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J Paseka

Publications and source records attributed to J Paseka.

9 recordsLinked to original sources
PubMed2000

[Prediction of the effect of a triphasic contraceptive agent with norgestimate on acne].

OBJECTIVE: Prediction of complexion changes in users of triphasic oral contraceptive containing norgestimate. DESIGN: Analysis of data from a prospective multicentre open study. SETTING: Department of Obstetrics and Gynaecology, Charles University, Prague. METHODS: Acne severity was evaluated in users of a triphasic norgestimate-containing contraceptive within a six month period. Based on subjective evaluation of acne, three subgroups of patients were selected: A) users where acne improved or disappeared; B) users in whom acne deteriorated, C) users who newly developed acne. Differences between group A and the other groups were established in the proportion or distribution of parameters related to the etiology of acne: age, weight, weight changes during the study, presence of hirsutism, presence of a regular menstrual cycle prior to the start of hormonal contraception use, and smoking. RESULTS: The effect of the pill use on acne was assessed in a total of 3,990 women. Out of 1,201 women with acne before the start of the study, improvement or disappearance of acne during the study was reported by 940 users (subgroup A) (78.27%). In 221 women (18.40%), the extent of acne remained unaltered whereas it increased (subgroup B) in only 30 women (2.50%). Acne newly developed during the study in 49 women (subgroup C), i.e., in 1.2% of the whole group. Users showing deterioration of acne (subgroup B) were found to have hirsutism less frequently. The subgroup even showed a decrease in mean weight during the study. Users with newly developed acne were--compared with subgroup A--significantly older, had a lower weight at the start of the study, and showed a higher frequency of regular menstrual cycles prior to starting hormonal contraception. The differences in the incidence of clinical parameters in the subgroups reached only borderline statistical significance and, hence, are not relevant. CONCLUSION: An extensive multicentric study confirmed the beneficial effect of a triphasic norgestimate-containing contraceptive on complexion. The presence of clinical parameters related to the etiology of acne does not allow to predict the individual response of the skin to hormonal therapy.

Acne Vulgaris↗
PubMed2000

[The factor V Leiden mutation in users of hormonal contraceptives].

OBJECTIVE: To assess the frequency of factor V Leiden in oral contraceptive users and to define possible anamnestic data that could predict the presence of factor V Leiden. METHODS: Between 1997 and 1998, 583 users of oral estrogen-progestin contraceptives with no history of thrombotic disease were examined. Factor V Leiden was assessed by PCR after isolating DNA from a peripheral venous blood sample. Among other factors, such things as a family history of thromboembolic disease, myocardial infarction and/or stroke in a first-degree relative were monitored. In 448 users cardiovascular complications were evaluated during six months of oral contraceptive use. The data were analyzed using a MS Excel program. P-values were assessed by pair-tests and chi-square tests. SETTING: 1st Department of Obstetrics and Gynecology of Medical Faculty, Masaryk University, Brno. RESULTS: Factor V Leiden frequency was 6.5% in the study group. There were no differences between carriers and others in age, body weight, body mass index and blood pressure. Carriers had significantly more frequently positive family histories of thromboembolic disease or myocardial infarction or stroke. There were no cardiovascular complications observed in a group of 448 users. The positive family histories of any of the above-mentioned conditions have high specificity (97-99%) and a negative predictive value (0.94) with a low sensitivity (2.6-15.8%) in predicting factor V Leiden presence. CONCLUSION: We found a relatively high incidence of Factor V Leiden among oral contraceptive users without a history of thrombotic disease. Through a positive family history of thromboembolic disease or myocardial infarction or stroke, we can predict a Factor V Leiden presence with high specificity but low sensitivity.

Adolescent↗
PubMed2000

[Liver function tests during administration of triphasic contraceptives containing Norgestimate].

OBJECTIVE: To evaluate serum levels of liver enzymes and bilirubin before and after six cycles of use of a triphasic oral contraceptive containing 35 micrograms of ethinylestradiol and 180/215/250 micrograms of norgestimate (Pramino, Janssen-Cilag). DESIGN: A prospective, open-label, non-comparative, multicentric phase IV study. SETTING: Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University, Prague. METHOD: Before the start and after six cycles of Pramino use, the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GMT), and bilirubin were determined in women. As the analyses were performed in different laboratories, the evaluation involved: 1. Subgroups of women examined in laboratories with the same reference range; 2. A group of women examined in laboratories with the upper reference range within the mean +/- SD interval; 3. Percentage variations of the measured values from a concrete upper reference limit. RESULTS: When evaluating subgroups of women from laboratories with the same standards, significant decreases in AST and bilirubin were seen in some subgroups, a rise in GMT in one subgroup; the other changes were non-significant. When assessing the entire group and percentage variations from standard, a mild rise in GMT was again seen; however, the values remain deep within the normal range. Values above the upper reference limit at the start of the study either do not change significantly throughout the study, or they normalize spontaneously. CONCLUSION: No clinically significant changes in liver function tests occurred in users of a triphasic oral contraceptive containing norgestimate along with 35 micrograms EE over a period of six cycles of use. The results, as judged by their dynamics, suggest liver function tests are not a useful tool for routine monitoring a healthy combined oral contraceptive user.

Contraceptives, Oral, Combined↗
PubMed1999

[Clinical study of a triphasic contraceptive preparation (Norgestimate 180/215/250 micrograms + ethinylestradiol 35 micrograms) in a population of Czech women].

OBJECTIVE: To assess the efficacy, acceptability and safety of triphasic oral contraceptive pill containing norgestimate 180/215/250 micrograms and ethinylestradiol 35 micrograms. DESIGN AND SETTING: Prospective, open-label, non-comparative, multicenter study in 409 centers in the Czech Republic. METHODS: Body weight, blood pressure, bleeding pattern, headaches, nausea, breast tenderness, acne, pregnancies and side effects were monitored before the start of the treatment, after three and six cycles of oral contraceptive use. Liver function tests were carried out before and after the treatment. RESULTS: Evaluating 26,432 cycles in 4,720 women the theoretical Pearl index was 0.15. There were no significant changes in body weight (61.45 kg before vs 61.58 kg after the treatment). There were clinically significant changes neither in the blood pressure nor in the liver function tests. Evaluating the bleeding pattern there were similar incidences of irregular bleeding/spotting before the treatment and up to the third treatment cycle (16.15%, resp. 17.86%); then the incidence dropped down (8.41% after the third cycle). Amenorhea was very rare (0.41% resp. 0.35% up to, resp. after the third cycle). Decreasing incidences compared to pretreatment state were observed for headache, breast tenderness and acne. The effect on acne was remarkable (28.3% of women complaining of acne before the treatment vs 6.51% after the six treatment cycles). There were no serious adverse events observed during this study. CONCLUSION: Triphasic oral contraceptive pill containing norgestimate and ethinylestradiol proved in a large multicenter study high both efficacy and acceptability.

Adolescent↗