A pilot study of an investigational testosterone transdermal patch system in young women with spontaneous premature ovarian failure
| dc.contributor.author | Kalantaridou, S. N. | en |
| dc.contributor.author | Calis, K. A. | en |
| dc.contributor.author | Mazer, N. A. | en |
| dc.contributor.author | Godoy, H. | en |
| dc.contributor.author | Nelson, L. M. | en |
| dc.date.accessioned | 2015-11-24T19:39:55Z | |
| dc.date.available | 2015-11-24T19:39:55Z | |
| dc.identifier.issn | 0021-972X | - |
| dc.identifier.uri | https://olympias.lib.uoi.gr/jspui/handle/123456789/24279 | |
| dc.rights | Default Licence | - |
| dc.subject | Administration, Cutaneous | en |
| dc.subject | Adult | en |
| dc.subject | Androgens/*administration & dosage/adverse effects/therapeutic use | en |
| dc.subject | Female | en |
| dc.subject | Hormones/blood | en |
| dc.subject | Humans | en |
| dc.subject | Menstrual Cycle/drug effects | en |
| dc.subject | Pilot Projects | en |
| dc.subject | Primary Ovarian Insufficiency/blood/*drug therapy/physiopathology | en |
| dc.subject | Testosterone/*administration & dosage/adverse effects/therapeutic use | en |
| dc.title | A pilot study of an investigational testosterone transdermal patch system in young women with spontaneous premature ovarian failure | en |
| heal.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 OUTCOME MEASURES: 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. | en |
| heal.access | campus | - |
| heal.fullTextAvailability | TRUE | - |
| heal.identifier.primary | 10.1210/jc.2005-0692 | - |
| heal.identifier.secondary | http://www.ncbi.nlm.nih.gov/pubmed/16174721 | - |
| heal.identifier.secondary | http://jcem.endojournals.org/content/90/12/6549.full.pdf | - |
| heal.journalName | J Clin Endocrinol Metab | en |
| heal.journalType | peer-reviewed | - |
| heal.language | en | - |
| heal.publicationDate | 2005 | - |
| heal.recordProvider | Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής | el |
| heal.type | journalArticle | - |
| heal.type.el | Άρθρο Περιοδικού | el |
| heal.type.en | Journal article | en |
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