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PubMed1990

[Pharmacokinetics of ethinyl estradiol following the administration of combination contraceptive preparations].

A radioimmunoassay for ethinylestradiol (EE2) which was developed in the pharmacological department of VEB Jenapharm has been modified and fully validated. It was the purpose of the present study to extend the still limited data concerning EE2-serum levels after a single and repeated ingestion of combination pills with different doses of EE2. 10 volunteers aged 17-25 years with normal body weight and length received a single tablet of either Gravistat (0.05 mg ethinylestradiol + 0.125 mg levonorgestrel) or Minisiston (0.03 mg ethinylestradiol + 0.125 mg levonorgestrel). 11 other women were involved into the study after ingestion of the 21st tablet of a contraceptive cycle. Peak serum levels which were significantly higher in the Gravistat- than in the Minisiston-group were observed 90 to 120 minutes after the oral administration. Detectable EE2 levels were determined in all volunteers after 24 hours. Pharmacokinetic data showed pronounced interindividual variations. Whereas the mean 24 hours levels of EE2 increased progressively during the treatment cycles, kinetic values obtained at the end of the cycle exhibited a significantly higher level than those after ingestion of a single dose. Area under curve (AUC) was calculated by the trapezoidal rule with the aid of a compartment free model.

Adolescent↗
PubMed1986

Cyproterone acetate versus levonorgestrel combined with ethinyl estradiol in the treatment of acne. Results of a multicenter study.

In spite of an abundant literature on antiandrogen treatment with cyproterone acetate (CA) there have been no objectively measured results to prove statistically the possible superiority of CA over combined oral contraceptive pills in the treatment of acne vulgaris. A multicenter study was therefore done, in which two preparations containing CA in combination with ethinylestradiol (EE) were compared with a marketed combined oral contraceptive pill. The preparations studied were: CA 2 mg + EE 50 micrograms (Diane), CA 2 mg + EE 35 micrograms (Diane mite), Levonorgestrel 150 micrograms + EE 30 micrograms (Neovletta). A woman was eligible for the study if she was found by a dermatologist to have at least eight acne lesions (sum of papules, pustules, cysts and nodules) on her face, was otherwise healthy and without medication. After a primary assessment of the number of acne lesions by the dermatologist the woman was referred to a gynecologist and given one of the three test preparations double-blind and at random. The treatment was to continue for 6 months. 133 women were recruited at eight different centers. The groups thus constituted were of similar size and comparable with regard to age, degree of acne, and menstrual and contraceptive histories. As the number of acne lesions varied considerably between patients all data were converted into percentage change during treatment before they were processed in a computer. After only 4 months of treatment the patients on Diane and Diane mite had a significantly greater reduction in the number of acne lesions compared with those on Neovletta.(ABSTRACT TRUNCATED AT 250 WORDS)

Acne Vulgaris↗
PubMedDate not supplied

Conversion of tibolone to 7alpha-methyl-ethinyl estradiol using gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry: interpretation and clinical implications.

OBJECTIVE: Tibolone, a hormone therapy drug, is used to treat climacteric symptoms. This drug is rapidly metabolized into three major metabolites (3alpha-hydroxytibolone, 3beta-hydroxytibolone, and Delta4-tibolone). One clinical study provided evidence of conversion of tibolone to another estrogenic metabolite, 7alpha-methyl-ethinyl estradiol (MEE). However, no evidence of MEE formation was found in another study using the human aromatase enzyme. Because MEE was analyzed by gas chromatography-mass spectrometry (GC-MS), which requires derivatization, together with the fact that derivatization of some steroids may lead to aromatization, it is feasible that the MEE detected resulted from an artifact generated during the derivatization process. Hence, our objective was to assess whether tibolone is converted to MEE. DESIGN: We assayed MEE formation in a nonbiological system using GC-MS after derivatization and by analyzing MEE formation using liquid chromatography-mass spectrometry (LC-MS) in nonderivatized samples. RESULTS: MEE formation was evident in tibolone samples derivatized with either pentafluoropropionic anhydride or trimethylsilyl and analyzed by GC-MS. The amount of MEE formed increased with increasing amounts of tibolone (0.5, 1, 2.5, and 5 microg) derivatized; however, relative to tibolone, the percentage of MEE formed remained constant and ranged between 0.22% and 0.29% of tibolone. In contrast to GC-MS, no MEE formation was seen when tibolone was analyzed by liquid chromatography-mass spectrometry without derivatization. CONCLUSIONS: Our findings prove that conversion of tibolone to MEE is an artifact that is generated in a GC-MS system and is largely due to the intense heating step involved in GC-MS. Caution should be exercised to extrapolate clinical implications from existing data on MEE formation using a GC-MS system.

Chromatography, Liquid↗
PubMed1994

Pharmacokinetics of a triphasic oral contraceptive containing desogestrel and ethinyl estradiol.

OBJECTIVE: To demonstrate that pharmacokinetic measurements were made at steady state. Subsequently, dose proportionality for desogestrel and ethinyl E2 kinetics were demonstrated. DESIGN: Open-label, noncomparative study. SETTING: Healthy volunteers in an academic research environment. PARTICIPANTS: Twenty white women who were 19 to 32 years old were solicited via an advertisement. Nineteen of the 20 women completed the study. INTERVENTIONS: Study medication consisted of three cycles of a triphasic oral contraceptive containing desogestrel and ethinyl E2. Blood samples were taken at baseline and during cycle 3 between -48 and 24 hours on days 1, 7, 14, and 21, with additional sampling times on day 21 at 48, 60, and 72 hours. MAIN OUTCOME MEASURES: Serum concentrations of 3-keto-desogestrel and ethinyl E2. RESULTS: Evaluation of the trough serum levels indicated that a steady state of 3-keto-desogestrel had been reached. Statistical analysis on the Cmax, area under the curve (AUC), and Css,min indicated dose proportionality for the administered desogestrel. Ethinyl E2 serum levels obtained at the same time points also reflected steady state levels and showed minimal variability. The statistical analysis on Cmax, AUC, Css,min, and Tmax indicated that the pharmacokinetics of ethinyl E2 on days 7, 14, and 21 were not statistically significantly different, indicating dose equivalency. CONCLUSIONS: Steady state of 3-keto-desogestrel is reached after each of the three phases and the pharmacokinetics are dose proportional. After reaching steady state, the pharmacokinetics of ethinyl E2 remain constant over time.

Adult↗