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Fertility control by cyclic norethindrone (Norlutin), 17 alpha-ethinyl 19-nortestosterone, plus .06 mg 3-methoxy ethinyl estradiol (Ortho-Novum) was studied in 364 women over a period of 32 months for a total of 6062 cycles. No patient who followed the instructions became pregnant. 37 patients stopped the medication for various reasons. The interval between stopping medication and becoming pregnant averaged 1.6 months. 13 of these pregnancies occurred after 11-15 cycles of treatment. Children born to these mothers were normal with no virilization observed. Findings from all Papanicolaou smears and cervical biopsies were normal. The desirable effects of diminishing the menstrual flow, reducing dysmenorrhea and regulating the menstrual cycle, plus the all-important one of contraception, far outweighed minimal and infrequent undesirable side effects (in order of frequence: chloasma, hot flashes, headache, nausea, acne, abdominal pain, dizziness and urticaria). In only 4.8% of the total 6062 cycles was some complaint made.
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PMID:Long-term administration of norethindrone in fertility control. 1227 4

Results of a large multicentered clinical trial of a new contraceptive vaginal ring show that the new ring may be about as effective as oral contraceptives but with fewer side effects. The ring, which is a little smaller than a 75 mm diaphragm and has a Silastic inner core and outer tubing, is avilable in 2 sizes (50 mm or 58 mm) and contains a middle layer with a steroid mixture of estrogen and progestin. Both types of ring contain about 100 mg levonorgestrel and 50 mg estradiol. Ovulation is suppressed by the steroids in the ring. The ring is placed in the vagina for about 3 weeks and then removed for 1 week. Withdrawal bleeding occurs when the ring is removed. Comparative studies of the effectiveness of the ring and a pill (Nordette, which contains 150 mcg levonorgestrel and 30 mcg estradiol) show that after a year's use, both type of contraceptives had a pregnancy rate of about 3 pregnancies per 100 users. Ring users had higher continuation rates than pill users (50/100 women for the ring vs. 30/100 for the pill). Reasons for discontinuation for the ring include occurrence of vaginal discharge, vaginitis, and menstrual problems. Ring users had lesser incidence of nausea and headache compared to pill users; they also did not experience an increase in angiotensinogen levels or blood pressure. Another advantage of the ring is its once-a-month administration. Investigators are still testing the best method for using the ring. However, as testing is not yet complete, application for approval by the Food and Drug Administration may take quite some time.
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PMID:Trials point to effectiveness of new vaginal ring. 1227 58

The 3 triphasic oral contraceptives currently marketed in the US are describes in reference to steroid composition and manufacturers claims concerning the reduced side affects associated with the triphasics. These triphasics are 1)Ortho-Novum 7-7-7, producted by the Ortho Pharmaceutical Corporation; 2) Tri-Norinyl, produces by Syntex; and 3)Triphasil, produced by Wyeth Laboratries. The 1st 2 formulations were approved by the Food and Drug Administration (fda) in early 1984, andd Triphasil was approved in December, 1984. Despite the recency of triphasic availability, a survey of 13 family planning clinicians, conducted by Contraceptive Technology Update, revealrd that triphasics were the 2nd most common type of OC prescribed by the clinicians. All 3 triphasics provide varying daily doses of progestogen throughout the cycle but only Triphasil varies the daily dose of estrogen. Triphasil provides a total progestogen dose of 1.925 mg of levonor estrel for the entire cycle, and a daily dose of 0.05 mg for 6 days, 0.075 mg for 5 days, and 0.125 mg for 10 days. The total dose of ethinyl estradiol provides by Triphasil is 700 mcg, and the daily dose is 30 mcg for 6 days, 40 mcg for 5 days, and mcg for 10 days. Tri-Norinyl provides a total progedtogen dose of 15.0 mg ofnorethindine at a daily dose of 0.5 mg for 7 days, 1.0 mg for & days, anf 0.5 mg for 5 days. The total ethinyl estradiol dose is 735 mcg provided at a constant rate of 35 mcg for 21 days. Ortho-Novum 7-7-7 provides a total progestogen dose of 15.75 mg of norethindrone at a rate of 0.5 mg for 7 days, 0.75 mg for 7 days, and 1.0 mg for 7 days. The total dose of ethinyl estradiol is 735 mcg provided at a constant rate of 35 mcg/day for 21 days. The triphasics provide low steriod dosages in order to minimize longterm adverse effects; however, unlike other low dose formulations, the triphasics, according to the manufacturers, are associated with only minimal breakthrough bleeding problems. Ortho claims women who use Otrho-Novum 7-7-7 have bleeding patterns similar to those associated with Ortho-Novum 1-35 by the end of the 3rd menstrual cycle. Syntex claims that the incidence of breakthrough bleeding, amenorrhea, weight gain, headachess, nausea, and edema among women who use Tri-Norinyl is similar to that observed among women who use Norinyl 1-35. Wyeth reported that among women who took Triphasil for 25 montha, the total incidence of breakthrough bleeding was only 5.7%. The cost of the triphasics is similar to the cost of other low dose OCs, and the reiphasics are reportedly as effective as the higher dose OCs.
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PMID:Three triphasic oral contraceptives now available in U.S. 1227 12

The acceptability and effectiveness of a progestogen-only oral contraceptive (OC), Ovrette, during lactation were investigated in 200 women recruited from a teaching hospital in Khartoum, Sudan. Ovrette contained 0.075 mg of norgestrel. 69 women (34.5%) had used OCs at some point prior to the index pregnancy. Serious complications (e.g., severe headache, chest pain, leg pain, abdominal pain, blurred vision) were reported by 8 respondents during the 12-month study period. Less serious side effects included dysmenorrhea (49 women), nausea (28 women), dizziness (38 women), vaginal discharge (86 women), headaches (78 women), and breast discomfort (21 women). Overall, 143 women (71.5%) experienced at least 1 side effect. Of the 21 women (10.5%) who discontinued Ovrette use before 12 months, 9 were motivated by menstrual problems and other side effects. The 12-month continuation rate was 89.1%. There were 2 pregnancies, only 1 of which represented method failure. These findings are consistent with previous studies indicating that use of progestin contraceptive agents is associated with more menstrual disturbances and pregnancies than combined OCs. Use of combined OCs is contraindicated during lactation, however.
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PMID:A study of a progestogen only oral contraceptive for lactating women in Khartoum, Sudan. 1229 69

Women who do not have contraindications for oral contraceptives (OCs) and have experienced failure of their contraceptive method or used no contraceptive at all an use emergency postcoital contraceptive pills (ECPs). In fact, if used correctly, they could prevent 1.7 million unplanned pregnancies each year which is 50% lower than such pregnancies which already occur each year. They could also reduce the number of annual induced abortions by 50% from (1.6 million to 800,000). Various postcoital treatments in the US are 2 pills of Ovral within 72 hours of intercourse then 2 more pills 12 hours later and 4 pills of either Lo/Ovral, Nordette, Levlen, Triphasil, or Tri-Levlen followed by 4 more pills 12 hours later. Some gynecologists contend that any low-dose combined OC could be used as an ECP, but not study proves this. Besides, providers who do so risk a malpractice suit, because postcoital contraception is not on OC labels. An attorney suggests using OCs only for an emergency and to document all attempts at informed consent. Many children and clinicians have limited or no knowledge about ECPs. Those health providers who are familiar with them tend not to prescribe them because they fear legal actions. ECP side effects include severe nausea or vomiting, headache, breast tenderness,, dizziness, and fluid retention. These effects are not as great as the health risks of unplanned pregnancies, however. Yet, they are unpleasant enough to discourage repeated ECP use. Use of different methods of determining the number of pregnancies has resulted in broad ECP effectiveness rates (0-96% and 56-94%). Another analysis using combined data from the studies yielding the various results shows the effectiveness rate to be 75%. Anti-abortion groups may object to ECP use, just as they do for RU-486 which has fewer side effects, because one of its mechanisms of preventing pregnancy is it prevents implantation.
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PMID:Postcoital pills could cut unplanned pregnancies by half. 1231 83

This paper outlines methods of therapy utilizing newer combinations of estrogens and progestins. The specific agent and length of treatment depends on the extent of disease, severity of symptoms, presence of infertility and response to pseudopregnancy. Structural formulas for 19 synthetic preparations are shown. Of 36 patients with proven endometriosis in which pseudopregnancy was induced by the use of these newer agents, satisfactory objective in 82%. Pregnancy occurred later in 6 of 10 patients who had previously been infertile and wished to become pregnant. The optimum maintenance dose is 4-6 mg of chlormadinone acetate or ethnodiol diacetate with .2 mg of mestranol and 5-10 mg of megestrol acetate with .2 mg of ethniyl estradiol. Dosage is increased only when break through bleeding occurs. Gain in weight occurred in almost 1/2 of the patients. The decidual reaction was just as great as that produced formerly by large doses of Enovid. In a more recent study 60 patients were treated with Norlestrin, 20 with Lyndiol and 20 with Ovral. Satisfactory objective and subjective remissions were obtained in 89%. Pregnancy has occurred subsequently in 17 to 43 patients who desired pregnancy. All infants have been normal. The optimum maintenance doses seem to be 10-15 mg if Norlestrin, 2.5-5 mg Lyndiol or .5-1 mg of Ovral. The most common side effect was weight gain in 35%. These agents may be used prior to conservative surgery in order to soften areas of fibrotic endometriosis or to pinpoint areas otherwise overlooked. The length of preoperative treatment depends on the extent of disease, 6 weeks being usual. The indication for prolonged pseudopregnancy is recurrent endometriosis following surgery, also proven vaginal endometriosis. Subsequent to conservative surgery, 12 to 24 weeks of therapy are given in order to inhibit ovulation and prevent reactivation of any remaining areas of endometriosis. Tables show commercial combinations and dosage regimens. Nausea, break through bleeding, breast soreness, acne, water retention, isoninia, irritability, lethargy, headaches or development of leiomyomas are side effects to be dealt with by modifying the treatment. Thromboembolic disease has not been a complication in over 500 patients but should be looked for as it has been reported by others. The effect of long-term use of these drugs has been shown to be entirely reversible without subsequent deleterious effects. Severe hepatic disease or previous mammary carcinoma are contraindications. Excessive side effects may necessitate other treatment but the newer drugs reduce this chance. The diagnosis of endometriosis should first be proven.
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PMID:Newer synthetic progestins for the treatment of endometriosis. 1233 29

Oral contraceptive (OCs) users continue to complain of side effects such as headaches, mood swings, and weight gain, and switch pill formulations. Questionnaires for an annual oral contraceptive survey were mailed to subscribers in the May 1992 issue of Contraceptive Technology Update (CTU) 137 of 1600 surveys mailed were returned for a response rate of 8.5%. 64% of the respondents were nurse practitioners, 19% were physicians, 7% were physician assistants, 5% were registered nurses, and 5% were other types of providers. OC users tend to blame headaches, mood swings, or gaining weight on the pills. The CTU survey found that more than 60% of health care providers would advocate switching to a lower-dose estrogen pill or to a progestin-only pill for headaches and mood swings. For weight gain their first choice of treatment would be counseling about life style changes. 50-60% of American women discontinue OCs in the first year, mainly because of side effects such as breakthrough bleeding, headaches, nausea, weight gain, and acne. 89% of respondents said few women had sever, recurring headaches, but should that occur 66% of respondents would change to a lower-dose estrogen pill. Only 9% of respondents would recommend relaxation exercises and analgesics. 67% of respondents would change the pill formulation before suggesting a life style change when patients complain about mood swings. Ortho Novum 7/7/7 was the pill of choice for 61% of survey respondents, and Triphasil was the 2nd choice by 43%. An international group of physicians recommended that manufacturers, physicians, and OC providers take the lead in providing patients with acceptable counseling concerning correct OC use.
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PMID:Experts debate pill switching to combat noncompliance. Special report: annual pill survey. 1234 22

This article answers some questions about use of emergency contraceptive pills (ECP) in the US. It is acceptable to prescribe ECPs over the telephone. ECPs should not be given to women with severe migraine headaches with neurologic impairment. ECPs are acceptable for women who are smokers and over 35 years old, diabetics with vascular disease, women with a history of severe migraine, and women with a benign or malignant liver tumor. Women who seek ECPs over 72 hours after unprotected sexual intercourse could have ECPs, insertion of a Copper T380 IUD, or Ru-486, when available in the US. Lo-Ovral4+4 is the preferred ECP. Ovral2+2 is less often available and tends to cost more. An ECP prescription might indicate Phenergan (25 mg), 4 tablets, taken between 6 and 7 PM, and repeated in 12 hours. Another ECP prescription might indicate Lo-Ovral (21-pill pack), 4 tablets taken one half hour after anti-nausea medication, and repeated in 12 hours. If nausea is severe from the first or second dose of Lo-Ovral, an extra tablet of Phenergan may be taken. For continued contraception, the patient should be prescribed a low-dose pill and not a 50 mcg pill. The most common transition from ECP combined pills to regular oral contraception is to prescribe 4 tablets followed by 4 tablets 12 hours later, and to start a new package of pills the Sunday after menstruation begins. Nonlapsed pill taking involves taking the 4 tablets, followed by 4 tablets in 12 hours, and 1 tablet taken daily for the next 13 days (with backup contraception the first 7 days), and a lapse for 7 days. Nothing needs to be done for vomiting. Women are not likely to abuse this option. It should be widely known and appreciated that mistakes do happen, emergency contraception does work, and women should be aware of ECPs. 98% of women bleed by 21 days after ECP use. There appears to be no increased risk of birth defects among pill users who become pregnant.
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PMID:10 common questions on emergency contraception. 1234 14

Norethindrone 2 mg. with mestranol 0.1 mg. (Ortho-Novum 2 mg.) was taken in cyclic fashion for fertility control by 62 private patients through 312 cycles. Each patient was interviewed every month during the trial period. No pregnancies occurred. The most common side effects noted were breakthrough bleeding, headache, fatigue and tension, nausea and depression. Five patients left the study because of depression and one because of nausea. It is suggested that the use of norethindrone 2 mg. with mestranol 0.1 mg. be reserved for the following situations: (1) those patients who have used other methods without success and in whom a further pregnancy would, in the opinion of the family physician, create hardship; (2) those patients in whom fear of pregnancy is part of the cause of marital problems; and (3) those patients in whom the product is primarily used for the treatment of menstrual disorders.
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PMID:The use of norethindrone (2 Mg.) with mestranol (0.1 Mg.) in fertility control; a preliminary report. 1399 1

The usefulness of a new oral contraceptive compound containing norethindrone 5 mg. and mestranol 0.075 mg. (Ortho-Novum) was studied. One hundred and seventeen private patients used this preparation for a total of 998 menstrual cycles. There were no pregnancies. Side effects were minimal and caused few (11 patients) to discontinue use. The most significant of these was weight gain and a premenstrual tension syndrome including nausea, breakthrough bleeding and skin effects. Other symptoms were minor and easily controlled. Instruction in use of the preparation is easy. Patient acceptance is excellent. Possible masculinizing effects, liver damage, or harmful effects on the uterus were checked specifically by laboratory evaluation; no significant abnormal findings were noted.This appears to be an effective oral contraceptive which is well accepted by the patient and which produced no serious side effects as used in this study.
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PMID:A new and practical oral contraceptive agent: norethindrone with mestranol. 1402 23


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