A quantitative biometrological assessment of acne and hormonal evaluation in young women using a triphasic low-dose oral contraceptive containing gestodene.

OBJECTIVE: To investigate the effect of a triphasic low-dose oral contraceptive pill containing gestodene on acne severity and hormone levels in young women over 13 menstrual cycles. METHODS: A total of 33 subjects aged 16-25 years with moderate facial acne were enrolled in the study. The primary efficacy end-points used in the clinical assessment of acne were the overall severity and number of lesions, sebum secretion and superficial follicular biopsy. Both physicians and patients evaluated acne status. Blood levels of sex hormone binding globulin (SHBG), estradiol, progesterone and androgens were monitored. RESULTS: By cycle 13, the total lesion count had been reduced by 80%. Physicians and patients assessed acne status in 90% and 95% of cases, respectively, as better or much better (p < 0.001). At the end of the study, SHBG levels had increased by 229% and total and free testosterone levels had decreased by 41% and 70%, respectively. CONCLUSION: An oral contraceptive containing triphasic gestodene has a beneficial effect on the severity ofacne, decreases major circulating androgen levels and is well tolerated.

Plasma concentration of endothelin-1 in women with cocaine-associated pregnancy complications.

OBJECTIVE: The purpose of this study was to determine if the plasma concentration of endothelin-1 is elevated in pregnant women abusing cocaine and to determine how these levels differ from those in patients with preeclampsia and in women with uncomplicated pregnancies. STUDY DESIGN: Plasma endothelin-1 levels were measured in 30 women with acute cocaine intoxication, 32 women with preeclampsia, 14 pregnant women with chronic hypertension, 26 women with uncomplicated pregnancies, and 16 nonpregnant individuals. Serial samples after delivery were obtained in 12 women with preeclampsia, 10 with cocaine abuse, 4 with chronic hypertension, and 7 with uncomplicated pregnancies. RESULTS: The mean endothelin-1 concentration in those with cocaine abuse was 18.2 +/- 8.1 pg/ml (95% confidence interval 15.2 to 21.2). This was similar to that in women with preeclampsia (21.1 +/- 5.9 pg/ml, 95% confidence interval 19 to 23.3) (p = 0.2) but significantly different from that in women with chronic hypertension (11.5 +/- 3.6 pg/ml, 95% confidence interval 9.4 to 13.6) (p < 0.001) and women with uncomplicated pregnancies (6.7 +/- 3.9 pg/ml, 95% confidence interval 5.1 to 8.2) (p < 0.001). CONCLUSIONS: Endothelin-1 levels in women abusing cocaine are comparable to those in women with preeclampsia and are significantly higher than those in gravid women with chronic hypertension and women with uncomplicated pregnancies. Elevated levels of endothelin-1 may contribute to some of the pregnancy-related complications in women abusing cocaine.

A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives. Gestodene Study Group.

This was an open-label multicenter study to compare the cycle control and effect on well-being of two oral contraceptives containing gestodene and one containing desogestrel. A total of 2419 healthy women < or = 41 years of age were randomized to receive oral contraceptives containing monophasic gestodene (Minulet; n = 806, mean age 24.5 years), triphasic gestodene (Tri-Minulet; n = 808, mean age 24.6 years) or monophasic desogestrel (Mercilon; n = 805, mean age 24.6 years). Subjects were to participate in the study for up to 13 treatment cycles. A modified Moos Menstrual Distress Questionnaire was used to evaluate menstrual symptoms and to assess overall well-being. A total of 698 women were withdrawn from the study, 154 due to adverse events. Cycle control with gestodene was superior to that with desogestrel at almost all time points, particularly for breakthrough bleeding and/or spotting, which occurred significantly less frequently with gestodene than with desogestrel at cycles 1-7 and 9-11 (p < 0.05). Generally, the proportion of subjects with breakthrough bleeding and/or spotting was almost twice as great with desogestrel as with gestodene. The duration of bleeding was not consistently different between the gestodene and desogestrel groups; however, the intensity of bleeding was greater with gestodene at all time points (p < 0.05). The latent period before withdrawal bleeding was significantly longer for monophasic gestodene at cycles 1-5 and 8-10 (p < 0.05). Treatment significantly improved overall well-being at cycles 6 and 9 with triphasic gestodene and at cycle 13 with desogestrel; however, no statistically significant differences among treatment groups in overall well-being scores or individual factors of well-being could be identified. All three treatments were well tolerated. The most common drug-related adverse events were headache (14.2%), breast pain (6.2%), nausea (4.1%), metrorrhagia (3.9%) and abdominal pain (3.5%). The incidence of adverse events in all treatment groups was similar, with the exception of metrorrhagia, which occurred in more patients in the desogestrel group than in the gestodene treatment groups (p < 0.05).