title: Combined esterified estrogens and methyltestosterone versus esterified estrogens alone in the treatment of loss of sexual interest in surgically menopausal women.
abstract: OBJECTIVE
  To compare the effect of esterified estrogens and methyltestosterone versus esterified estrogens alone on diminished sexual interest in surgically menopausal women.
  
  
  METHODS
  This randomized, double-blind study compared the effect of combined esterified estrogens (1.25 mg) and methyltestosterone (2.5 mg) (EE/MT) versus esterified estrogens (1.25 mg) alone (EE) for 8 weeks. Several different sexual function questionnaires were used to measure response to therapy. Changes from baseline in sexual interest/function and hormone levels were evaluated after 4 and 8 weeks of treatment.
  
  
  RESULTS
  A total of 102 women were randomized into the study; 52 (age range, 32-61 years) to EE/MT and 50 (age range, 33-62 years) to EE. After 8 weeks, significant differences between treatments were not seen in the Changes in Sexual Functioning Questionnaire (CSFQ-F-C) sexual desire/interest subscale score, the primary efficacy variable. In contrast statistically significant between-treatment differences were found for several secondary efficacy variables including Menopausal Sexual Interest Questionnaire (MSIQ) sexual interest/desire score, CSFQ-F-C arousal/erection subscale score and Women's Health Questionnaire sexual functioning subscale score. The mean serum concentration of bioavailable and free testosterone significantly increased, approximately doubling between baseline and the end of the study in patients receiving EE/MT, with a significant (P < 0.001) between-treatment difference. The mean serum concentration of sex hormone-binding globulin significantly decreased to less than one third of the pretreatment levels in patients receiving EE/MT (P < 0.001). Both treatments were well tolerated.
  
  
  CONCLUSIONS
  The mixed results seen with the different sexual function questionnaires may be due to the CSFQ-F-C's lack of specificity for this population. Increased levels of bioavailable and free testosterone paralleled the improved MSIQ item scores. Both the EE and EE/MT treatments were well tolerated.
authors.affiliation: Department of Psychiatry, University of Oklahoma Health Sciences Center, Tulsa, OK 74135, USA. faye-biggs@ouhsc.edu
authors.forename: Julia K
authors.initials: JK
authors.lastname: Warnock
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Swanson
authors.forename: Raymond W
authors.initials: RW
authors.lastname: Borel
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Zipfel
authors.forename: John J
authors.initials: JJ
authors.lastname: Brennan
mesh_terms: D000328:Adult; D045930:Anabolic Agents / Q000627:therapeutic use*; D001682:Biological Availability; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000627:therapeutic use*; D042724:Estrogens, Esterified (USP) / Q000627:therapeutic use*; D004970:Estrone / Q000097:blood; D005260:Female; D006801:Humans; D007989:Libido; D008593:Menopause; D008777:Methyltestosterone / Q000627:therapeutic use*; D008875:Middle Aged; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000097:blood / Q000493:pharmacokinetics
chemical_list: D045930:Anabolic Agents; D004967:Estrogens; D042724:Estrogens, Esterified (USP); D012738:Sex Hormone-Binding Globulin; D004970:Estrone; D013739:Testosterone; D008777:Methyltestosterone