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PubMed1984

Conception control by vaginal administration of pills containing ethinyl estradiol and dl-norgestrel.

One hundred twenty-four women of reproductive age have used vaginal pills containing 50 micrograms dl-norgestrel and 35 micrograms ethinyl estradiol to prevent conception for periods ranging from 6 to 20 months. One thousand four hundred thirty-eight woman-months were recorded. No pregnancies occurred. Cycle control was good. Bleeding usually lasted 3 to 5 days, and the interval between withdrawal bleeding events was 26 to 30 days in 86% of the cycles. Amenorrhea, breakthrough bleeding, and spotting occurred rarely. The continuation rate at 1 year was 64%.

Adolescent↗
PubMed1987

Effects of cyproterone acetate (CPA) on serum lipoproteins when administered alone and in combination with ethinyl estradiol (EE).

The effects of serum lipids and lipoproteins of 2 mg cyproterone acetate (CPA) given alone and in combination with 35 or 50 micrograms ethinyl estradiol (EE) were studied in 21 oophorectomized women in a study with a cross-over design. CPA in this low oral dose was rather inert in its effects on lipoprotein lipids. It induced only a small decrease in the free cholesterol and phospholipid content of the high density lipoprotein (HDL) fraction. As regards the CPA-EE combinations, they induced a slight increase in the HDL fraction, a small decrease in the low density lipoprotein (LDL) fraction and a substantial increase in triglycerides both in the serum and in the very low density lipoprotein (VLDL) fraction. This lipoprotein pattern is invariably induced after the administration of an alkylated estrogen or an "estrogen dominated" oral contraceptive. An increase in triglycerides is a "biochemical" adverse effect which may have clinical implications for some patients.

Adult↗
PubMedDate not supplied

Tamoxifen versus ethinyl estradiol in the treatment of postmenopausal women with advanced breast cancer.

In a randomized study, 63 postmenopausal patients with advanced breast cancer were treated with ethinyl estradiol (EE2) or the antiestrogen tamoxifen to compare the efficacy and side effects of both drugs. EE2 was always given in combination with chlorothiazide to prevent fluid retention. Pretreatment characteristics of the patients of both groups did not differ significantly. Objective remissions were achieved in 31% of the EE2-treated patients and in 33% of the tamoxifen-treated patients. The median duration of remission was 12 months (range, 5-32) for the EE2 group and 11 months (range, 5-26) for the tamoxifen group (P greater than 0.1), and the estimated median survival times from the start of treatment were 31 and 25 months, respectively (P greater than 0.1). The best treatment results in both groups were obtained in patients with estradiol receptor-positive tumors and less advanced disease. After therapy was stopped, objective withdrawal responses were observed in EE2- but not in tamoxifen-treated patients. Two patients receiving EE2 had to discontinue treatment because of drug-related liver function impairment. Both patients had cholelithiasis. Two patients in the tamoxifen-treated group discontinued therapy because of nausea. Deep venous thrombosis occurred in one patient receiving EE2, whereas two patients receiving tamoxifen developed superficial thrombophlebitis. Other side effects in both groups of patients, including initial hypercalcemia, were mild. It is concluded that both treatment regimens, EE2 or tamoxifen, are equally effective with respect to induction and duration of remission in postmenopausal patients with advanced breast cancer. Side effects of EE2 therapy appeared to be more serious than those of tamoxifen treatment.

Adult↗
PubMed1986

Effect of cyproterone acetate-ethinyl estradiol treatment on the proportions of linoleic and sebaleic acids in various skin surface lipid classes.

The effect of high-dose cyproterone acetate-ethinyl estradiol treatment on rates of sebum secretion and on the proportions of linoleic acid (18:2 delta 9,12) and sebaleic acid (18:2 delta 5,8) in the skin surface lipids of three female acne patients was examined. Changes in rates of sebum secretion were evaluated indirectly by measuring the ratio of wax esters/(cholesterol + cholesterol esters) in the subjects' skin surface lipid. In two of the subjects, this ratio indicated a reduction of sebum secretion rates to the childhood range. Concomitantly, there was an increase in linoleic acid and a decrease in sebaleic acid in all lipid classes. In the third subject, in whom there was only a small reduction in sebum secretion rate, the proportion of linoleic acid in the cholesterol esters more than doubled, but the changes in the other lipid classes were small or nonexistent. The results indicate that the proportions of linoleic acid and sebaleic acid in sebum are influenced by sebum secretion rates.

Acne Vulgaris↗
PubMed2004

Clinical and metabolic aspects of the continuous use of a contraceptive association of ethinyl estradiol (30 microg) and gestodene (75 microg).

This open, prospective, noncomparative study evaluated clinical and metabolic aspects of the use of a contraceptive combination of ethinyl estradiol (30 microg) and gestodene (75 microg) continuously for 24 weeks in 45 women aged 25 +/- 3.7 years. No alterations in weight or blood pressure were observed. Few side effects were recorded. Amenorrhea rates increased from the fourth month of observation onwards, reaching 81.2% by week 24. A reduction in the levels of cholesterol and LDL and an increase in HDL and triglycerides were observed. Insulin levels increased but not significantly, while levels of glycemia remained unchanged. Levels of antithrombin III, fibrinogen and plasminogen activator inhibitor-1 (PAI-1) increased, whereas a reduction was observed in proteins C and S and in prothrombin time (PT). Activated partial thromboplastin time (APTT) remained unchanged. The treatment was associated with satisfactory clinical effects, high rates of amenorrhea after the third treatment cycle, and resulted in metabolic changes similar to those encountered during the classic use of contraceptive pills with monthly interruption for withdrawal bleeding.

Adolescent↗
PubMed1989

Induction and promotion of gamma-glutamyltranspeptidase-positive foci in the liver of female rats treated with ethinyl estradiol, clomiphene, tamoxifen and their associations.

The objective of the present study was to determine whether a short exposure (6 weeks) to high doses of ethinyl estradiol (EE) could not only promote but also initiate hepatocarcinogenesis, and whether two antiestrogens, clomiphene (C) and tamoxifen (T), could influence EE activity. 2-Acetylaminofluorene (AAF), which has been shown to produce rat liver hyperplastic lesions characterized by the presence of estrogen receptors, was used either as a promoter to test for initiating activity, or as an initiator to test for promoting activity. Putative preneoplastic lesions were identified by means of a positive gamma-glutamyltranspeptidase (GGT) reaction. The results revealed that when administered alone in female Sprague-Dawley rats, not only E, but also C and T were clearly active in both initiating and promoting the development of GGT-positive foci. Moreover, in rats of the same strain treated with EE + C or EE + T a significant increase in the incidence of GGT foci demonstrated the occurrence of an additive effect in terms of both initiating and promoting activity. Fischer 344 rats were more susceptible than Sprague-Dawley rats to promotion by EE, C and T, but any substantial evidence of an additive effect was absent when the two anti-estrogens were administered in association with the estrogen.

Animals↗
PubMed1981

The treatment of essential hirsutism in women with cyproterone acetate and ethinyl estradiol. Clinical and endocrine effects in 10 cases.

Ten women with essential hirsutism were treated for one year with cyclic administration of cyproterone acetate and ethinyl estradiol. Biochemical and clinical control took place after 1, 3, 6 and 12 months of treatment. In 4 patients great improvement of hirsutism was noted, but only after 6 months of therapy. In 4 patients there was some improvement, while 2 were resistant. Side effects included reduced libido in 4 cases, mental depression in 3, dry skin and itching in 4 and transient nausea in one, but never necessitated cessation or interruption of treatment. Several changes in endocrine function took place during treatment: testosterone secretion rate diminished together with the urinary excretion of 17-KS and 17-KGS, while the serum concentration of testosterone binding globulin increased. There was a reduction in the serum concentration of total endogenous estrogens and progesterone as well as LH. No changes in hepatic, renal or hematologic parameters were found except for a slight increase in plasma prothrombin time. Clinical outcome of therapy could not be correlated with a pretreatment endocrine "profile", nor with the changes that this therapy induced in endocrine function. It is concluded that the anti-androgenic effect is probably the most important in this drug regimen, but that reversibility of hirsutism may depend upon factors not directly related to androgen influence.

17-Hydroxycorticosteroids↗
PubMedDate not supplied

The treatment of cervical factor with ethinyl estradiol and human menopausal gonadotropins.

Previously we have demonstrated that one can significantly improve the cervical factor in cases that have failed with conventional therapy by employing high doses of estrogen to stimulate the cervical mucus glands. The patients are concomitantly treated with human menopausal gonadotropins to stimulate ovulation, because of endogenous gonadotropin suppression by the estrogen. Monitoring of the hMG is accomplished by pelvic sonography. Unfortunately, the serum estradiol assay cannot also be used because it would measure not only endogenous estradiol but also exogenous estradiol from the conjugated estrogens employed. A modification of this technique is described wherein the estrogen now used is ethinyl estradiol. This estrogen has very little cross-reactivity in the 17-beta-estradiol assay. Thus, both ultrasound and serum estradiol monitoring can be used, resulting in a safer and more effective technique.

Adult↗
PubMed1990

Comparative studies of 30 micrograms ethinyl estradiol combined with gestodene and desogestrel on blood coagulation, fibrinolysis, and platelets.

An association between an increase in the incidence of thromboembolic disease and the use of combined oral contraceptives has been shown by several epidemiologic studies. Evidence of the vascular complications of oral contraceptives suggests that venous thromboembolism correlates with estrogen dosage and arterial complications with both estrogen and progestogen components. In 60 healthy, randomly allocated women, the effects of ethinyl estradiol, 30 micrograms, combined with gestodene, 75 micrograms, and desogestrel, 150 micrograms, on blood coagulation, fibrinolysis, and platelet function were compared. Subjects were studied before oral contraceptive use, at 12, 24, 36, and 48 weeks of treatment, and at 6 and 12 weeks after treatment. Both oral contraceptives affected the hemostatic system, but our results indicate that the ethinyl estradiol/gestodene combination causes changes in the hemostatic system similar to those in the ethinyl estradiol/desogestrel combination. Factors VII and X activity were slightly higher with the ethinyl estradiol/desogestrel combination than with the ethinyl estradiol/gestodene combination, possibly reflecting a greater estrogenic effect.

Adolescent↗
PubMed2003

Effect of an oral contraceptive containing ethinyl estradiol and drospirenone on premenstrual symptomatology and health-related quality of life.

OBJECTIVE: To evaluate the effect of the oral contraceptive Yasmin (drospirenone, 3 mg, and ethinyl estradiol, 30 micrograms) (Berlex Laboratories, Wayne, New Jersey) on premenstrual symptomatology and health-related quality of life (HRQoL). STUDY DESIGN: Participating health care providers received 11,260 self-administered surveys for distribution to women initiating use of Yasmin. Of these, 1,932 (17.2%) baseline surveys and 1,104 follow-up surveys (57.1%) were returned, with 858 (44.4%) of the returns evaluated as suitable for analysis. RESULTS: Premenstrual symptomatology, as measured with the negative affect and water retention domains of the Moos Menstrual Distress Questionnaire (MDQ), significantly improved from baseline in all phases of the menstrual cycle (P = .000). All individual MDQ items improved significantly in the late luteal phase and during menses (P = .000), and the majority (76.9%) improved significantly in the remainder of the cycle (P < .05). Improvements were also observed in general sense of well-being (P < .05), impairment in usual activities due to premenstrual symptomatology (P < .05) and Mental Component Summary scale (P = .000) but not the Physical Component Summary scale of the Short Form-12 generic HRQoL instrument. CONCLUSION: These data support the effectiveness of Yasmin in reducing premenstrual symptomatology and improving HRQoL and general sense of well-being.

Adult↗
PubMedDate not supplied

Increased removal of beta-very low density lipoproteins after ethinyl estradiol is associated with increased mRNA levels for hepatic lipase, lipoprotein lipase, and the low density lipoprotein receptor in Watanabe heritable hyperlipidemic rabbits.

The mechanism by which ethinyl estradiol (EE) decreases the concentration of lipids in the d less than 1.019 g/ml fraction (beta-very low density lipoprotein [beta-VLDL]) of homozygous Watanabe heritable hyperlipidemic (WHHL) rabbits was studied. Treatment with EE increased the activity of hepatic lipase (HL) twofold to threefold in postheparin plasma and in liver biopsies. Postheparin plasma and adipose tissue lipoprotein lipase (LPL) activities were also increased twofold to fourfold after EE. The effects of EE on HL and LPL activities were associated with a threefold to sixfold elevation in liver HL mRNA and a fourfold elevation in adipose tissue LPL mRNA steady-state levels, pointing to an effect of EE on HL and LPL gene transcription. EE also increased liver low density lipoprotein (LDL) receptor mRNA levels threefold to fivefold. These results suggest a concerted action of LPL, HL, and the LDL receptor in the removal of beta-VLDL in homozygous WHHL rabbits with a defective LDL receptor. In addition, the content of apolipoprotein E in the d less than 1.019 g/ml fraction changed toward normal after EE. Because the remaining particles contained apolipoprotein B-100 almost exclusively, it is likely that apolipoprotein E-containing beta-VLDLs are preferentially removed. This may be the result of the increased activity of LPL and HL influencing the conformation of apolipoprotein E on the beta-VLDL particle in such a way that it is directly removed from the circulation, possibly by the induced LDL receptor.

Adipose Tissue↗
PubMed1992

[A clinical trial of a monophasic contraceptive preparation containing ethinyl estradiol and desogestrel].

A multicenter trial was conducted in 267 centers in Italy to evaluate the efficacy, acceptability and safety of a monophasic oral contraceptive containing 30 micrograms ethinyl estradiol and 150 micrograms desogestrel (Marvelon). 13,290 women were followed up for a total of 74,967 cycles. No pregnancies due to method failure were reported and only three because of patient failure. Cycle control was good. There was a decrease in the occurrence of irregular cycles and in the duration and amount of menstrual bleeding; the incidence of breakthrough bleeding and spotting was low. No severe side effects occurred and the incidence of minor complaints was generally lower during treatment than in the pretreatment cycle. Body weight and blood pressure were not significantly altered.

Adult↗
PubMed1988

Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel.

A clinical trial was conducted at 47 centers in 11 countries to assess the efficacy and acceptability of a monophasic oral contraceptive containing 30 micrograms ethinyl estradiol and 150 micrograms desogestrel. 1,613 women took part for a total of 23,258 cycles. One pregnancy occurred in a cycle where two consecutive tablets had been forgotten. Cycle control was excellent, with reported decreases in the duration and amount of withdrawal bleeding during consecutive treatment cycles and a low incidence of irregular bleeding. Blood pressure was not affected during 2 years of use. The incidence of minor side effects was already low in the first treatment cycle and decreased further in the subsequent cycles. The combination (Marvelon) was shown to be a very reliable and acceptable oral contraceptive.

Adult↗
PubMed1989

Treatment of advanced endometrial adenocarcinoma with cyclic sequential ethinyl estradiol and medroxyprogesterone acetate.

Fifteen patients with recurrent or progressive endometrial adenocarcinoma of moderate to poor histologic differentiation were entered in a phase II trial of sequentially administered oral ethinyl estradiol and medroxyprogesterone acetate. There were no significant clinical responses in 12 patients evaluated for response and four patients experienced thromboembolic complications. This cyclic treatment regimen is considered ineffective for this patient population at the dosages and schedules used.

Adenocarcinoma↗
PubMed1992

A multicenter efficacy and safety study of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol.

The study reported herein is the primary efficacy and safety study conducted to support U.S. registration of an oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol. A large multicenter study enrolled 1,221 women at 50 centers in the United Kingdom. A total of 11,656 cycles of exposure was accumulated, corresponding to approximately 879 women-years of use. Contraceptive efficacy was high; no subject conceived as a result of method failure. The product was generally well tolerated with excellent cycle control, causing fewer than 2% of the subjects to discontinue because of bleeding irregularities. The study medication demonstrated no adverse effects on cervical cytology, blood pressure, body weight or laboratory variables, while pre-existing benign breast disease generally improved. The study did not identify any medication-related adverse experiences. This study confirmed that the monophasic oral contraceptive with 150 micrograms desogestrel and 30 micrograms ethinylestradiol is a safe and effective oral contraceptive with excellent cycle control and patient acceptability.

Adolescent↗
PubMed1999

Cycle control with oral contraceptives containing 20 micrograms of ethinyl estradiol. A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 micrograms/20 micrograms) and norethindrone/ethinyl estradiol (1000 micrograms/20 micrograms).

A randomized, open-label, multicenter study was undertaken to compare the effects of oral contraceptives (OC) containing 100 micrograms levonorgestrel (LNG)/20 micrograms ethinyl estradiol (EE) (Aless/Loette) and 1000 micrograms norethindrone acetate (NETA)/20 micrograms EE (Loestrin Fe 1/20) on menstrual cycle control over four cycles of use. A total of 84 evaluable women provided 274 cycles of exposure in the LNG/EE group, and 89 women provided 289 cycles of exposure in the NETA/EE group. Overall, the LNG/EE group achieved a consistently higher percentage of normal menstrual cycles as well as a lower rate of intermenstrual bleeding and amenorrhea than the NETA/EE group. In cycle 4, 63.8% of cycles were normal in the LNG/EE group compared with 41.9% in the NETA/EE group (p < 0.005). Of the total cycles in the NETA/EE group, 10% were amenorrheic, compared with 1.1% in the LNG/EE group. The occurrence of bleeding and/or spotting was significantly lower in cycles 2 and 3 in the LNG/EE group (41.7% and 34.8%, respectively) compared with the NETA/EE group (62.3% and 56.3%; p < 0.05). Other cycle variables were generally similar between groups, as was the incidence of adverse events. These results demonstrate that good cycle control was achieved with an OC containing 20 micrograms EE and that 100 micrograms LNG/20 micrograms EE produces better cycle control than 1000 micrograms NETA/20 micrograms EE.

Contraceptives, Oral, Hormonal↗
PubMed1995

Dirithromycin increases ethinyl estradiol clearance without allowing ovulation.

OBJECTIVE: To use a novel, sensitive study design to detect a potential oral contraceptive (OC) and dirithromycin drug interaction by assessing the pharmacokinetics of the ethinyl estradiol (E2) component of a common OC and the potential failure of OC effectiveness. METHODS: In this nonblinded study, 20 healthy women using Ortho Novum 7/7/7-28 were selected for a three-OC-cycle study. Baseline measures included E2 and progesterone serum levels on days 21, 23, 25, and 27 of cycle one and days 1, 3, 5, and 7 of cycle two. During cycle two, 24-hour blood sampling and radioimmunoassay analysis for ethinyl E2 pharmacokinetics were performed on day 8 and pelvic ultrasound on day 13. Oral dirithromycin 500 mg/day for 14 days began on day 21 of cycle 2. After starting dirithromycin, cycle two and three serum E2, progesterone, and serial ethinyl E2 levels and pelvic ultrasound replicated the baseline schedule. Ovulation was assumed if E2 concentration was greater than 50 pg/mL, progesterone concentration was greater than 3 ng/mL, or if an ovarian cyst greater than 10 mm was present on ultrasound. RESULTS: Pharmacokinetic analysis demonstrated a small (7.6%) but statistically significant decrease (P = .03) in the mean ethinyl E2 24-hour area under the curve and an increase in apparent oral clearance. No woman ovulated, based on E2 levels and progesterone concentrations or ultrasound. CONCLUSION: Dirithromycin increased the apparent oral clearance of ethinyl E2. The clinical importance of the interaction may be negligible because no woman ovulated or had compromised OC effectiveness in this small series.

Adolescent↗