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At least 19 recordsLinked to original sources
PubMed1990

The effects of different formulations of oral contraceptive agents on lipid and carbohydrate metabolism.

BACKGROUND: Oral contraceptives can induce changes in lipid and carbohydrate metabolism similar to those associated with an increased risk of coronary heart disease, including increased serum triglyceride, low-density lipoprotein (LDL) cholesterol, and insulin levels and decreased high-density lipoprotein (HDL) cholesterol levels. In this study, we examined whether modification of the type or dose of progestin in oral-contraceptive preparations diminishes these changes. METHODS: We measured plasma lipoprotein levels and performed oral glucose-tolerance tests in a cross section of 1060 women who took one of nine types of oral contraceptives for at least three months and 418 women who took none. Seven of the contraceptive formulations contained various doses and types of progestin: levonorgestrel in low (150 micrograms), high (250 micrograms), and triphasic (50 to 125 micrograms) doses; norethindrone in low (500 micrograms), high (1000 micrograms), and triphasic (500 to 1000 micrograms) doses; and a new progestin, desogestrel, in one dose (150 micrograms). All seven contained 30 to 40 micrograms of ethinyl estradiol. Two additional formulations contained progestin alone. RESULTS: As compared with controls, women taking combination drugs did not have increased serum total cholesterol levels but did have increases of 13 to 75 percent in fasting triglyceride levels. Levels of LDL cholesterol were reduced by 14 percent in women taking the combination containing desogestrel and by 12 percent in those taking low-dose norethindrone. Levels of HDL cholesterol were lowered by 5 percent and 16 percent by the combinations containing low-dose and high-dose levonorgestrel, respectively; these decreases were due to reductions of 29 percent and 43 percent, respectively, in the levels of HDL subclass 2. The combination pill containing high-dose norethindrone did not affect HDL cholesterol levels, whereas that containing low-dose norethindrone increased HDL cholesterol levels by 10 percent. The desogestrel combination increased HDL cholesterol levels by 12 percent. Levels of apolipoproteins A-I, A-II, and B were generally increased by combination drugs. Depending on the dose and type of progestin, combination drugs were associated with plasma glucose levels on the glucose-tolerance test that were 43 to 61 percent higher than in controls, insulin responses 12 to 40 percent higher, and C-peptide responses 18 to 45 percent higher. Progestin-only formulations had only minor metabolic effects. CONCLUSIONS: The appropriate dose and type of progestin may reduce the adverse effects of oral contraceptives on many metabolic markers of risk for coronary heart disease. Progestin-only formulations or combinations containing desogestrel or low-dose norethindrone were associated wtih the most favorable profiles.

Adolescent↗
PubMed1990

Effect of low-dose oral contraceptives on carbohydrate and lipid metabolism in women with recent gestational diabetes: results of a controlled, randomized, prospective study.

Women with recent gestational diabetes mellitus were randomly assigned to one of two low-dose oral contraceptives to evaluate the effect of low-dose oral contraceptives on carbohydrate and lipid metabolism. A cohort of similar women requesting a non-oral-contraceptive method served as controls. The two oral contraceptives studied were ethinyl estradiol (0.035 mg)-norethindrone (0.40 mg) and ethinyl estradiol (0.030 to 0.040 mg)-levonorgestrel (0.050 to 0.125 mg). A 75 gm, 2-hour oral glucose tolerance test and a fasting lipid profile (total cholesterol, triglyceride, high- and low-density lipoprotein cholesterols) were performed at entry, after 3 months, and after 6 to 13 months of treatment. The prevalence of diabetes at 6 to 13 months (27/156 patients) was not significantly different between groups (non-oral-contraceptive group, 17%; ethinyl estradiol-norethindrone, 15%; ethinyl estradiol-levonorgestrel, 20%). When examined by prior gestational diabetes mellitus class, diabetes mellitus was present in 7% of prior class A1 and 29% of women with prior class A2 disease (p less than 0.001). Mean cholesterol and low-density lipoprotein cholesterol levels were significantly improved in all three groups at 3 months and at 6 to 13 months, whereas triglycerides remained unchanged. There were no differences in cholesterol, low-density lipoprotein cholesterol, or triglycerides levels between the groups. After 6 to 13 months, there was a significant increase in high-density lipoprotein cholesterol in the ethinyl estradiol-norethindrone group compared with the ethinyl estradiol-levonorgestrel and non-oral-contraceptive groups.

Adult↗
PubMed1990

Oral contraceptives, lipoproteins, and atherosclerosis.

A nonhuman primate model was developed to study the effects of oral contraceptives on lipoproteins and atherosclerosis. Cynomolgus macaques were selected because of their susceptibility to diet-induced atherosclerosis and because their reproductive physiology, menstrual cycle, and circulating sex hormone patterns are similar to those of human females. The first study compared a vaginal ring containing levonorgestrel and estradiol with an oral contraceptive containing norgestrel and ethinyl estradiol. A second study compared two oral combinations: norgestrel-ethinyl estradiol and ethynodiol diacetate-ethinyl estradiol. As predicted, use of all the contraceptives led to lowering of high-density lipoprotein cholesterol levels. However, contrary to what might be expected, use of the ethinyl estradiol-containing oral contraceptives did not lead to an increase in the prevalence or extent of atherosclerosis. We concluded that ethinyl estradiol neutralized the atherogenic influence of the progestin component of oral contraceptives.

Animals↗
PubMed1985

Serum lipid and lipoprotein changes induced by new oral contraceptives containing ethinylestradiol plus levonorgestrel or desogestrel.

Changes in serum lipid and lipoprotein levels were evaluated in a randomized prospective study conducted in matched healthy young women before and after 6 months' use of three oral contraceptives (OCs): Trigynon (preparation A, n = 13), a triphasic OC containing low doses of ethinylestradiol (EE) and levonorgestrel (LNG); Marvelon (preparation B, n = 14), a monophasic OC containing low doses of EE + Desogestrel (DOG, a new progestogen derived from LNG); and Ovidol (preparation C, n = 11), a sequential OC containing higher doses (50 micrograms) of EE + DOG. After 6 months of use, total triglyceride levels were non-significantly increased by preparations A (+ 29% from basal values) and B (+21%), and very significantly increased by preparation C (+90%). Total cholesterol and phospholipids were unchanged by preparations A and B, whereas phospholipids were significantly increased by preparation C. However, HDL-cholesterol, LDL-cholesterol and their epidemiologically important ratios (HDL-chol:total-chol; LDL-chol:HDL-chol) were kept unchanged by all preparations tested. Apolipoprotein A-1 (Apo A-1) was slightly but significantly increased by all three preparations whereas apolipoprotein B (Apo B) was significantly decreased by preparation B. All ratios Apo A-1:Apo B were accordingly ("favorably") increased, especially during treatment with preparation B. In conclusion, the triphasic OC containing low doses of LNG does not induce obvious, clinically significant, alterations of lipid metabolism, and it is also the case for the low-dose monophasic combination of EE + DOG. The higher-dose sequential preparation of EE + DOG behaves as a more estrogenic compound, increasing total triglyceride concentrations above the normal range.

Adult↗
PubMed1988

Metabolic changes in women using a long-acting monthly oral contraceptive and return of ovulation on discontinuation.

Metabolic changes were investigated in two groups of women using oral contraceptives for 5 to 16 years. Blood samples were taken during the last cycle of oral contraceptive use and three months post-treatment. One group had used a monthly oral contraceptive (MOC, 3mg quinestrol and 10mg 16-methylene chlormadinone acetate) and the second group a daily oral contraceptive (DOC, 35 micrograms ethynylestradiol and 0.625 mg norethisterone). During treatment there were increases in serum total cholesterol and triglycerides but not HDL-C, in plasma total cortisol but not in renin activity, angiotensin II or urinary free cortisol excretion, in hemoglobin and some coagulation factors but not Factor X or antithrombin III, platelet function or fibrinolysis. The area under the blood glucose concentration-time curve, but not that for serum insulin, was slightly increased and there was no change in fasting blood sugar concentrations. All metabolic parameters, except plasma cortisol, which had shown an increase on treatment, had decreased to control levels within 3 months. Ovulation returned promptly in all women, the mean time being 70 days for Group MOC and 44 days for Group DOC. Thus, in spite of the long duration of use of the oral contraceptives, metabolic changes were minor.

Adult↗
PubMed1990

A comparative study of the effects of a monophasic and a triphasic oral contraceptive containing ethinyl estradiol and levonorgestrel on lipid and lipoprotein metabolism.

A comparative study of the effects of a monophasic and a triphasic oral contraceptive containing ethinylestradiol (EE) and levonorgestrel (LNG) on lipid and lipoprotein metabolism was conducted on 45 Singapore women under the WHO Special Programme of Research in Human Reproduction. The women were randomly allocated to one of the two pill groups--a triphasic preparation containing low doses of LNG and EE in various proportions and a monophasic preparation of 150 micrograms LNG and 30 micrograms EE, and an additional 18 women, choosing to use IUDs, were recruited as controls. Blood samples were taken at admission, 3 and 12 months thereafter. For both pill groups, total cholesterol decreased with duration of use, while HDL cholesterol decreased slightly at 3 months and thereafter increased. LDL cholesterol decreased slightly at 3 months, returning to baseline at 12 months for the monophasic group, while remaining unchanged at 12 months for the triphasic group. The monophasic preparation appeared to lower total, LDL and HDL cholesterols to a greater extent at 3 months than the triphasic preparation. Compared with IUD users, for the monophasic group, both total and HDL cholesterols were significantly lower at 3 months and HDL and LDL cholesterols were lower at 12 months. In addition, ratios of HDL cholesterol/LDL cholesterol and HDL cholesterol/total cholesterol were significantly lower at 12 months. Changes in triglycerides were minimal for both pill groups. However, at 3 months, triglycerides for the triphasic group were significantly higher than the IUD users, but this observation was not of any clinical importance since comparison of changes with their respective pretreatment values were not statistically significant. These results indicate that these changes are related to the dosage and estrogen-progestogen ratio of the preparation. Furthermore, the monophasic preparation may have a disadvantage over the triphasic preparation since it appears to cause more disturbance in lipid metabolism. However, it is noted that these changes in lipids and lipoproteins were minimal and did not appear to be of any clinical significance.

Adolescent↗
PubMed1990

Comparison of the lipoprotein and hemostatic changes after a triphasic and a monophasic low dose oral contraceptive in premenopausal middle-aged women.

Metabolic and hemostatic effects of 2 low dose oral contraceptives (OCs), a triphasic (ethinylestradiol + (-)-norgestrel) and a monophasic (ethinylestradiol + desogestrel) preparation, were compared in a cross-over trial in fertile women over 35 years of age. Both combinations moderately affected plasma lipids, with 17-24% increases of total triglyceridemia. Triglycerides accumulate in low density lipoproteins, thus suggesting the possible formation of an atherogenic lipoprotein particle. Only the monophasic preparation increased high density lipoprotein (HDL)-cholesterol levels significantly, with a rise in HDL3 mass and cholesterol. OC treatment led to slight changes in HDL2 and HDL3 structure, with a rise of the cholesteryl ester and triglyceride contents, indicative of a stimulated cholesterol esterification and reverse transport. Changes in the hemostatic indexes (fibrinogen, antithrombin III and protein C) were negligible. The new low dose OCs, even when prescribed to relatively older women, affect to a relatively small extent lipid/lipoprotein metabolism, with the exception of changes in the low density lipoprotein composition.

Adult↗
PubMed1987

Effects of three low-dose oral contraceptive formulations on lipid metabolism.

Three oral contraceptive preparations were studied in 60 healthy women. This randomized, comparative, baseline controlled study was designed to investigate the effects of the preparations on plasma lipids and lipoproteins. The following formulations were studied: a monophasic preparation containing ethinylestradiol and desogestrel (M-DSG) and two triphasic formulations containing ethinylestradiol and gestodene or levonorgestrel respectively (T-GSD and T-LNG). These preparations were studied for six treatment cycles. Total cholesterol and apoprotein B did not change in any group. Low density lipoprotein (LDL) cholesterol was significantly decreased in the groups of women treated with M-DSG and T-GSD respectively. No changes were observed in the T-LNG group. With M-DSG, significant increases were observed in high-density lipoprotein (HDL) cholesterol and HDL3 cholesterol, whilst HDL2 cholesterol did not change. With both T-GSD and T-LNG, no changes were observed in HDL cholesterol, whilst a significant increase in HDL3 cholesterol together with a trend to decrease in HDL2 cholesterol were observed. Apolipoprotein AI increased with the following ranking M-DSG greater than T-GSD greater than T-LNG. The LDL/HDL cholesterol ratio significantly decreased with both M-DSG and T-GSD. In the T-LNG group there was no change in this ratio. Triglycerides increased to the same extent in all treatment groups. As far as concerns the risk of arterial diseases, these three oral contraceptive formulations mostly induced negligible and/or partly favorable changes in plasma lipids and lipoproteins; however, the lipoprotein pattern during M-DSG treatment resulted better than during T-GSD, and the latter turned out to be better than during T-LNG.

Adolescent↗
PubMedDate not supplied

Clinical evidence of the minimal androgenic activity of norgestimate.

The goal in improving the progestational component of oral contraceptives (OCs) is to enhance the selectivity of the progestin by achieving a high degree of contraceptive efficacy while decreasing undesirable side effects associated with existing progestational agents. The androgenic activity of current progestins results in changes in lipid metabolism, particularly decreased levels of high-density lipoprotein cholesterol (HDL), which have been associated with an increased risk of coronary heart disease (CHD). A progestin with high antiovulatory activity and minimal androgenicity would offer a clear therapeutic advantage in oral contraception. Norgestimate (NGM) is a new progestin with a unique profile of biological activity that has demonstrated a high level of selectivity in preclinical assays. The present studies were conducted to confirm clinically the low androgenic activity of NGM. Norgestimate (0.25 mg) in combination with 0.035 mg ethinyl estradiol (NGM 0.25/35) was compared with 0.30 mg norgestrel combined with 0.030 mg ethinyl estradiol (Lo/Ovral) in two multicenter clinical studies. In the first study (1,261 women), HDL levels were significantly increased from baseline levels in NGM 0.25/35 subjects but were significantly decreased in Lo/Ovral subjects. Increases in low-density lipoprotein cholesterol (LDL) levels were moderate in the NGM 0.25/35 group and pronounced in the Lo/Ovral group. A favorable lipid profile in NGM 0.25/35 subjects was also reflected in the LDL/HDL ratios, which were significantly lower in the NGM 0.25/35 subjects than in the Lo/Ovral subjects. Sex hormone binding globulin (SHBG) binds androgens, preventing clinical expression of androgenic activity. As a result, elevations in SHBG levels reduce bioactive (unbound) androgen levels and decrease the potential for androgenic side effects.(ABSTRACT TRUNCATED AT 250 WORDS)

Acne Vulgaris↗
PubMed1989

Study design for the Triphasic Randomized Clinical Trial.

The Triphasic Randomized Clinical Trial was a multicenter, open-label, controlled, 6-month study to determine the influence of three currently marketed triphasic oral contraceptives on lipid and carbohydrate metabolism, cyclic bleeding profiles, and other adverse drug experiences. The study protocol mandated four clinic visits: an initial visit during which study eligibility was determined, a second visit during which baselines were obtained for lipid and carbohydrate parameters, and visits at 3 and 6 months while taking the study drug. The study enrolled healthy women between the ages of 18 and 35 years who were within 20% of their ideal body weight and who had a history of normal and regular menstrual cycles. Patients were randomly assigned to one of three treatment groups: 51 patients to Tri-Levlen, 50 patients to Ortho-Novum 7/7/7, and 56 patients to Tri-Norinyl. The control group consisted of 49 patients using nonhormonal forms of birth control. Eighty-eight percent (181/206) of the patients completed all four visits and were considered evaluable for subsequent analyses.

Adolescent↗
PubMed1988

New natural oestradiol/cyproterone acetate oral contraceptive for pre-menopausal women.

Fifty (50) healthy ovulating women aged between 35 and 47 yr (mean age 39) were randomly allocated to one of two groups treated with biphasic formulations of either oestradiol valerate/cyproterone acetate (Group A) or oestradiol valerate/norethisterone (Group B). A double-blind design was used during the first 6 mth of treatment. In Group A, 21 out of 26 women (81%), and in Group B, 16 out of 24 (67%) completed the first year of treatment. No pregnancies occurred. The mid-cycle serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) peaks were suppressed, but there were no differences between the pretreatment serum oestradiol values and those observed during the treatment cycles. The serum progesterone values indicated that only one ovulatory cycle occurred during the first year in Group A, while there were 11 in Group B. Ultrasonic studies revealed follicular growth during treatment in both groups, most follicles becoming atretic or persistent without ovulation. No significant changes were observed in 11 coagulation factors studied in 16 women in Group A. Serum total cholesterol decreased by about 10% in both groups. In Group A bleeding became scantier and dysmenorrhoea disappeared. The incidence of spotting varied between 30% and 40%, but it is important to note that the total number of bleeding days per cycle fell. The oestradiol valerate/cyproterone acetate combination was thus found to inhibit ovulation, provide tolerable cycle control and to be free from adverse metabolic side effects.

Adult↗
PubMed1986

Effects on the lipoprotein metabolism of an antiandrogen-estrogen oral contraceptive drug.

The effects on the lipoprotein metabolism of six cycles of treatment with 2 mg of the anti-androgenic progestogen Cyproterone acetate + 50 micrograms of ethinyl estradiol were prospectively studied in 22 healthy premenopausal women. The plasma level of cholesterol (C) was unchanged, while the levels of HDL-C and its subfractions HDL2-C and HDL3-C were significantly elevated after only one cycle. The LDL-C decreased after one month but then returned to pretreatment levels. VLDL-C was unchanged. The phospholipid concentrations within the various lipoprotein fractions generally resembled those of the corresponding cholesterol fraction. The levels of fibrinogen in plasma and of triglycerides in plasma and in the lipoprotein fractions were elevated. It is concluded that the drug had a predominant and rather pronounced estrogenic profile.

Acne Vulgaris↗
PubMed1991

The effect of low-dose oral contraceptives on lipids and lipoproteins in two at-risk populations: young female smokers and older premenopausal women.

Young women who smoke and women over age 35 are considered to be at high risk for cardiovascular complications associated with oral contraceptive use. This study evaluated the effects of low-dose oral contraceptives on lipid and lipoprotein concentrations in 45 high-risk patients before, during, and after 6 months of treatment. Neither group showed a significant change from baseline in cholesterol, HDL cholesterol, LDL cholesterol or cholesterol ratios. Triglycerides increased and HDL2a levels decreased significantly in both groups but returned to baseline after treatment was discontinued, with the largest changes in both triglycerides and HDL2a levels occurring at 1 month. The change in triglyceride and HDL2a blood levels were within the laboratories' reference range. The lipid profile of these patients, therefore, was not worsened significantly through 6 months of oral contraceptive use. The young women who smoked did have consistently lowered levels of HDL cholesterol and its HDL2a subfraction when compared to their elder non-smoking cohort.

Adult↗
PubMed1989

Contraceptive efficacy of norethindrone encapsulated in injectable biodegradable poly-dl-lactide-co-glycolide microspheres: phase II clinical study.

Contraceptive efficacy of injectable norethindrone (NET) microspheres of 90 day duration was evaluated for 6 months: nine women received two injections of 65 mg each and eight received two injections of 100 mg each with 90 days between each injection. Average serum NET levels were 5 to 9 ng/mL on the day after injection and subsequently remained at 1 to 3 ng/mL. With 65 and 100 mg doses, respectively, 36% and 25% of cycles had normal bleeding patterns, 36% and 48% were amenorrheic, and the remaining 28% and 27% had prolonged bleeding. Also, 56% and 40% of cycles showed increased spotting for the 65 mg and 100 mg dose, respectively. There was no incidence of pregnancy or serious side effects. The mean serum NET concentration returned to RIA nonspecific basal levels 100 days after the second injection. Women returned to ovulatory cycles between days 100 to 115 after the second injection.

Adult↗
PubMedDate not supplied

Effects of desogestrel and gestodene in low-dose oral contraceptive combinations on lipid and lipoprotein status. A randomized prospective study.

This study was designated to assess the effects of two low-dose oral contraceptives (OC) on serum lipids and lipoproteins and to compare, at same oestrogen dose (30 micrograms), the effects of desogestrel (DG) with those of a new progestin, gestodene (GD). Fifty-four young women, matched for Quetelet's Index, age, diet, alcohol consumption, smoking and exercise habits, were randomly assigned to one of two regimens. Serum high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total triglycerides (T) and cholesterol (C), apolipoprotein A-1 (Apo A) and apolipoprotein B (Apo B) were measured prior to the OC commencement and after 6-cycle treatment. Sex hormone binding globulin (SHRG) and ceruloplasmin (CP) were determined as well. LDL-C, Apo A, C, T, increased significantly from baseline values, being still the increase within the reference range. Apo B changed proportional to the LDL-C increase. A rise in HDL-C occurred but it was statistically significant in the EE-DG group only. This result would suggest that the EE-DG combination is more estrogen-dominant that the EE-GD combination. However, this hypothesis was not consistent with the increase to the similar extent for SHBG and CP, which reflect the estrogenicity/gestagenicity of the two OCs. The disproportion of change between HDL-C and Apo A in only EE-GD group might reflect some compositional change in HDL particle. There were no significant differences between the two formulations for the parameters investigated.

Adult↗
PubMed1990

Effects of oral contraceptives on carbohydrate and lipid metabolisms in a healthy population: the Telecom study.

In a cross-sectional study that aimed to identify risk factors for diabetes, 1290 consecutive, healthy, nonpregnant women of child-bearing age were examined in a center for preventive medicine. An in-depth interview about menses, use of oral contraceptives, and menopause was performed. Plasma glucose at fasting and 2 hours after a 75 gm glucose load, glycated hemoglobin A1c, fasting plasma insulin, total plasma cholesterol, and triglycerides were measured. Compared with nonusers taking no progestogens, oral contraceptive users (n = 431; 33.4%) were younger (p less than 0.001) and leaner (p less than 0.001). After adjustment for age and body mass index, oral contraceptive users had higher 2-hour plasma glucose (p less than 0.001), higher fasting plasma insulin (p less than 0.01), and higher triglycerides levels (p less than 0.01). Fasting plasma glucose, glycated hemoglobin A1c, and total cholesterol did not significantly differ between the two groups. In relation to dosage and types of steroid components, few differences have been found between high-dose and low-dose oral contraceptives or according to the estrogen-progestogen balance of the preparations. Use of oral contraceptives appears to induce an increase of insulin-resistance markers, which have recently been cited as risk factors for ischemic vascular diseases. These markers should be carefully monitored in oral contraceptive users.

Adult↗
PubMed1987

A new low-dose estrogen oral contraceptive combination: effect on endocrine parameters and lipid status.

In this study the variations of endocrine and metabolic parameters of 39 women treated with a new oral contraceptive combination containing 20 mcg of ethinylestradiol and 150 mcg of desogestrel were examined. Gonadotropins and androgen presented a significant decrease, showing the efficiency of suppression of the pituitary-ovarian activity and of the contraceptive effect. The significant increase of SHBG and the corresponding reduction of free testosterone reflect the estrogenic environment of this pill and the low androgenicity of desogestrel. During the observation period, plasma levels of total cholesterol, trglycerides, LDL-C and HDL2-C were not altered, whereas total phospholipids, HDL-C and HDL3-C increased significantly. Besides a general positive effect on the main lipid parameters involved in atherogenic process, this pill also presented an optimal subjective tolerability.

Adult↗