian failure.
abstract: BACKGROUND
  Evidence suggests that young women with spontaneous premature ovarian failure (sPOF) have significantly lower androgen levels than age-matched regularly menstruating women.
  
  
  OBJECTIVE
  The objective of the study was to evaluate an investigational testosterone transdermal patch (TTP) designed to deliver the normal ovarian production rate of testosterone.
  
  
  METHODS
  This was an open-label study (2-month baseline period followed by 2-month treatment period).
  
  
  METHODS
  Nine women with sPOF and a history of regular bleeding patterns on standard estrogen/progestogen cyclic treatment participated in the study. One subject with abnormal baseline levels was excluded.
  
  
  METHODS
  Four consecutive 28-d cycles of transdermal estradiol (E2; 0.1 mg/d) and sequential oral medroxyprogesterone acetate (MPA; 10 mg/d for the last 12 d of each cycle). During cycles 3 and 4, an investigational TTP (nominal delivery 150 microg/d) was applied twice weekly to the abdomen.
  
  
  METHODS
  Steady-state pharmacokinetic profiles of free and total testosterone and scheduled vaginal bleeding patterns were studied.
  
  
  RESULTS
  The mean (95% confidence interval) of the time-average free testosterone levels during TTP treatment was 7.5 (4.9-9.9) pg/ml; 26.0 (17.2-34.6) pmol/liter (with E2), and 6.9 (4.9-8.8) pg/ml; 23.9 (17.2-30.5) pmol/liter (with E2 and MPA). The confidence intervals of the means include the upper limit of normal for premenopausal women, i.e. 6.8 pg/ml (23.5 pmol/liter), although the mean values are slightly above this.
  
  
  CONCLUSIONS
  The addition of TTP to cyclic E2/MPA therapy in women with sPOF produced mean free testosterone levels that approximate the upper limit of normal. A 3-yr study to assess safety and effectiveness in this population is in progress.
authors.affiliation: Developmental Endocrinology Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892, USA.
authors.forename: Sophia N
authors.initials: SN
authors.lastname: Kalantaridou
authors.forename: Karim A
authors.initials: KA
authors.lastname: Calis
authors.forename: Norman A
authors.initials: NA
authors.lastname: Mazer
authors.forename: Heidy
authors.initials: H
authors.lastname: Godoy
authors.forename: Lawrence M
authors.initials: LM
authors.lastname: Nelson
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000728:Androgens / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006728:Hormones / Q000097:blood; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D010865:Pilot Projects; D016649:Primary Ovarian Insufficiency / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000728:Androgens; D006728:Hormones; D013739:Testosterone