Clinical investigation of the biological effects of a new combination low-dose oral contraceptive ('Ovostat E').
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Adult↗
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Results for “Contraceptives, Oral, Sequential”
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Sequential danazol/leuprolide acetate therapy for ovarian suppression in an in vitro fertilization patient unresponsive to leuprolide acetate.
We report a case of pituitary-ovarian suppression obtained with sequential danazol/leuprolide acetate administration in a patient undergoing in vitro fertilization and unresponsive to leuprolide acetate alone and sequential oral contraceptive-leuprolide acetate therapy. Leuprolide acetate (1 mg daily subcutaneously) was administered after 5 weeks of danazol treatment (800 mg daily) while the latter was maintained for 1 additional week. Ovarian activity was assessed by transvaginal ultrasonography and serum estradiol determination. After 5 weeks of danazol therapy, ovarian arrest was obtained despite the fact that gonadotropin serum levels did not change relative to basal values. Leuprolide acetate injection for 14 days was associated with a decrease in serum concentrations of follicle-stimulating hormone and luteinizing hormone and a further decrease of the estradiol level. We conclude that sequential danazol/leuprolide acetate therapy is a useful alternative for obtaining ovarian arrest in patients unresponsive to leuprolide acetate alone.
Adult↗
Fertility following discontinuation of different methods of fertility control.
The possibility of permanent sterility following use of modern contraceptive agents is a concept which causes great concern amongst members of the lay public. However, a thorough review of the literature gives a great deal of reassurance on this topic. The combined oral contraceptive pill causes slight delay, and the injectable contraceptives a moderate delay in the return of fertility following discontinuation, but there is no evidence of a greater likelihood of permanent infertility than in the normal population. The progestogen-only minipill should be risk-free, but final data are lacking. Epidemiological studies do not indicate an increased risk of infertility following IUD use, but it seems likely that there must be a very small number of IUD users who develop permanent infective damage to the Fallopian tubes. Barrier methods and periodic abstinence probably do not have any significant effect on subsequent fertility. Barrier methods could be protective. Therapeutic abortion may have a small deleterious effect on long-term reproductive success, but the data are inconclusive. Detailed information on fertility following use of other methods is not available.
Abortion, Induced↗
Divergent effects of weight reduction and oral anticonception treatment on adrenergic lipolysis regulation in obese women with the polycystic ovary syndrome.
The influence of weight reduction and female sex hormones on the regulation of lipolysis was investigated in isolated abdominal sc adipocytes from 20 obese hyperandrogenic women with polycystic ovary syndrome (PCOS). Nine PCOS women were reinvestigated after 8-12 weeks of weight reduction therapy (WR) with a very low calorie diet, inducing a mean loss of 8 +/- 3 kg, and 8 PCOS women were reinvestigated after 12 weeks of treatment with combined oral contraceptives (OC), containing ethinyl estradiol and norethisterone; the remaining 3 subjects were drop-outs. Both WR and OC normalized hyperandrogenicity. WR caused a 50% reduction of basal lipolysis rate and a 5- to 7-fold increased noradrenaline and terbutaline sensitivity (P < 0.02); the latter could be ascribed to a 2-fold increased beta2-adrenoceptor density (P < 0.02) as determined with radioligand binding. There was no change with regard to dobutamine (beta1-adrenoceptor sensitivity) or clonidine, (alpha2-adrenoceptor sensitivity) or to beta1-adrenoceptor density. OC treatment did not influence the basal lipolysis rate or beta2- or alpha2-adrenoceptor sensitivity, but lowered the beta1-adrenoceptor sensitivity 7-fold (P < 0.03) without a reduction in beta1-adrenoceptor density. The OC treatment effect was not observed when forskolin and dibutyryl cAMP, acting on adenylate cyclase or protein kinase A, respectively, were used, suggesting a partial uncoupling of beta1-adrenoceptors. WR therapy, but not OC therapy, caused, in addition to changes in lipolysis function, improved in vivo insulin sensitivity and lower plasma noradrenaline levels. These findings suggest that factors other than hyperandrogenicity modulate lipolysis regulation in obese subjects with PCOS. Disturbances in sympathetic pathways could be of pathogenic importance.
Adipocytes↗
A clinical comparison of two triphasic oral contraceptives with levonorgestrel or norethindrone: a prospective, randomized, single-blind study.
Menstrual bleeding patterns were investigated in young women taking either a levonorgestrel triphasic, Triquilar, or a norethindrone triphasic, Ortho 7/7/7, two commonly prescribed low-dose oral contraceptives. The levonorgestrel triphasic contains ethinyl estradiol (EE) 30 micrograms + levonorgestrel (LNG) 50 micrograms for the first six days, EE 40 micrograms + LNG 75 micrograms for the following five days, and EE 30 micrograms + LNG 125 micrograms for the last ten days. The norethindrone triphasic contains EE 35 micrograms + norethindrone (NET) 0.5 mg for the first seven days, EE 35 micrograms + NET 0.75 mg for the following seven days and EE 35 micrograms + NET 1.0 mg for the last seven days. Three hundred women from 16 to 25 years of age were randomized to the levonorgestrel triphasic (n = 150) or the norethindrone triphasic (n = 150) groups. Assessments were made from daily diary cards and from bimonthly investigator interviews over 6 pill cycles. The results showed a higher incidence of intermenstrual bleeding (breakthrough bleeding and/or spotting) in the norethindrone triphasic group (NET group) than in the levonorgestrel triphasic group (LNG group): 44.9% of patients (66/147) randomized to the LNG group reported intermenstrual bleeding one or more times during the study compared with 61.9% (91/147) randomized to the NET group (p = 0.0036). Furthermore, in subjects who did not miss any pills, the proportion of patients with intermenstrual bleeding in each cycle was significantly greater (p < 0.02, cycles 1-4, 6; p > 0.05, cycle 5) and was experienced for more days per cycle (p < 0.05, cycle 1) and for more cycles per patient (p < 0.05, 5 cycles) in the NET group compared with the LNG group. Intermenstrual bleeding was also less frequently observed in the LNG group than in the NET group in patients who missed pills (p < 0.05, cycles 3, 5 and 6). In addition, early withdrawal bleeding occurred more often in the NET group than in the LNG group (p < 0.05, cycles 1, 3 and 4). The incidence of amenorrhea was similar in both groups. These results demonstrate a significantly lower incidence of intermenstrual bleeding and therefore better cycle control with the levonorgestrel triphasic Triquilar, compared with the norethindrone triphasic Ortho 7/7/7.
Adolescent↗
[Colposcopic findings during hormonal contraception].
The best way to recognize individual differences and alterations of colposcopic findings is by photography. The results of an improved colpophotographic technique is the reproduction of the complete portio. In consequence we can observe the changes of the cervix epithelium which often are extensive and hypertrophic and which in some cases are to be found during the time of hormonal contraception. The different effects of the combination-pill and of the sequential pill are described, the question of individual disposition concerning these alterations is discussed.
Adult↗
Attenuation of mild hyperandrogenic activity in postpubertal acne by a triphasic oral contraceptive containing low doses of ethynyl estradiol and d,l-norgestrel.
The effect of a low dose triphasic oral contraceptive (OC) was evaluated during a 6-month treatment period in 41 patients (mean age, 25.4 +/- 0.7 yr) who had grade I-IV postpubertal acne and normal menses. The OC contained three dose levels of ethynyl estradiol and dl-norgestrel. Acne lesions were assessed, and serum androgen levels were measured during a control cycle and between days 17-21 of treatment cycles 1, 2, 3, and 6. Four patients dropped out after 3 months of treatment. Acne was significantly improved after the first OC cycle. After six cycles, the number of comedones had decreased by 79.6 +/- 3.2% (range, 50-100%) in 69.4% of the patients. Mean baseline levels of testosterone, 17-hydroxyprogesterone, and dehydroepiandrosterone sulfate were in the upper third of the normal range, with elevated individual values in 18.9%, 36.5%, and 26.8% of the women, respectively. Mean baseline levels of androstenedione, free testosterone (T), and 3 alpha-androstanediol glucuronide (3 alpha-diol-G) were above the normal range, with elevated individual values in 51.2%, 75.0%, and 85.4% of the patients, respectively. Sex hormone-binding globulin (SHBG) levels were below the normal range in 26.8% of the cases. At the end of the first OC cycle, there was a significant (P less than 0.01) decrease in all androgen precursors and a 2-fold increase in SHBG. Androstenedione and free T decreased into the normal range during OC intake. Serum 3 alpha-diol-G levels remained elevated, but had decreased by 34.5% at cycle 6 (P less than 0.05). These results show that the triphasic OC has significantly improved acne in postpubertal women for whom acne was the main manifestation of mild hyperandrogenic activity. The improvement in acne corresponded to a decrease in adrenal/ovarian androgens and free T, which led to a decreased metabolism to 3 alpha-diol-G, presumably by the sebaceous glands. The increase in SHBG is considered an estrogenic effect, and the triphasic formulation containing low dose dl-norgestrel is not androgenic but, rather, an estrogen-dominant formulation; as such, this product is recommended in women requiring contraception who also have idiopathic acne.
Acne Vulgaris↗
[Modification of serum lipids and glucose tolerance by sequential Ovosiston and Minisiston].
The influence of two kinds of contraceptive pills, a sequential one and a combined one (Sequenz-Ovosiston and Minisiston), on serum lipoproteins and carbohydrate metabolism was investigated in 32 young patients who got these drugs for the first time during a period of 12 months. There were no pathological values of cholesterol, high density proteins, low density proteins, triglycerides or oral glucose tolerance test during and after the treatment. The authors summarized, that neither Sequenz-Ovosiston nor Minisiston increase the risk of atherosclerosis and of diabetes in young healthy women.
Adolescent↗
Recurrent hemolytic uremic syndrome during oral contraception.
A 23-year-old multiparous normotensive woman developed a hemolytic uremic syndrome (HUS) five months postpartum, and four months after starting estro-progestogen contraception. Eight years later a recurrence appeared, five years after a successful cadaver kidney transplantation and ten months after resumption of the estro-progestogen intake. In the interval a pure progestogen contraceptive was prescribed without problems. This observation is consistent with the hypothesis that HUS can be triggered by oral estrogen intake in predisposed individuals.
Adult↗
Evaluation of the clinical performance of three triphasic oral contraceptives: a multicenter, randomized comparative trial.
Three hundred thirteen women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding and or spotting) associated with the use of three triphasic oral contraceptives. Triphasil (n = 107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n = 97) and Tri-Norinyl (n = 109), both of which contain norethindrone and ethinyl estradiol, were administered over four cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimens. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use.
Adolescent↗
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↗
A prospective treatment study of premenstrual symptoms using a triphasic oral contraceptive.
Eighty-two women with complaints of moderate to severe premenstrual symptoms were recruited for a double-blind, controlled trial of a triphasic oral contraceptive (o.c.). Subjects made daily ratings of symptoms for at least one baseline cycle and were then randomly assigned to receive either placebo or o.c. for three months. Twenty-three women dropped out of the study (18 o.c., 5 placebo), 13 failed to show prospective confirmation of moderate to severe premenstrual symptoms, and one placebo subject had an anovulatory cycle. Forty-five women with prospectively-confirmed premenstrual changes (20 o.c., 25 placebo) completed the study. Premenstrual breast pain and bloating were significantly reduced with active treatment compared to placebo (p less than 0.03) but there were no beneficial effects of the o.c. over placebo for any of the mood symptoms. Women who received o.c.s reported decreased sexual interest after starting treatment and this effect was independent of any adverse influence on mood.
Adult↗
Evaluation of a new triphasic oral contraceptive in private practice.
We evaluated the clinical and metabolic effects of a new triphasic regimen developed in the continuing attempt to reduce the dose of estrogen and progestogen in oral contraceptives. A combination of ethinyl estradiol (EE) and levonorgestrel (LNg) was used (six tablets with 30 micrograms EE + 50 micrograms LNg, five tablets with 40 micrograms EE + 75 micrograms LNg, and 10 tablets with 30 micrograms EE + 125 micrograms LNg), also known as Triphasil (Wyeth). In a private practice, 409 subjects participated in 7,286 treatment cycles. Three pregnancies occurred, all due to subject failure. Menstrual regulation was excellent and the incidence of side effects extremely low. Withdrawals from the study for possibly drug-related medical reasons totaled 9.0% through 56 cycles of treatment. Metabolic changes also were evaluated in 14 of these women over a 6-month period. The only statistically significant increase in carbohydrate values occurred at 6 months. The mean glucose level at 30 minutes of the oral glucose tolerance test was above the baseline mean value, but serum insulin levels showed no statistically significant deviation. Lipid values presented are total lipids, total cholesterol, triglycerides, alpha-, beta-, and pre-beta-lipoproteins, and high density and low density lipoprotein cholesterol. There was no statistically significant difference between the mean values at baseline and those during treatment for any lipid variable. These results indicate that this triphasic oral contraceptive has a high degree of efficacy, a low incidence of side effects, excellent cycle control, and high subject compliance, and would seem to indicate a minimal influence on the metabolism of lipids and carbohydrates in the small number of subjects studied.
Blood Glucose↗
The effect of a biphasic desogestrel-containing oral contraceptive on carbohydrate metabolism and various hormonal parameters.
During 6 cycles of treatment of 19 women, the effect of a low-dose biphasic oral contraceptive containing 40 micrograms ethinylestradiol + 25 micrograms desogestrel (7 tablets) and 30 micrograms ethinylestradiol + 125 micrograms desogestrel (15 tablets) on various hormonal parameters and glucose metabolism was compared with the values of the pre- and post-treatment cycle. There was a profound reduction in gonadotropin secretion and ovarian steroid synthesis. The serum levels of testosterone were reduced by 35%, free testosterone by 55%, and DHEA-S by 30%. Cortisol increased by 100%, SHBG by 250%, and TBG by 60%, while FT3 and FT4 were only marginally influenced. Fasting levels of glucose and insulin did not change significantly, but the glucose load revealed a slight impairment of glucose tolerance. Three weeks after termination of pill intake, the various parameters returned to pretreatment levels, except for SHBG and TBG which were still elevated by 20 to 30%. The results demonstrate a marked preponderance of the effect of the estrogen component, a reliable inhibition of ovulation and very good cycle control during treatment with the biphasic formulation.
Adult↗
Effects of oestrogens on prolactin and thyrotrophin responses to TRH in women during the menstrual cycle and under oral contraceptive treatment.
The effects of physiological and pharmacological variations of oestrogens on prolactin and thyrotrophin (TSH) secretion have been studied during the menstrual cycle and under oral contraceptive treatment. Ten women were tested for prolactin and TSH responses to 200 mug TRH in the early follicular (days 4-6), periovulatory (days 14-15) and luteal phases (days 22-26) of the same menstrual cycle. Circulating plasma prolactin levels did not significantly vary in the three phases, but TSH basal levels were lower in the luteal than in the follicular and periovulatory periods. The prolactin response to TRH was significantly enhanced in the periovulatory phase, while the TSH response was slightly decreased. Seven women on sequential contraceptives exhibited increased basal and TRH-induced prolactin secretion during the oestrogen treatment, with an unaltered TSH secretion throughout therapy. Treatment with combined contraceptives did not alter either basal or TRH-induced prolactin secretion in eight women, but basal TSH secretion and its response to TRH were both reduced. These data show that oestrogens may produce different regulatory effects on prolactin and TSH secretion, particularly in the pituitary sensitivity to TRH stimulation. Physiological variations of oestrogen secretion such as those observed during the menstrual cycle can likewise modify prolactin levels. These results could provide some support for a regulatory role for prolactin in the menstrual cycle.
Adult↗
The pharmacology of gynaecology.
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Climacteric↗
[Peripheral blood lymphocyte subpopulations of postmenopausal women with hormone replacement therapy].
The effect of hormone replacement therapy on cellular immunity of postmenopausal women was studied by flow cytometry (FACS). Lymphocyte subsets in peripheral blood before and after hormonal replacement therapy (HRT) were measured. After 6 months of HRT with the sequential combined drug Klimonorm(R) (2 mg estradiol valerate and 0,15 mg levonorgestrel) the cytotoxic T-cells (CD8) were reduced and the CD4/CD8 ratio was increased significantly (p < 0,05).
Adult↗
Oral contraceptives and neoplasia.
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Adolescent↗