A pilot study of an investigational testosterone transdermal patch system in young women with spontaneous premature ovarian failure.
J Clin Endocrinol Metab
; 90(12): 6549-52, 2005 Dec.
Article
em En
| MEDLINE
| ID: mdl-16174721
ABSTRACT
CONTEXT 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.DESIGN:
This was an open-label study (2-month baseline period followed by 2-month treatment period). PATIENTS 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. INTERVENTION 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. MAIN OUTCOMEMEASURES:
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.
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Base de dados:
MEDLINE
Assunto principal:
Testosterona
/
Insuficiência Ovariana Primária
/
Androgênios
Limite:
Adult
/
Female
/
Humans
Idioma:
En
Ano de publicação:
2005
Tipo de documento:
Article