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A comparison of the triphasic Triphasil and the combined oral contraceptive Diane 50 for treatment of acne for 6 cycles showed significant improvement in both groups. Triphasil (Wyeth-Ayerst) contains 50 mcg levonorgestrel and 30 mcg ethinyl estradiol, 75 mcg levonorgestrel and 40 mcg ethinyl estradiol for 5 days and 125 mcg levonorgestrel and 30 mcg ethinyl estradiol for 10 days. Diane 50 (Schering Ag) contains 2 mg cyproterone acetate and 50 mcg ethinyl estradiol for 21 days per cycle. 10 women in each group had physical, pelvic, ophthalmologic and neurologic exams, hematologic and biochemical screens, assays of free testosterone, sex hormone binding globulin (SHBG), androstenedione, dehydroepiandrosterone SO4 (DHEAS), progesterone, and computations of acne and hirsutism scores. Subjects had used tetracyclines, isotretinoin, erythromycin, topical clindamycin and benzoyl peroxide previously, but were withdrawn from medication in the cycle before the intervention. The mean acne scores, derived from grading and counting lesions and comedones, fell from 63.3 to 6 in the Diane 50 and from 64.2 to 4.5 in the Triphasil group. Subjective results were excellent for 6, good for 2 and unsatisfactory for 2 in the Diane 50 group, and excellent for 8 and good for 2 in the Triphasil group. In both groups mean free testosterone, androgen index, androstenedione and DHEAS, and an increase in SHBG were documented. 5 Triphasil and 5 Diane 50 subjects had increased cholesterol levels during the trial, the only abnormality detected. Side effects reported were recurrence of varicose veins and hemorrhoids in 1 women who withdrew, and complaints of mastalgia, nausea, dysmenorrhea, migraine, headache, backache and vaginal discharge.
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PMID:An open study of Triphasil and Diane 50 in the treatment of acne. 183 45

Results are presented of a phase 3 international multicenter trial to study the effect of a new, low-dose oral contraceptive (OC) containing 20 mcg ethinyl estradiol and 150 mcg desogestrel (Mercilon) with regard to efficacy, cycle control, blood pressure, and acceptability. In total, 1684 women from 12 European countries were included in the study. 4 pregnancies occurred, 3 of them patient failure and 1 tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects, i.e., headache, nausea, and breast tenderness, was already low after the 1st cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus far proven to be an effective, safe, and well-accepted ultra low-dose OC.
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PMID:Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol. 183 99

In view of the considerable debate concerning the possible failure of contraception in women taking broad spectrum antibiotics, the authors examined a group of 12 women ages 22-32 in a controlled study. Each had been on longterm therapy with oral contraceptives (OCs) containing ethinyl estradiol (EE) and levonorgestrel (Ng) for at least 6 months and all were in good general health. Blood samples were taken about 11.0 hours after dosing with OCs on days 5, 6, 7, and 8 of their contraceptive cycle, for measurement of EE2, Ng, FSH, and LH by radioimmunoassay. In addition, blood samples were taken on days 19, 20, and 21 of their contraceptive cycle for assay of progesterone concentrations in plasma. The study was repeated in the next cycle of OC use during which the patients took temafloxacin, a broad spectrum quinoline antibiotic in a dose of 600 mg twice daily for 7 days, beginning on day 1 of the cycle. All women completed the study satisfactorily as judged by diary cards, tablet counts, and plasma temafloxacin concentrations. In the early part of the study, some nausea and headaches were experienced; this was due to the taking of the drug on an empty stomach. When the antibiotic was administered with food, this problem was no longer a concern. There was no evidence of any interaction between temafloxacin and OCs. The plasma concentration of EE2 was 61.4 +or- 21.2 pg/ml in the control cycle and 68.5 +or- 26.6 pg/ml in the temafloxacin cycle. The plasma progesterone concentration was 0.53 +or- 0.1 ng/ml in the control cycle and 0.6 +or- 0.24 ng/ml in the temafloxacin cycle (p0.01). No woman demonstrated any significant rise in plasma FSH or LH concentrations during temafloxacin therapy. The authors conclude that there is no evidence for a systematic interaction between temafloxacin and OCs and that there is no need for use of alternative contraceptive methods in women taking OCs who are also being treated with temafloxacin.
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PMID:The lack of interaction between temafloxacin and combined oral contraceptive steroids. 190 91

Recently there have been reports that long-term use of estrogen- containing oral contraceptives (OCs) can induce folic acid and vitamin B deficiency which can lead to hematopoiesis. The symptoms are paleness, forgetfulness, sleeplessness, and euphoric and depressive states. This deficiency occurs when serum folic content falls below 8 nmol/1 or 3 ng/ml. According to a nutrition group blood folic acid level declined up to 40% in patients taking OCs. In a Sri Lanka study of healthy women aged 20-45 taking Ovulen 50 (.05 mg of ethinyl estradiol and 1 mg of ethynodiol diacetate) folic acid level dropped in the 1st 6 months stabilizing at 2.2 ng/ml in those from the lowest social classes and at 2.9 ng/ml in those from privileged classes. Prophylactic substitution of folic acid in the diet was recommended by WHO, but it is less effective since it appears in the diet as polyglutamate that has to be broken down to absorbable monoglutamate. A US study found that taking OCs for 60 months resulted in a 40% reduction of the vitamin B12 serum level, while vitamin B12 concentrations in erythrocytes and peripheral blood stayed normal. Vitamin B12 helps recover tetrahydrofolic acid from N-methyltetrahydrofolic acid. Possibly this is another manifestation of OC-induced folic acid hypovitaminosis. OCs can also influence tryptophan metabolism reducing its blood concentration whereby less 5-hydroxytryptamine (serotonin) is produced. This results in headache, concentration decreases irritability, and sleep disturbances. In addition, lower riboflavin (vitamin B2) and thiamin concentration in erythrocytes was reported after using OCs. Counseling on the possible effect on vitamin stores and on proper nutrition including folic acid as monoglutamate is necessary for women who use OCs or estrogen substitution therapy for postmenopause or for osteoporosis prophylaxis.
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PMID:[Folic acid and vitamin deficiency caused by oral contraceptives]. 192 42

From August 1988-June 1989, 983 physicians participated in a phase IV trial by following 7759 women using the monophasic oral contraceptive (OC), Demulen 1/35 (1 mg ethynodiol diacetate and 35 ug ethinyl estradiol) to evaluate its efficacy and safety. The total number of cycles for the study stood at 21,440. In addition, the total woman-years stood at 1787. Only 6382 patients could be evaluated for safety. 4.4% of the patients had adverse reactions to the OC, but only 1.7% of all patients stopped taking it. The leading side effects included nausea (67 cases), headache (45), amenorrhea (42), emotional changes (30), breast pain (19), dysmenorrhea (12), and 11 cases of weight gain, abdominal/pelvic pain, and bloating. Of the 280 reported adverse reactions, only 87 (31%) were considered severe. The leading serious adverse reactions were depression (10) and hypertension (6). Only 5412 patients could be used to determine efficacy. The physicians initially reported 121 (2.2%) pregnancies during the study. The researchers learned that 33 of the 84 returned 2nd questionnaires (response rate, 70%) reported that the women conceived after enrollment but before taking the OC. 36 conceived while taking it, but 8 did not take it daily. Noncompliance may have contributed to pregnancy for the remaining 28 cases. Therefore the 36 confirmed pregnancies made for a failure rate of .7%. 85.7% of the pregnancies happened in the 1st 3 months of taking the OC. Either patient noncompliance or true medication failure accounted for treatment failure. Therefore it is important for physicians to instruct patients on how to take OCs correctly.
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PMID:Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial. 204 81

Estrogen-related cardiovascular dysfunction was noted in 23 out of 30 patients with prostatic cancer (PC). Coronary subjects with PC suffered from cardiac pain evident on ECG necessitating correction by effective doses of coronary active drugs. PC patients with essential hypertension exhibited frequent headache, progressive edema of the legs, drastic hypertensive reactions. It is held that estrogen therapy for prostatic cancer should be preceded and monitored by therapeutic evaluation responsible for optimal conditions to prevent and early diagnose cardiovascular complications.
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PMID:[Diagnosis and therapeutic correction of changes in the cardiovascular system of patients with prostatic cancer treated with estrogens]. 208 39

Femovan contains 30 mcg of ethinyl estradiol and 75 mcg of gestodene. Gestodene has been used in combination oral contraceptives since 1987 in 38 countries with hardly any effect on carbohydrate and lipid metabolism or fibrinolysis. Its contraceptive reliability for menstrual cycle control and tolerance was examined. A total of 102.769 women aged 18-35 with 593.455 menstrual cycles were included in 2 phases. Most of the women were German women, but the study included women from Europe and Latin America. Although 2-8% of the women took Femovan irregularly, only 3 pregnancies occurred in 414 English women (4704 cycles), 7 in 3267 German women (36.711 cycles), and 124 in 95.906 German women (523.477) as a result of forgetfulness. The pearl index reached .16 and .22 in the 2 phases, respectively, under client failure, and .07 and .06 under method failure. Bleeding ranged from .6-2.8% of cycles, while spotting was 4.5-8.2%. The omission of menstrual bleeding occurred in less than 1% of this population. Tension in the breasts, headache, and nausea with nervousness occurred in up to 10% of the women. Nervousness, vertigo, and depression was significantly less frequent. Acne and edema occurred only in a few cases. The average increase of body weight was a maximum of .8 kg. Blood pressure was unchanged for a few cases. There were 2 and 26 cases, respectively, of thromboembolitic diseases in the 2 phases amounting to .3 and .6/1000 woman years of use which compares to .4-1.7/1000 of the Oxford-Family Planning Association cohort study results. Femovan was discontinued on medical grounds (headache, nausea, and irregular bleeding) in 10.3% of 3267 German women and in 7.5% of 95.906 German women. Femovan's acceptance rate was remarkably high, and it proved to reliable and well-tolerated.
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PMID:[Clinical experiences with femovan (Gynera)]. 209 80

Oral contraceptives (OCs, long-acting progestins (LAPs), and IUDS are reviewed in terms of new information on safety and efficacy. OC formulations are described and their mechanism of action and efficacy indicated. Reports are provided for thromboembolism, hemorrhagic and thrombotic stroke, ischemic heart diseases, alterations in lipid and hypoprotein and carbohydrate metabolism, hypertension, coagulation changes, breast and cervical cancers, and such minor side effects as menstrual irregularities, nausea, headaches, weight gain, premenstrual syndrome effects, and mood and libido changes. Noncontraceptive health benefits and clinical considerations are discussed. Norplant, as the only long acting progestin available in the US is described in terms of its formulations, mechanism of action, sequelae and metabolic effects, menstrual irregularities, metabolic effects, nuisance side effects, candidates for insertion, method of insertion and removal, and continuation rates. 2 IUD types are identified as the only ones available in the US, Progestasert T and T-Cu-380A (Paragard). Mechanism of action, efficacy, candidates, major sequelae such as salpingitis, infertility, and uterine perforation, minor sequelae such as metrorrhagia and dysmenorrhea, and other considerations are indicated. OCs in the US contain an average of 35 mg of ethinyl estradiol and assorted progestins e.g.s, ethynodiol diacetate, norethindrone acetate, nortestosterone derivatives with a complex mechanism of action. The failure rate for use effectiveness is 6 pregnancies/100 woman years. Modern formulations have combined rates of no more than 50 to 100 adverse events/100,000 users. Some of the effects are indicated as follows: Thromboembolism accounts for 60% of adverse effects and appears to be declining along with hemorrhagic and thrombotic stroke, however, modern use studies are only partially available. Myocardial infarction related to OC use may be embolic, and has a low risk at 7/100,000 users. Low-dose contraceptives substantially reduce the associated risks. Those with risk factors need close monitoring. Norplant is useful for those not wanting to take a daily regimen and is commonly accompanied by menstrual irregularity and sometimes headaches. Continuation is 80% after the 1st year and 40% after 5 years. Candidates for IUDs are parous women in monogamous relationships, who are not at risk for salpingitis, which is related to IUD use, or sexually transmitted diseases. Continuation is 70% after 1 year compared with 50% of OC users.
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PMID:Modern trends in contraception. 212 11

Clinical experience with Femovan (Schering AG, Berlin), a combined oral contraceptive containing 0.075 mg gestodene and 0.030 mg ethinyl estradiol, in 3267 women at 165 hospitals and private practices in Germany, from December 1985-February 1988, is presented. 46% were new pill users, 54% switched from other formulations, usually contained 0.030 mg ethinyl estradiol and levonorgestrel, desogestrel, norethisterone or lynestrenol. Each subject gave informed consent, was within 10% of normal weight, kept a menstrual diary, and attended for follow-up at 3, 6, 9, 12, 15 and 18 months. They averaged 24.7 years old. 98.7% continued for 6 cycles; 56.6% for 12 cycles and 33.4% for 18 cycles. While 90% of the dropouts did not return for follow up, stated reasons for stopping were 10.3% for minor side effects of headaches, intermenstrual bleeding and weight gain, and 8 for planned pregnancy. 7 pregnancies were recorded, 5 related to errors in taking tablets or 2 or more pills, giving a Pearl Index of 0.065 for method failure and 0.16 for patient failure. Both the flow and duration of menstrual bleeding tended to decrease. Intermenstrual bleeding occurred in 15.9% of new pill users, declining to 3.7% of all women by the 4th-6th cycles, often associated with omitted pills. There were no significant changes in weight or systolic or diastolic blood pressure. Numbers of complaints of minor side effects decreased or disappeared in 50-85%. Acne developed in 58 women but declined to 14 women after 12 cycles; acne pre-existed in 377 women improved in 41% after 3 cycles.
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PMID:Long-term experience with a low-dose oral contraceptive. 215 May 81

The therapeutic efficacy of the new triphasic contraceptive agent trisistone was evaluated in 42 women (20-35 years old) with various gynecological diseases. The group included 25 with uterine hemorrhage, 4 with post-castration syndrome, 4 with endometriosis, 4 with hypogonadism, and 5 with other diseases. The drug was dispensed monthly. The patients received 1 to 14 packages of trisistone (average number 3-4). The first phase consisted of 6 violet tablets containing 0.003 mg of ethinyl estradiol and 0.05 mg of levonorgestrel; the second phase consisted 6 pink tablets containing 0.04mg of ethinyl estradiol and 0.075 mg of levonorgestrel and third phase consisted of 9 orange tablets containing 0.03 mg of ethinyl estradiol and 0.125 mg of levonorgestrel. Of 42 patients, 16 had stopped taking the drug after the first cycle, while 26 showed clinical improvement. The treatment was the most effective in patients with estrogen and gestagen insufficiency, luteal insufficiency, and primary ovarian dysgenesis. Side-effects of trisistone included hemorrhage (9.5%), headache (7.1%), sensation of pregnancy (7.1%), dizziness (2.4%), and nausea (2.4%).
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PMID:[The use of the triphasic contraceptive preparation trisiston for therapeutic purposes]. 237 4


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