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Revista Brasileira de Ginecologia e Obstetrícia. 1998;20(6):309-313
DOI 10.1590/S0100-72031998000600003
Objective: to evaluate variations in body weight, arterial blood pressure, fasting glucose, HbA1C, insulin, total cholesterol, HDL-C, LDL-C, triglycerides, Sgot, SGPT, GGT and bilirubin in women bearing a single subdermal Silastic implant containing 55 mg (+ 10%) of nomegestrol acetate during two years. Methods: eighteen healthy volunteers of reproductive age who desired to use anticonceptive drugs and who did not present contraindications to hormonal contraception participated in the study. All women were investigated before starting treatment and were followed-up for two years. At the end of the first year the capsules were inserted. Results: body weight increased from 54.9 + 1.5 kg at admission to 55.3 + 2.0 kg at 12 months of use (p<0.05) and from 56.0 + 2.7 kg at 24 months of use. There was a slight increase in arterial blood pressure, both systolic and diastolic, at month 12 (p<0.01). At month 24, the arterial blood pressure was not significantly different from the values at admission. All values were within the normal range. Insulin, HbA1C, LDL-C and GGT remained unchanged during the use of the implant. A significant decrease in total cholesterol (p<0.05) was observed in the third month and of HDL-C (p<0.01) in the sixth month. All lipoprotein alterations were inconsistent and values were within the normal range. Significant increases in fast glucose (p<0.05 and p<0.01) were observed in the third and sixth months, respectively. Significant SGOT decreases (p<0.05, p<0.01 and p<0.05) were observed in months 6, 18 and 24, respectively, and of SGPT (p<0.05) in month 18. Significant bilirubin increase (p<0.05) was observed only in the third month of implant use. All these variations remained within the normal range. Conclusions: these results show that, within the normal range, fasting glucose variations do not correlate with alterations in insulin levels. The slight serum lipoprotein, SGTO, SGPT and insulin alterations were transient. No clinical effects could be observed regarding lipoproteins, carbohydrate metabolism, insulin levels and liver function among the users during the two years.
Summary
Revista Brasileira de Ginecologia e Obstetrícia. 1998;20(6):309-313
DOI 10.1590/S0100-72031998000600003
Objective: to evaluate variations in body weight, arterial blood pressure, fasting glucose, HbA1C, insulin, total cholesterol, HDL-C, LDL-C, triglycerides, Sgot, SGPT, GGT and bilirubin in women bearing a single subdermal Silastic implant containing 55 mg (+ 10%) of nomegestrol acetate during two years. Methods: eighteen healthy volunteers of reproductive age who desired to use anticonceptive drugs and who did not present contraindications to hormonal contraception participated in the study. All women were investigated before starting treatment and were followed-up for two years. At the end of the first year the capsules were inserted. Results: body weight increased from 54.9 + 1.5 kg at admission to 55.3 + 2.0 kg at 12 months of use (p<0.05) and from 56.0 + 2.7 kg at 24 months of use. There was a slight increase in arterial blood pressure, both systolic and diastolic, at month 12 (p<0.01). At month 24, the arterial blood pressure was not significantly different from the values at admission. All values were within the normal range. Insulin, HbA1C, LDL-C and GGT remained unchanged during the use of the implant. A significant decrease in total cholesterol (p<0.05) was observed in the third month and of HDL-C (p<0.01) in the sixth month. All lipoprotein alterations were inconsistent and values were within the normal range. Significant increases in fast glucose (p<0.05 and p<0.01) were observed in the third and sixth months, respectively. Significant SGOT decreases (p<0.05, p<0.01 and p<0.05) were observed in months 6, 18 and 24, respectively, and of SGPT (p<0.05) in month 18. Significant bilirubin increase (p<0.05) was observed only in the third month of implant use. All these variations remained within the normal range. Conclusions: these results show that, within the normal range, fasting glucose variations do not correlate with alterations in insulin levels. The slight serum lipoprotein, SGTO, SGPT and insulin alterations were transient. No clinical effects could be observed regarding lipoproteins, carbohydrate metabolism, insulin levels and liver function among the users during the two years.
Summary
Revista Brasileira de Ginecologia e Obstetrícia. 2004;26(6):449-454
DOI 10.1590/S0100-72032004000600005
OBJECTIVE: to study the effect of a single contraceptive implant of nomegestrol acetate (Uniplant) on the ovarian function, cervical mucus production and sperm penetration, when inserted in women in the preovulatory phase. METHODS: twenty women with regular menstrual cycles were included in an open comparative study. All participants were investigated during one menstrual cycle before (control) and one menstrual cycle after implant insertion. Measurements of estradiol, LH, and progesterone, as well as transvaginal sonography, cervical mucus examination and sperm penetration test, were carried out. Statistical analysis was performed with the paired t-test and the non-parametric test of Wilcoxon. RESULTS: all control cycles were ovulatory and presented normal parameters. Preovulatory estradiol and LH peak decreased significantly from 603.2 ± 78.0 pmo/l and 22.5 ± 6.5 IU/l at pre-insertion to 380.7 ± 51.9 pmol/l and 4.9 ± 1.3 IU/l 48 hours after implant insertion (p < 0.05 and p < 0.01, respectively). Progesterone levels did not vary significantly (control cycle = 49.8 ± 3.3 nmol/l and treated cycle = 43.2 ± 5.2 nmol/l). Cervical mucus and sperm penetration tests were profoundly affected in 10.5% of the users 20 h after implant insertion, in 68.5% after 24 h and in 100% after 48 h. Follicular rupture occurred in the majority of the cycles 48 h after implant insertion. CONCLUSIONS: the use of a single implant of nomegestrol acetate affected estradiol and LH preovulatory peaks and disrupted the process of cervical mucus production and sperm penetration, but it was unable to prevent ovulation when inserted at the preovulatory phase, which reinforces the need to insert the implant during the first five days of the menstrual cycle.
Summary
Revista Brasileira de Ginecologia e Obstetrícia. 2004;26(6):449-454
DOI 10.1590/S0100-72032004000600005
OBJECTIVE: to study the effect of a single contraceptive implant of nomegestrol acetate (Uniplant) on the ovarian function, cervical mucus production and sperm penetration, when inserted in women in the preovulatory phase. METHODS: twenty women with regular menstrual cycles were included in an open comparative study. All participants were investigated during one menstrual cycle before (control) and one menstrual cycle after implant insertion. Measurements of estradiol, LH, and progesterone, as well as transvaginal sonography, cervical mucus examination and sperm penetration test, were carried out. Statistical analysis was performed with the paired t-test and the non-parametric test of Wilcoxon. RESULTS: all control cycles were ovulatory and presented normal parameters. Preovulatory estradiol and LH peak decreased significantly from 603.2 ± 78.0 pmo/l and 22.5 ± 6.5 IU/l at pre-insertion to 380.7 ± 51.9 pmol/l and 4.9 ± 1.3 IU/l 48 hours after implant insertion (p < 0.05 and p < 0.01, respectively). Progesterone levels did not vary significantly (control cycle = 49.8 ± 3.3 nmol/l and treated cycle = 43.2 ± 5.2 nmol/l). Cervical mucus and sperm penetration tests were profoundly affected in 10.5% of the users 20 h after implant insertion, in 68.5% after 24 h and in 100% after 48 h. Follicular rupture occurred in the majority of the cycles 48 h after implant insertion. CONCLUSIONS: the use of a single implant of nomegestrol acetate affected estradiol and LH preovulatory peaks and disrupted the process of cervical mucus production and sperm penetration, but it was unable to prevent ovulation when inserted at the preovulatory phase, which reinforces the need to insert the implant during the first five days of the menstrual cycle.