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This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

During 1989-90 there were a total of 3,475,862 prescriptions of oral contraceptives (OCs) made in Australia by general practitioners. A 2- sided insert to facilitate deciding on the proper dosage for patients with various conditions was developed containing the estrogen- progestogen doses of OC preparations, management of minor side effects (nausea, vomiting, weight gain, chloasma, breakthrough bleeding, breast tenderness, or acne), and the relative contraindications to OC use. The simple, user-friendly, and flexible flow chart contains relative contraindications: age over 35 in heavy smokers, migraine or severe vascular headache, age over 45, previous cholestasis during pregnancy, hypertension, smoking, diabetes mellitus, long term immobilization, abnormal vaginal bleeding, gallbladder disease, impaired liver function, acute infectious mononucleosis, and use of rifampin or anticonvulsants.
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PMID:Prescribing oral contraceptives and the medical record. 179 98

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

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

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

The efficacy and safety of buserelin acetate in the treatment of endometriosis was studied in 4 open non-comparative trials and 2 open randomized comparative trials with danazol. 444 women were enrolled in the buserelin group and 89 in the danazol group. Treatment was for 6-10 months using 900-1200/micrograms intranasal buserelin/day and 400-800/micrograms oral danazol/day; patients were followed up for 6-8 months. Endometriotic lesions improved or disappeared in most women; pain (dysmenorrhoea, dyspareunia and pelvic pain) subsided rapidly. Most women had no, or alleviated, symptoms throughout follow-up, although ovarian function resumed promptly. Nearly a quarter of infertile women with a desire for children became pregnant. No significant differences between treatments emerged. Buserelin treatment was characterized by menopausal-like symptoms in most women, as well as by headache and nausea. Danazol treatment, which also gave rise to these effects, was accompanied by weight gain, myalgia and acne in a considerable proportion of women, as well as other anabolic and androgenic side effects. Buserelin would thus appear to be a safe and effective alternative to the standard therapy, danazol, in the treatment of endometriosis.
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PMID:Efficacy and safety of intranasal buserelin acetate in the treatment of endometriosis: a review of six clinical trials and comparison with danazol. 210 46

The effects of ketoconazole, a synthetic imidazole derivate, were evaluated in 42 women affected by acne (17 cases) and/or hirsutism (36 cases) treated with 400 mg/day for 3-6 months. Androstenedione, total and free testosterone, 5 alpha dihydrotestosterone and dehydroepiandrosterone levels progressively dropped during treatment while 17 alpha hydroxyprogesterone, estradiol, ACTH, cortisol, LH and FSH levels increased. Dehydroepiandrosterone sulfate decreased only towards the end of treatment, while estrone, sex hormone binding globulin, and PRL remained unchanged. Daily mean +/- SD rate of hair growth, measured by a special image analysis processor, decreased within 3 months of therapy from 0.258 +/- 0.058 to 0.184 +/- 0.039 mm/day (P less than 0.02) and mean +/- SD hair diameter from 0.123 +/- 0.015 to 0.110 +/- 0.013 mm (P less than 0.05) together with decreasing hormone levels. The therapeutic effects of ketoconazole on hirsutism was evident at 6 months in only 14 subjects, while no significant change in hirsutism score was recorded in 22 women who failed to complete the therapy. Acne improved in all cases. Several side effects and complications arose during treatment, such as headache, nausea, loss of scalp hair, hepatitis, and biochemical changes. Even though ketoconazole improves hyperandrogenism, only selected patients are eligible for treatment as scrupulous monitoring is required.
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PMID:Ketoconazole therapy for women with acne and/or hirsutism. 216 69

Gestoden is a gestagen from the 19-nortestosterone series. It has the strongest gestagen effect of any of the known gestagens. This permits a very low dosage in oral contraceptives in which 75 mcg of Gestoden are combined with 30 mcg of ethinylestradiol. Gestoden differs from levonorgestrel only in the presence of a double bond in rind D of the steroid chain. This small difference, however, is associated with an improved affinity to the progesterone receptors by a factor of 3. Gestoden does not exhibit either an estrogen nor an antiestrogen effect which suppresses the undesired effects of estrogen on the endometrium and on the metabolism. In clinical tests the combination of 75 mcg of gestoden and 30 mcg ethinylestradiol were used in phase II and III clinical tests in 17 countries with nearly 8,000 women in 60,000 cycles. In an ongoing phase IV study data from 200,000 cycles in almost 38,000 women has been gathered. In all studies pregnancy was very rare, at about the same level as other low dose combination contraceptives. 5% of the cycles exhibited bleeding irregularities. In the 1st few cycles, nausea, breast tension, acne and edema occasionally occurred but decreased with continued usage. No clinically meaningful changes in lipid or carbohydrate metabolism were observed. Blood studies on 60 healthy women taking the gestagen mixture or 150 mcg desogestrel showed low values of antithrombin III in the 36th week of treatment. Thrombocyte aggregation increased markedly with both preparations but less with gestoden than with desogestrel.
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PMID:[Oral contraception with low-dose progestagen]. 265 58

28 patients with polycystic ovary syndrome were treated for 12 months with the new preparation SH B 209 AE, consisting of 0.035 mg of ethinyl estradiol and 2 mg of cyproterone acetate. This was the first clinical trial of estroprogestational therapy on a homogeneous sample of women with polycystic ovary syndrome. Endocrine findings indicated a significant decrease in all hormonal parameters, the invariableness of prolactinemia, a considerable increase in sex hormone binding globulin (SHBG) at the 6th treatment cycle examination, a continuous significant decrease in 17 beta E2 and androstenedione from the 6th to the 12th treatment cycles. In terms of clinical findings, there was a significant decline in the severity of acne, seborrhea, and hirsutism during drug administration. The menstrual cycle in the 28 study subjects remained under control during treatment, and there were no pregnancies. Side effects such as weight gain, nausea, headache, and changes in libido were not reported. Overall, the findings of this study suggest that administration of the new monophasic contraceptive association SH B 209 AE can normalize endocrine patterns in polycystic ovary syndrome and improve its androgenic symptomatology. The low content of estrogen, the changes in clinical and hormonal parameters, the low incidence of side effects, and the good control of the menstrual cycle provided by this treatment make SH B 209 AE deserving of more widespread application.
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PMID:A new association of ethinylestradiol (0.035 mg) cyproterone acetate (2 mg) in the therapy of polycystic ovary syndrome. 294 60

A 19 year-old woman complained of headache and nausea occurring while she was taking minocycline for acne. Examination showed bilateral papilloedema and a bilateral VIth nerve palsy. Symptoms and signs rapidly resolved after the drug was stopped. Benign intracranial hypertension due to tetracyclines is well known in infants. It is rare in adults. Its pathophysiology remains unknown. The role of vitamin A is inconsistent. Others biological factors or personal susceptibility could be involved.
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PMID:[Benign intracranial hypertension and minocycline]. 213 95


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