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Title: Comparative bioavailability of orally and vaginally administered progesterone.
Austin Authors: Norman, Trevor R ;Morse, C A;Dennerstein, L
Affiliation: Department of Psychiatry, University of Melbourne, Austin Hospital, Heidelberg, Victoria, Australia
Issue Date: 1-Dec-1991
Publication information: Fertility and Sterility; 56(6): 1034-9
Abstract: To study the pharmacokinetics of progesterone (P) in healthy premenopausal female volunteers to compare the bioavailability of orally or vaginally administered hormone.Subjects were randomly allocated to receive either oral P or a vaginal pessary then crossed over to the alternate preparation 1 month later.The study was conducted in outpatient setting.All subjects were healthy, normal female volunteers who underwent a physical and gynecological examination before the study. None were using oral contraceptives. Ten subjects (mean age 32.6 +/- 7.3 years) entered the study and all completed it.Progesterone was administered as 200 mg of micronized hormone or as a pessary containing 400 mg.Plasma levels of P were measured by radioimmunoassay to test the apriori hypothesis of similar bioavailability.Peak plasma P concentrations attained within 4 hours after oral administration ranged from 8.5 to 70.6 ng/mL, whereas after vaginal administration the peak levels were attained within 8 hours and ranged from 4.4 to 181.1 ng/mL. Considerable interindividual variation was noted. Area under the plasma concentration-time curve for the two formulations was not significantly different (F = 1.09; P greater than 0.1; ANOVA).The two formulations had similar bioavailability.
Gov't Doc #: 1743318
Journal: Fertility and sterility
Type: Journal Article
Subjects: Australia
Data Analysis
Developed Countries
Endocrine System
Examinations And Diagnoses
Laboratory Examinations And Diagnoses
Progestational Hormones
Progesterone--administraction and dosage
Progesterone--side effects
Research Methodology
Administration, Oral
Analysis of Variance
Biological Availability
Osmolar Concentration
Progesterone.administration & dosage.blood.pharmacokinetics
Random Allocation
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