Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17ß-oestradiol in comparison to one containing levonorgestrel and ethinylestradiol on markers of endocrine function.

OBJECTIVES: To compare the effects of two monophasic combined oral contraceptives, containing either nomegestrol acetate/17ß-oestradiol (NOMAC/E2) or levonorgestrel/ ethinylestradiol (LNG/EE) on endocrine function, androgens, and sex hormone-binding globulin (SHBG). METHODS: Randomised, open-label, multi-centre trial involving 121 healthy women, aged 18-50 years old. Participants received NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=60) or LNG/EE (150 µg/30 µg) in a 21/7-day regimen (n=61) for six cycles. The primary outcome was the change from baseline to cycle 6 in markers of adrenal and thyroid function, androgens, and SHBG. RESULTS: Total cortisol, corticosteroid-binding globulin (CBG), and thyroxine-binding globulin (TBG) increased from baseline in both groups, with significantly greater increases in the LNG/EE group. No relevant changes from baseline or differences between the groups were observed for thyroid-stimulating hormone (TSH) and free thyroxine (T4). Androgens and androgen precursors decreased from baseline in both groups, with significantly greater decreases in the LNG/EE group (except for free testosterone). A greater increase in SHBG was observed with NOMAC/E2 than with LNG/EE. CONCLUSIONS: NOMAC/E2 has significantly less influence on markers of adrenal and thyroid function and androgens than LNG/EE. The clinical relevance of these findings requires further study.

Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17ß-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism.

OBJECTIVES: To compare the effects of a combined oral contraceptive (COC) containing nomegestrol acetate and 17ß-oestradiol (NOMAC/E2) on haemostasis, lipids, carbohydrate metabolism, C-reactive protein (CRP) and sex hormone-binding globulin (SHBG) with those of a COC containing levonorgestrel and ethinylestradiol (LNG/EE). METHODS: In a randomised, open-label study, 121 healthy women, 18-50 years of age, were randomly assigned to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=60) or LNG/EE (150 µg/30 µg) in a 21/7-day regimen (n=61) for six cycles. The primary outcome was the change from baseline to cycle 6 for all indices. RESULTS: All parameters were similar at baseline between the two groups. Over six cycles, NOMAC/E2 had less effect on most haemostatic indices than LNG/EE. Lipids were essentially unchanged with NOMAC/E2, whereas with LNG/EE high-density lipoprotein cholesterol decreased and low-density lipoprotein cholesterol and triglycerides slightly increased. NOMAC/E2 induced negligible changes in glucose and insulin parameters, in contrast to LNG/EE. A much smaller increase in CRP was observed with NOMAC/E2 than with LNG/EE. NOMAC/E2 was associated with a greater increase in SHBG. CONCLUSIONS: The monophasic COC NOMAC/E2 had less influence on haemostasis, lipids and carbohydrate metabolism than the COC LNG/EE.

Are recurrent pregnancies a risk in Type 1 diabetes?

OBJECTIVE: To assess the significance of recurrent pregnancies for the progression of Type 1 diabetes as well as the glycemic level and the occurrence of pre-eclampsia in consecutive pregnancies of the same Type 1 diabetic women. METHODS: A retrospective population-based birth cohort from the years 1986-95, comprising data of all (n = 210) Type 1 diabetic mothers and their 296 births in a geographically defined catchment area. Of the 125 primiparous women, 46 had their first two pregnancies during the study period. The courses of their first and second pregnancies were compared to determine the level of glycemic control and the occurrence and recurrence of complications, such as pre-eclampsia and aggravated retinopathy. The characteristics of the 53 women who remained primiparous were evaluated. RESULTS: Retinopathy was aggravated more often during the first pregnancy (95% CI 0.1-1.0), but its incidence did not increase further by the beginning of the second pregnancy. Pre-eclampsia complicated 16.9% of all pregnancies: it was more common during the first than second pregnancy (95% CI 0.3-1.5) and its occurrence increased with the increasing severity of diabetes. Glycemic control was better in the second pregnancy, including both the periconceptional period (95% CI 0.7-2.8) and the later stages of pregnancy (95% CI 1.1-4.7). The women in the White classes F/R most often remained primiparous. CONCLUSIONS: Retinopathy was aggravated most often during the first pregnancy, but its infrequent occurrence in the second pregnancy reflects the reversible nature of these changes. The significance of the past pregnancy experience contributed to the increased tendency for optimal glycemic control in the second pregnancy.