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Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) which contains 250 mcg norgestimate in combination with 35 mcg ethinyl estradiol (EE; Ortho-Cyclen or Cilest). 97 healthy women of childbearing age were part of this study; 37 received the new norgestimate/EE combination OC as primary therapy and 31 were switched over from the other OCs. The formulation was well-tolerated and was associated with excellent cycle control. After 6 cycles of use, there was no statistically significant difference in the incidence of spotting or breakthrough bleeding as compared with the baseline. Nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study as did systolic and diastolic blood pressures. Of particular interest was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/EE combination OC combines superior cycle with minimal risk of androgenic side effects.
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PMID:Clinical experience with a new norgestimate-containing oral contraceptive. 167 78

Health workers took blood samples from 41 black women living in the greater Harare area of Zimbabwe before they began taking a combines oral contraceptive (OC) with 30 mcg ethinyl estradiol and 150 mg desogestrel (Marvelon formulation) and 3, 6, 9, and 12 months after taking it to conduct metabolic tests. They also recruited 190 other black women from Harare and rural Chiweshe, Mazowe, and Domboshawa populations taking the same new generation progestogen-containing OC to determine the efficacy, acceptability, and safety of the OC. Only high density lipid (HDL) cholesterol levels rose considerably between pretreatment and 12 months (0.94-1.3 mmol/ml; p.05). Low density lipid (LDL) cholesterol levels remained basically the same. This accounted for the significant rise of the HDL cholesterol/LDL cholesterol ratio over 12 months from 0.41 to 0.61. Triglyceride levels did not rise significantly and always stayed within the normal range. No woman became pregnant during the clinical trial. 2% experienced minor side effects including backache, spotting, headache, and nausea. Body weight and blood pressure did not change significantly. Sociodemographic reasons accounted for the high dropout rate (60%). The leading reason was change of address since many women were migrant farm workers. Since HDL levels rose and LDL levels were the same, this OC appears to have a reduced risk of atherosclerosis and cardiovascular disease. The findings indicated that the Marvelon formulation OC did not adversely affect lipid metabolism and therefore did not increase the risk of atherosclerosis or cardiovascular disease among these women. It also effectively protected them from pregnancy and induced minimal side effects.
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PMID:Evaluation of a combined oral contraceptive pill in black Zimbabwean women. 180 54

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

The performance of a low-dose triphasic oral contraceptive (OC) in the first four cycles of use was evaluated by 1,326 primary-care physicians and specialists across Canada in a phase-IV postmarketing trial. Data were available from 5,460 women who completed 19,756 cycles of use with Synphasic. The incidence of intermenstrual bleeding characteristically decreased over the four cycles to 10% in women who were first-time users of OCs, to 14% in women who had previously used OCs but had discontinued use until this trial, and to 16% in women who had switched from another OC to Synphasic. The women reported a low incidence of headache, nausea, weight gain, breast complaints, and acne while receiving Synphasic. The results demonstrate good endometrial control with Synphasic and a high level of patient acceptance.
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PMID:Synphasic tablets in Canadian practice: a phase-IV multicenter study. 186 41

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

Contraceptives for teenagers are discussed in detail by type and appropriateness for teenagers, the role of nurses, and the nature of and approach to the client. Contraceptives included are oral contraceptives currently available (24 kinds) and contraindications, condoms, barrier contraceptives such as the diaphragm and sponges, spermicides, IUDs, periodic abstinence, morning after pills, and other methods. Because of the high rates of sexually transmitted diseases (STDS), the method recommended is the condom. There are reservations, however, because some teenagers may lack the maturity to use the condom reliably. When used in conjunction with a sponge or vaginal spermicide, protection against unwanted pregnancy is improved. Females may prefer oral contraceptives, which have the disadvantage of not protecting against STDs. The choices are many, however, and can be tailored to the needs of the client. The role of the nurse practitioner or nurses providing contraceptive advice is important because the information provided by many parents and school-based sex education courses is too little too late. Clients tend to be female and are placed in the position of needing to be more responsible for sexual behavior because males do not take responsibility. The stigma attached to planned sex is a deterrent to using contraceptive protection. The media are partly responsible for enhancing the image of unplanned passionate sex as being the most desirable in relating to a teenaged client, the nurse needs to establish rapport and seek a health history which includes questions about sexual behavior and birth control. Provide guidance so that choice is given, but also state a preference and the justification for its selection. Oral contraceptives (OCs), for example, are 95% effective for 1st year users. The 28-day regimen increases compliance because there is a pill for every day. Consistent time of use (within 4 hours of the time taken the preceding day) is important information to be stressed with the low-dose OCs. Norinyl 1/35 or OrthoNovum 1/35 is recommended for teenagers because of the low dose of estrogen and the good balance. When side effects occur, the balance needs adjustment. Minipills are suggested for lactating mothers or those with headaches, edema, or breast tenderness, but are also less effective. On the other hand, condoms have a failure rate of 9-12% for 1st year use, but increased skill effectiveness is increased. Use instructions are given.
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PMID:Contraceptives for teenagers. 191 98

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

Japan began oral contraceptive (OC) clinical studies after 1987 when the government requested studies of 2400 menstrual cycles and a minimum of 100 patients for 12 cycles and 20-30 patients for 24 cycles. 3 monophasic, 1 biphasic, and 4 triphasic drugs were tested from 6 companies and all contained ethinyl estradiol with different progestins (norethindrone, levonorgestrel, or desogestrel). In phase I, the purpose was to examine the pharmacological effects and shortterm safety of all 8 drugs among a small number of healthy volunteers and a comparison of results with Western women. Phase II was eliminated. Phase III involved examination of toleration of the drug, dropout rate, effects on cycle control such as bleeding patterns, metabolism, and effects on hormone secretion. In phase I, Ortho Novum 7/7/7 was administered at 3 dose levels for 1 menstrual cycle and the results were toleration and minimal side effects. Some experienced bleeding, spotting, and breakthrough bleeding. Suppression of ovulation was successful. In phase III, 40 medical schools, 174 hospitals, and 200 investigators enrolled 648 patients of which 117 withdrew. Interim results among women 22-42 years show no adverse effects either in self- reports or laboratory tests. There were nuisance side effects such as nausea, weight gain, and headache, and some amenorrhea and bleeding during different cycles. There is a high continuation rate and patient satisfaction. Results from the full sample are still pending.
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PMID:The current status of oral contraceptive clinical development in Japan. 257 51

2 cases reports are described of patients with renal artery stenosis who presented with hypertensive encephalopathy, normal blood pressures having been recorded within the previous 6 months while taking oral contraceptives (OCs). A 27-year-old woman, admitted to the hospital following 2 grand mal fits, had suffered from increasing headaches, nausea, and vomiting over the previous month. Her blood pressure had been elevated at 160/110 mmHg 1 week prior to admission but had been normal over previous 11 years while taking OCs (various formulations of combined estrogen and progestogen) which she had stopped taking 2 months previously. She was a nonsmoker. Her blood pressure was controlled with atenolol, nifedipine, and bendrofluazide, and her conscious level returned to normal with no further fits. An intravenous urogram revealed a small left kidney with a delayed nephrogram, and subsequent arteriography showed bilateral medial fibromuscular dysplasia with a narrow stenosis of the left renal artery. Attempted balloon angioplasty was unsuccessful due to arterial spasm. 4 months after presentation she became pregnant. Blood pressure was controlled with methyl dopa during pregnancy which progressed uneventfully to full term. In the 2nd case, a 19-year old girl became confused and suffered a grand mal convulsion. She had complained of headaches over the previous 3 days. Her blood pressure had been normal over the previous 6 months while taking Logynon (phased formulation of ethinylestradiol and levonorgestrel). She was a nonsmoker. On admission to the hospital, she suffered further generalized convulsions. Despite control of her convulsions with intravenous chlormethiazole, her blood pressure rose to 220/140 mmHg, and this was controlled with intravenous hydralazine and propranolol. The following day she was conscious and was changed to oral therapy. A renogram and DMSA scan showed normal sized kidneys, but there was evidence of decreased blood flow to the left kidney with an increased transit time. Renal arteriography showed a stenosis of the left renal artery, typical of intimal fibromuscular dysplasia, which was dilated by balloon angioplasty. Anti-hypertensive medication was withdrawn postoperatively, and her blood pressure has remained well controlled. In both of the cases the onset of hypertension was rapid with encephalopathy being the presenting feature. Hypertensive encephalopathy is well recognized as a presenting feature of renal transplant artery stenosis but not in cases of native renal artery stenosis. 1 of the patients had stopped using OCs 2 months before presentation, suggesting that although there may have been an association between OC use and the development of fibromuscular dysplasia, it could not be implicated in the mode of presentation.
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PMID:Encephalopathy in renovascular hypertension associated with the use of oral contraceptives. 311 27


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