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PubMed1977

Treatment of acne vulgaris with cyproterone acetate and ethinyl estradiol.

The results obtained with low-dosage treatment with 2 mg cyproterone acetate and 0.05 mg ethinyl estradiol in 10 women with moderate to severe acne are reported. Eight of these patients showed a very good response, one a moderate response, and one showed no improvement after 3 months. In four patients the administration of antibiotics could be discontinued, and in most of the other patients the dose could be reduced. Three patients discontinued this treatment, two because of side effects and one because of lack of improvement.

Acne Vulgaris↗
PubMed1986

Bioequivalence of norethindrone and ethinyl estradiol for two different weight tablets with the same hormonal content.

Two tablets of differing weights, 100 mg (A) and 50 mg (B), of an oral contraceptive drug (OC) were compared with each other and to a solution (C) of the same components. The composition of the OC consisted of 1 mg of norethindrone (NET) and 0.035 mg of ethinyl estradiol (EE2). Both tablets were shown to differ from the solution, which was more rapidly absorbed, but were not significantly different from each other. Formulation means for NET and EE2, for each of the two products, were similar. Application of an interval test for the ratio of computed parameters demonstrated equivalence of the two formulations with respect to 0-24 hr area under the curve (AUC24) and total area under the curve (AUC+o+) for both NET and EE2 and with respect to concentration maximum (Cmax) for EE2. The data support the hypothesis for bioequivalence of the two formulations with respect to total absorption.

Absorption↗
PubMed1986

Effects of norgestimate (0.250 mg) in combination with ethinyl estradiol (0.035 mg) on cervical mucus.

The antifertility effect of norgestimate (Ng), 0.250 mg, in combination with ethinyl estradiol (EE), 0.035 mg, on cervical mucus was investigated. The study was conducted over two consecutive cycles: a control cycle followed by a study cycle during which medication was given. Basal body temperature, cervical mucus and karyopyknotic index of vaginal cells were evaluated during both cycles. Disappearance of cyclicity of these parameters in the study cycle as well as monophasic basal body temperature were suggestive of inhibition of ovulation caused by the combination pill. Deterioration of sperm penetration may be reflective of anovulation and a direct antifertility effect of Ng on cervical mucus.

Adolescent↗
PubMed1986

Effects of ethinyl estradiol on intestinal membrane structure and function in the rabbit.

Structural and functional properties of the small intestinal microvillus membrane were evaluated in the rabbit after administration of ethinyl estradiol, a synthetic estrogen with a demonstrated propensity to alter hepatic membrane lipid fluidity, and promote cholestasis. In the jejunum, no estrogen-induced changes in microvillus membrane total lipid, cholesterol or phospholipid content were observed. However, the ileal microvillus membrane in estradiol-treated animals demonstrates significant reductions vs. controls (per mg protein) in total lipid (0.55 milligrams vs. 0.89 milligrams) [corrected] and phospholipid (206.7 micrograms vs. 304.91 micrograms) (p less than 0.001) content, as well as modifications in specific phospholipid species. The increase in the ileal microvillus membrane cholesterol: phospholipid molar ratio (0.65 vs. 0.51, p less than 0.05) was associated with a significant decrease in membrane lipid fluidity reflected by an increase in fluorescence anisotropy measurements utilizing diphenyl hexatriene as the fluorophore (r at 25 degrees C = 0.306 vs. 0.282, p less than 0.05). Thermotropic lipid phase transitions, assessed by Arrhenius plots of both fluorescence data and ileal microvillus membrane p-nitrophenylphosphatase activity demonstrate that phase changes occur between and 24 and 28 degrees C in both treated and untreated groups. Within the temperature range studied (40-10 degrees C) no differences from control were observed in microvillus membrane alkaline phosphatase activity following estrogen treatment. These data therefore indicate that ethinyl estradiol-induced effects on microvillus membrane lipid composition and physical properties occur predominantly in the ileum and appear to be related, in part, to specific alterations in the availability of phospholipid following estrogen treatment.

4-Nitrophenylphosphatase↗
PubMed2003

Pentagastrin-induced release of free fatty acids in healthy volunteers and patients with panic disorder: effect of pretreatment with ethinyl estradiol.

OBJECTIVE: The primary objective of this study was to assess whether pentagastrin-induced panic symptoms are associated with release of free fatty acids (FFAs) in a manner that could explain the mechanism of correlations observed between serum cholesterol levels and frequency and severity of panic attacks in patients with panic disorder (PD). A secondary objective was to assess whether pretreatment with ethinyl estradiol (EE) attenuates pentagastrin-induced release of FFAs. METHODS: A double-blind, crossover, placebo-controlled study was conducted in which patients with PD and healthy volunteers received 2 injections of pentagastrin, 7-10 days apart, with randomization of the order of pretreatment with placebo and EE. RESULTS: We found a statistically significant, time-dependent release of FFAs in response to pentagastrin challenge. However, this release of FFAs was not attenuated by pretreatment with EE. CONCLUSIONS: These results support the hypothesis that release of FFAs in association with panic attacks occurs in a manner similar to the stress-induced lipolysis model. This suggests a possible mechanism for the elevated serum cholesterol levels observed in patients with PD. However, the occurrence of a delayed increase in low-density lipoprotein (LDL) cholesterol following induction of a panic attack remains to be tested in studiesincorporating a placebo injection visit and timed measurements of LDL cholesterol.

Adult↗
PubMed1977

High inhibitory activity of a new antiestrogen, RU 16117 (11alpha-methoxy ethinyl estradiol), on the development of dimethylbenz(a)anthracene-induced mammary tumors.

From the first day of dimethylbenzanthracene administration, daily treatment with 8 or 24 mug of the new antiestrogen 11alpha-methoxy ethinyl estradiol (RU 16117) completely prevented the appearance of mammary tumors in all animals up to the last time interval studied (130 days after dimethyl benzanthracene administration). At daily doses of 0.5 and 2.0 mug RU 16117, the tumor incidence was reduced to 78.6 and 40%, respectively. Not only was the number of animals developing tumors reduced after injection of low doses of RU 16117, but the number of tumors per rat and the size of tumors were also markedly reduced. The levels of receptors for estradiol, progesterone, and prolactin in tumor tissue were reduced after treatment with 2.0 mug RU 16117, while the binding of growth hormone and insulin was not affected. Whereas plasma luteinizing hormone levels decreased after treatment with 8 or 24 mug RU 16117, plasma prolactin levels slightly increased in animals receiving the highest dose of the antiestrogen. It is thus likely that the potent inhibitory effect of RU 16117 on the development of dimethylbenzanthracene-induced mammary tumors results from actions at both the hypothalamic-pituitary and the tumor (mammary gland) levels, the action at the peripheral level possibly being secondary to a reduced sensitivity of the tissue to circulating hormones through lowering of hormone receptor concentrations.

9,10-Dimethyl-1,2-benzanthracene↗
PubMed2003

Efficacy, safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol.

This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN (NGM 180/215/250 microg/EE 35 microg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN Lo (NGM 180/215/250 microg/EE 25 microg), one of three cyclophasic regimens (NGM cycling 180-250 microg/EE 35 microg or 25 microg) or ORTHO TRI-CYCLEN. Among all five regimens, ovulation suppression, cycle control and safety were generally comparable. Presumed ovulation (serum progesterone levels >or=3 ng/mL during Days 19-21 of Cycle 3), occurred in 0/41 (0%) subjects on ORTHO TRI-CYCLEN Lo and 3/43 (7%) subjects on ORTHO TRI-CYCLEN. Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN. The mean number of days of BBS/cycle for ORTHO TRI-CYCLEN Lo and ORTHO TRI-CYCLEN was 3.7 and 3.1, respectively, for those subjects with such bleeding. Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control.

Adolescent↗
PubMed1980

Effects of 17 alpha-ethinyl estradiol on the serum lipoproteins of cholesterol-fed diabetic rats.

Large doses of 17 alpha-ethinyl estradiol were administered to rats made diabetic by administration of streptozotocin and fed a diet containing 2% cholesterol and 1% cholic acid. Before estrogen treatment, these rats were severely hypercholesterolemic and had high concentrations of lipoproteins of d < 1.006 g/ml (very low density lipoproteins, VLDL), d = 1.006 to 1.03 g/ml (intermediate density lipoproteins, IDL), and d = 1.03 to 1.063 g/ml (low density lipoproteins, LDL), and low concentrations of lipoproteins of d = 1.063 to 1.21 g/ml (high density lipoproteins, HDL). The VLDL contained two populations of particles with a mean diameter of 1150 and 350 A, respectively. The IDL contains only the latter particles. These particles are unusual in that they contain apolipoprotein A-I in addition to their usual complement of apolipoproteins. After estrogen treatment, the concentrations of both large and smaller particles in VLDL were greatly decreased as were the concentrations of IDL and LDL; apo A-I was no longer present in the residual VLDL and IDL. HDL phospholipid, protein, and cholesterol increased 7-fold, 4-fold, and 2-fold, respectively. Studies by others have shown that large doses of estrogen enhance uptake of LDL by the liver and this is associated with an increase in the saturable binding sites for LDL on liver membranes. The present studies suggest that these binding sites recognize lipoproteins other than LDL. Furthermore, the enhanced uptake of these lipoproteins appears to result in transfer of their surface components to HDL.

Animals↗
PubMedDate not supplied

Ethinyl estradiol and medroxyprogesterone treatment in advanced breast cancer: a pilot study.

Twenty patients with disseminated breast cancer unresponsive to conventional chemotherapy and chemohormonotherapy were treated with an alternating sequential schedule of ethinyl estradiol and medroxyprogesterone on the basis of correlations between hormones and estrogen and progestin receptors. Of 19 evaluable patients, six underwent partial or complete remission, while five others showed minor responses.

Breast Neoplasms↗
PubMed1993

Hemostatic and metabolic effects of lowering the ethinyl-estradiol dose from 30 mcg to 20 mcg in oral contraceptives containing desogestrel.

The metabolic and hemostatic effects of two oral contraceptives containing 150 mcg desogestrel and 20 mcg ethinyl-estradiol (EE) (MERCILON) or 30 mcg EE (MARVELON) were compared in order to examine the effect of reducing the EE dose in contraceptive pills. Forty-nine women participated in this randomized study during 6 cycles. In both groups, there was a significant increase in triglycerides, HDL-cholesterol and apoprotein A1; the same increase was observed for SBP and CBG. Slight and transient variations of fasting blood glucose levels were seen in the 30 mcg EE group and in the two groups for fasting insulin levels. The increase in renin substrate was significantly higher with the 30 mcg EE than with the 20 mcg EE pill. In both groups, plasminogen increased significantly, but antithrombin III, total and free protein S and fibrinogen decreased significantly only in women taking the 30 mcg EE pill, whereas there was no significant change in the 20 mcg EE group. Reducing the dose of EE in oral contraceptives from 30 mcg to 20 mcg minimizes their impact on renin substrate and hemostatic parameters.

Apolipoprotein A-I↗
PubMed1985

Effect of combined ethinyl estradiol and norgestrel oral contraceptives on hepatic functions of albino rats.

The effect of two different doses of ethinyl estradiol and norgestrel combined oral contraceptives (OCs) on hepatic functions of albino rats was studied for a period of six months. Combined OCs treatment caused an increase in glycogen, RNA, total lipids, triglycerides, cholesterol and free fatty acids contents of liver and liver microsomes and decreased the liver weight/body weight ratio and phospholipid contents. Liver aminotransferase activities were elevated in the OCs treated animals whereas alkaline phosphatase activity remained unchanged. The biochemical changes were found to be dose dependent. Thus the present study has shown that the combined OCs treatment for six months is associated with altered hepatic functions. The possible mechanism of such an alteration of hepatic functions on OCs treatment is discussed.

Animals↗
PubMed2000

Vaginal bleeding in postmenopausal women taking low-dose norethindrone acetate and ethinyl estradiol combinations. The FemHRT Study Investigators.

OBJECTIVE: To determine the effect of continuous combined treatment with norethindrone acetate and ethinyl estradiol (E2) on vaginal bleeding, spotting, or bleeding and/or spotting in postmenopausal women. METHODS: Two randomized clinical trials were conducted in which participants recorded information on the daily occurrence of vaginal bleeding or spotting. In study 1, 219 postmenopausal women reporting at least ten hot flushes per week were randomized to placebo or one of four treatment groups (0.2 mg norethindrone acetate/1 microg ethinyl E2, 0.5 mg norethindrone acetate/2.5 microg ethinyl E2, 1 mg norethindrone acetate/5 microg ethinyl E2, or 1 mg norethindrone acetate/10 microg ethinyl E2). In study 2, 266 postmenopausal women reporting at least 56 moderate to severe hot flushes were randomized to placebo or one of three treatment groups (0.5 mg norethindrone acetate/2.5 microg ethinyl E2, 1 mg norethindrone acetate/5 microg ethinyl E2, or 1 mg norethindrone acetate/10 microg ethinyl E2). The total duration of treatment was 16 weeks in study 1 and 12 weeks in study 2. In both studies, subjects reported in daily diaries whether they had either bleeding or spotting. RESULTS: In study 1, there was a significantly greater relative risk (RR) for bleeding in the group receiving 1 mg norethindrone acetate/10 microg ethinyl E2 at study weeks 4 and 8 (RR = 1.36 and 95% confidence interval [CI] 1.01, 1.83; RR = 1.37 and 95% CI 1.1, 1.72; respectively) compared with placebo, but not at study weeks 12 or 16. The group receiving 1 mg norethindrone acetate/5 microg ethinyl E2 also had a significantly greater risk at weeks 4 and 8 (RR = 1.5 and 95% CI 1.15, 1.96; RR = 1.33 and 95% CI 1.00, 1.77; respectively), whereas the other dose combinations did not differ from placebo. Results from study 2 were similar to those of study 1. CONCLUSION: Although there was a greater risk for bleeding and/or spotting at the higher doses of norethindrone acetate and ethinyl E2, this risk declined over time. If compliance with hormone replacement therapy regimens is influenced at least in part by vaginal bleeding, the combined norethindrone acetate/ethinyl E2 regimen investigated in these studies may provide a treatment option.

Adult↗
PubMed1992

The effect of ethinyl estradiol on endometrial thickness and uterine volume during ovulation induction by clomiphene citrate.

OBJECTIVE: To assess the deleterious effect of clomiphene citrate (CC) on the development of the endometrium and its improvement by the addition of ethinyl estradiol (E2). PARTICIPATING PATIENTS: Infertility-treated patients, monitored for induction of ovulation or timing of insemination (control group). DESIGN: We studied four groups of women during an ovulatory cycle with various treatment schedules. Group 1: untreated patients; group 2: patients treated by CC; group 3: patients treated by CC + ethinyl E2; group 4: patients treated by human menopausal gonadotropin. Follow-up of the patients was done by vaginal ultrasonography and measurements of blood E2. RESULTS: In the group treated by CC, both endometrial thickness and uterine volume growth during the follicular phase were lower as compared with untreated controls and menotropin-treated patients. The addition of ethinyl E2 to these patients reversed this deleterious effect of CC without interfering with ovulation. CONCLUSION: Ethinyl E2 may reverse the deleterious effect of CC on endometrial development during the follicular phase.

Adult↗
PubMed1976

[Comparative studies on oral glucose tolerance and serum lipids under the influence of a new oral contraceptive (SH B 209 AB: 2 mg cyproterone acetate + 0.05 mg ethinyl estradiol), the combination D-norgestrel/ethinyl estradiol and in a control group (author's transl)].

24 healthy women given the combination of cyproterone acetate (2 mg) + ethynyl estradiol (0.05 mg) [SH B 209 AB] and D-norgestrel (0.25 mg) + ethinyl estradiol (0.05 mg) [Neogynon] were compared with a control group in oral glucose tolerance tests. The volunteers were divided into three groups. Two received alternately both preparations with each treatment cycle preceded by one cycle without medication. The third group served as an independent control. On the 25th day of each cycle blood was withdrawn before and 15, 30, 45, 60, 90 and 120 min after the carbohydrate load. Blood glucose and insulin and free fatty acids in serum were determined. Fasting values of triglycerides and cholesterol in serum were determined. The following results were obtained: 1. The mean fasting levels of blood glucose, serum insulin and free fatty acids were unchanged. 2. The total area under the blood glucose curve over the initial value was not altered 2 h after treatment with SH B 209 AB or Neogynon. The total area under the insulin and free fatty acids curves were also unchanged after the oral glucose load. 3. There was no change in serum cholesterol. 4. Serum triglycerides were significantly increased after SH B 209 AB. 5. The implications of the structural differences between both gestagens are discussed.

Blood Glucose↗
PubMedDate not supplied

[Changes in the activity of enzymes of cholesterol esters synthesis and hydrolysis in rat adrenals after treatment with 17 alpha-ethinyl estradiol].

A study was made of the effect of hypocholesterolemia induced by 3-day administration of 17 alpha-ethinyl estradiol on the activity of lysosomal and cytoplasmatic cholesterol esterases, acyl-CoA: cholesterol acyltransferase and on the free and esterified cholesterol concentrations in the rat adrenals. A decrease in the content of esterified cholesterol in the adrenal tissue was accompanied by a decrease in the activity of acyl-CoA: cholesterol acyltransferase and by an increase in the activity of lysosomal cholesterol esterase. The activity of cytoplasmatic cholesterol esterase was not changed significantly. The data obtained were discussed with relation to the synthesis of steroid hormones in the rat adrenals.

Adrenal Glands↗
PubMed1975

Clinical experience with ethinyl estradiol and d-norgestrel as an oral contraceptive.

One hundred eighty-one women received 30 mug of ethinyl estradiol plus 150 mug of d-norgestrel as an oral contraceptive for 21 days and then received no tablets for the next seven days for a total of 1,488 cycles. There were no pregnancies. Cycle control was good to excellent. Menstrual cycles lasted 25 to 32 days in 96.2% of treatment cycles. Menstruation lasted three to five days in 93.2% of the cycles, and it began three to five days after the last day of medication in 79.1%. The menstrual flow was moderate in 87%. Breakthrough bleeding occurred in 2.0% of treatment cycles, spotting in 0.1%, and amenorrhea in 0.8%. The incidence of adverse subjective symptoms was minimal and significant increases compared with the pretreatment cycle were noted only for nausea in the first two cycles and for nervousness in the second cycle of treatment. Overall incidence of nausea was 3.2% of treatment cycles.

Adolescent↗
PubMed2006

Effect of a combined oral contraceptive containing 20 microg ethinyl estradiol and 75 microg gestodene on hemostatic parameters.

The effects of a combined oral contraceptive (COC) containing 20 microg ethinyl estradiol (EE) and 75 microg gestodene (GSD) on prothrombin activity (PA), activated partial thromboplastin time (APTT), thrombin time (TT), platelet number, fibrinogen, antithrombin III (ATIII), protein C, protein S and D-dimer were evaluated over 6 months in 23 young, healthy women. Laboratory assessments were performed prior to initiation of COC use (pretreatment) and after 3 and 6 months of use. Results showed no significant changes in fibrinogen, protein C, ATIII or D-dimer during COC use, compared with pretreatment values. The increase in platelet count, decreases in protein S level, PA and APTT, and the prolongation of TT were significant. In conclusion, the use of a COC containing 20 microg EE and 75 microg GSD did not cause any significant changes in the hemostatic parameters studied that could be suggestive of a higher prothrombotic risk. Further studies with a larger sample size are necessary in order to obtain conclusive data.

Adolescent↗