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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had used tetracyclines, isotretinoin, erythromycin, topical clindamycin and benzoyl peroxide previously, but were withdrawn from medication in the cycle before the intervention.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

Sustained released progestin-containing subdermal implants, the first new contraceptives to be released in 30 years, have the advantages of being easy to use, completely reversible, highly effective, and free of some of the health risks associated with combined oral contraceptives. The Norplant implant system, consisting of 6 levonorgestrel-filled silastic capsules, is being used by more than 500,000 women around the world and was approved for use in the US in late-1990. Because Norplant does not contain estrogen, it can be used safely by women with elevated blood pressure or a history of thromboembolic disease. Clinical trials have revealed first-year continuation rates of 76-90% compared with 50% for the pill. The most common reasons for requesting removal of Norplant are menstrual irregularity (prolonged menstrual bleeding, spotting between periods, or amenorrhea), headache, and weight gain. Plasma levonorgestrel concentrations are below contraceptive levels within 48 hours of removal, and most women resume normal ovulatory cycles during the first month after method discontinuation. Studies of carbohydrate metabolism, liver function, blood coagulation, immunoglobulin levels, serum cortisol levels, and blood chemistries have failed to reveal significant alterations in Norplant acceptors. Although some studies have recorded reductions in cholesterol, and triglyceride levels, lipoprotein levels return to pretreatment values by the end of the first year of use. Biodegradable implants that eliminate the need for surgical removal and implants that provide contraceptive protection for only 1-2 years could further increase the affordability and acceptability of this method. Under development are the Capronor and norethindrone/cholesterol pellet systems, both of which are shorter term and biodegradable.
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PMID:Subdermal progestin implant contraception. 190 16

Many recent advances in fertility control have involved progestin-only contraception. The progestin-only oral contraceptive, which has a failure rate of 1-2.5%, is especially suited to women who are breastfeeding or cannot tolerate estrogen. The levonorgestrel implant, Norplant, is effective for 5 years and has a 1.5% failure rate. Currently under development is Norplant-2--a system that requires 2 rather than 6 capsules, lasts for 3 years, and is as effective as Norplant-1. Also under development is a biodegradable progestin-only implant. However, there are many side effects associated with these methods. Irregular bleeding occurs in 60-70% of Norplant acceptors and leads 12-20% of these women to discontinue implant use. Headaches and acne occur in 5-20% of users of levonorgestrel methods. More significant are concerns that progestin tends to increase low density lipoprotein levels. Although initial human trials have indicated a drop of 5-15% in both these levels, studies in macaque monkeys have found that progestin-only contraception is more likely to cause atherosclerosis than an estrogen-progestin formulation.
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PMID:Progestin-only contraception. 202 98

An 18-year old patient bearing a subcutaneous Norplant implant in the left upper arm for 2 years visited a gynecological clinic. The implant rods were removed under local anesthesia because of the increasing pigmentation of the skin, and she switched to oral contraceptive use. Norplant contains a total of 216 mg of levonorgestrel (LNG) in 6 silastic rods, each 3.4 cm long. Norplant-2 consists of 3 rods with a length of 4.4 cm providing a total of 140 mg of LNG. It has been in use since 1974 in Chile, and subsequently in Brazil, Indonesia, Thailand, Africa, and to a lesser extent in Scandinavia. It works via the continuous release of 30-50 mcg doses of progesterone daily that induces cervical mucous changes whereby sperm penetration is thwarted; nidation does not occur, and ovulation is also often inhibited. The Pearl-Index reaches .1-1.1 in the first 5 years of use. The most important side effects are menstruation changes (oligo- and amenorrhea), weight gain, and headache. The continuation rate is similar to that of the IUD: 95% through the 1st year of use, and 75% through 3 years reported from Chile and China. Reversibility is a major advantage: 50% of women become pregnant within 3 months after removal, 86% within 1 year, and 93% within 2 years. In the Netherlands sits acceptance is clearly distinct from prevalence in Chile and China, and it has only a minor role in applicability when other contraceptives fail.
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PMID:[Norplant in The Netherlands]. 210 35

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

Norplant offers long-term contraception through the use of subdermal capsules filled with levonorgestrel. The 6 capsules are implanted in the inside part of the upper arm. The levonorgestrel is released from the capsules gradually, providing contraception for about 5 years. The primary mechanism of action of Norplant is suppression of ovulation. Studies have shown a pregnancy rate of 0.6/100 women years after 1 year and a cumulative rate of 1.5/100 woman-years at 5 years. Principal side effects are irregular menstrual bleeding and headaches. No changes in carbohydrate metabolism, blood coagulation, or liver function have been reported. Lipid levels have decreased 5% to 15%. After removal of Norplant, fertility returns rapidly, and there have been no adverse effects on infants. Norplant is currently approved in 12 countries; clinical trials are being conducted in 37 countries.
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PMID:Norplant: subdermal implant system for long-term contraception. 249 46

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

The efficacy and side effects of Norplant contraceptive implants (6 capsules) versus silastic rods were compared in 250 women for 4464 months of use. Both systems were found to be highly effective and well tolerated. There was only 1 pregnancy, and this occurred during the 27th month of use in a woman who had received the Norplant implants. 34 patients (14%) discontinued the study during the 3-year study period because of side effects. Irregular uterine bleeding (either prolonged or too frequent) accounted for 50% of these removals in both groups. Other reasons for removal included mood swings, excessive weight gain, headaches, and ovarian cyst. The total drop-out rate for all reasons was only 20%, indicating that the Norplant method is highly acceptable to US women. Many subjects indicated they were willing to tolerate the bleeding problems associated with Norplant in order to have a convenient longterm method of contraception. 4 of the 8 women who had the implants removed to become pregnancy had achieved this goal by 4 months after removal, indicating that restoration of fertility is not a problem. In general, the 2-rod system has the advantages of easier insertion technique and shorter insertion time, as well as ease of removal, compared to the 6-capsule system.
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PMID:Norplant contraceptive implants: rods versus capsules. 311 87

Three studies directly evaluated the effects of oral contraceptive (OC) use on migraine headache frequency. The Walnut Creek Study in 1980 was unable to demonstrate a higher frequency of migraine headache in OC users discharged from the hospital as compared with nonusers. Another study in 1978 evaluated the effect of 0.5 mg of norgestrel and 50 mcg of ethinyl estradiol (Ovral) on 40 migraine sufferers. 20 patients received this preparation for the first 2 months of the study, the other 20 did not. 29 patients experienced worsening of their headaches with OC use. However, one-third of the patients did note improvement in their headaches. A third study in 1976 of women suffering from migraine suggested that about one-third of women noted worsening of their headaches while taking OCs. The risks of cerebrovascular accident (CVA) include advancing age, smoking, and the use of high-dose pills. Increase in blood pressure, platelet aggregatability, and cholesterol deposition are the three known mechanisms of the risk of stroke. No blind study of the subject has even been made, and a significant minority of OC users reported improvements in their migraine headaches. Circumstantial evidence suggests that there is an increased risk of stroke in OC users, although these case control studies differed with regard to the degree of relative risk. Two of three cohort studies were unable to demonstrate the increased risk of CVA among these women. The absolute risk of thrombotic stroke remains small for OC users, and the absolute risk is probably very small even for those taking OCs. However, the risk of hemorrhagic stroke may increase fivefold in those smoking. For nonsmokers, OC use is probably safer in all age groups than no contraception. A 1977 study showed that 40-44 year old nonsmokers taking OCs had an estimated death rate of 7/100,000. In contrast, those who used no method of contraception had a higher mortality rate of 23/100,000.
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PMID:Relationship of migraine headache and stroke to oral contraceptive use. 354 Feb 97

Triphasil, a low-dose combination oral contraceptive containing levonorgestrel and ethinyl estradiol, was tested in four Planned Parenthood clinics on 317 women between 18 and 34 years of age (mean, 23) for a total of 4,692 cycles, or 361 woman-years of usage. Approximately half these volunteers (165) were nulligravidas, and 309 (97.5%) were white. Despite instructions on proper tablet usage, there were 416 cycles (8.9%) in which one or more tablets were missed. Only one pregnancy occurred, in a cycle in which a total of four tablets was missed, for an uncorrected Pearl index of 0.28 pregnancies per 100 woman-years of usage. No pregnancy resulted from method failure, indicating a 100% efficacy rate for Triphasil when taken properly. The mean length of the menstrual cycle with Triphasil was 27.9 days; the mean length of menses, 4.4 days; and the mean latency period, 2.1 days. Menstrual flow was average in 64.1% of the subjects, light in 34.1%, heavy in 1.3% and variable in 0.5%. Amenorrhea during the tablet-free interval occurred in only 0.6% of the 4,692 cycles in which Triphasil was used. Breakthrough bleeding occurred in 6.9% of first cycles and 3.2% of total cycles; spotting, in 10.7% of first cycles and 4.4% of total cycles. Other symptoms that occurred with an incidence of greater than or equal to 1% were acne (1.0%), appetite increase (1.2%), breast discomfort (2.8%), breast enlargement (1.3%), gastrointestinal symptoms (1.7%), simple headache (1.4%) and nausea (1.1%). A total of 44 women (13.9%) discontinued treatment for medical reasons.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Planned Parenthood experience with triphasil. 365 99


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