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Studies by A. Albert Yuzpe, MD, and Lee H. Schilling, MD, have shown Ovral to be an effective contraceptive after unprotected intercourse at any time in the menstrual cycle, not just in midcycle. As a morning after pill, Ovral is taken in 2 doses: 2 tablets within 72 hours after coitus; 2 tablets 12 hours later, a total of 200 mcg ethinyl estradiol and 2 mg di-norgestrel. Risk of pregnancy from a single act of unprotected midcycle coitus averages 20-30% while the risk from unprotected intercourse at other times in the cycle averages 2-4%. Young, nulliparoous, women would be the prime target for the morning after pill. 98.5% of the women in Yuzpe's study bled within 21 days. The 1.5% who do not bleed within the expected time will either be pregnant or have a delayed period. Ovral can be administered from a pack in the doctor's office. The major complaint about DES was nausea and vomiting. Only 24% of the women taking Ovral reported nausea. The episodes were mild and controlled with an antiemetic. Both doctors and patients are wary of DES because of public concern about teratogenesis. Many doctors recommend termination of pregnancy if it was conceived while the woman was using DES. Ovral use does not usually indicate abortion. The postcoital IUD insertion studies have included small numbers of patients, but the difficulties are that bleeding following insertion may suggest pregnancy, and the potential for pelvic infection is increased. Ovral should not be given to women who have contraindications to oral contraceptives, and benefits and risks should be weighed.
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PMID:Ovral touted as morning-after pill. 1226 90

A study of 2 low-dose oral contraceptives, Loestrin and Nordette, was conducted in association with the National Family Planning Board in Kota Bharu, Kelantan, West Malaysia, to determine differences in continuation rates and reasons for discontinuation. This report includes analysis of 96 women, 91.7% of whom were interval patients, randomly allocated to 1 of the above OCs between December 1979 and January 1981. Follow-up visits were scheduled at 1, 3 and 6 months after admission with symptom grids completed during the 1st, 3rd, and 6th cycles. The continuation rates at 6 months were 85.9 and 89.8 for Loestrin and Nordette, respectively. The corresponding follow-up rates were 73.9 and 68.3. The side effect reported most often among both groups was breakthrough bleeding (BTB). In addition, the proportion of Loestrin users who reported BTB at least once during the study was significantly higher than the proportion of Nordette users (38.3% versus 18.4%, p 0.05). Other symptoms reported were nausea, headaches, intestinal problems, and abdominal pain. No accidental pregancies were reported during this study. There were a total of 6 (11.8%) discontinuations in the Loestrin group and 4 (8.9%) in the Nordette group.
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PMID:A comparative study of Loestrin versus Nordette in Kelantan, West Malaysia. 1226 18

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 effectiveness and side effects of Marvelon (0.150 mg desogestrel and 30 mcg ethinyl estradiol) were evaluated in a multicenter study of 1570 women for a total of 22,158 menstrual cycles. Half the women in the study were under age 25. Only 1 pregnancy was reported, and this was due to patient failure. The frequency of spotting and breakthrough bleeding decreased steadily from 22.3% in the 1st treatment cycle, 14.9% in the 2nd, 8.4% in the 6th, 5.6% in the 12th, to 2.8% in the 21st and then rose slightly from 3.6% in the 24th cycle. This pattern of irregular bleeding during the early cycles is common to all oral contraceptive preparations. Changes in body weight were almost negligible and restricted to women under age 20. There was no change in average blood pressure when compared with pretreatment values. Superficial thrombophlebitis occurred in 7 women. Side effects, including nausea, headache, nervousness, depression, and breast tenderness, declined to negligible levels as treatment progressed. Levels of plasma protein sex-hormone-binding globulin (SHBG) appear to be higher with Marvelon than with a similar preparation containing levonorgestrel and ethinyl estradiol. Other studies have noted significantly higher serum high density lipoprotein (HDL) cholesterol levels with Marvelon than with combined levonorgestrel and ethinyl estradiol. This is attributed to the lack of androgenicity of desogestrel in the clinical dosage used in this study. SHBG and serum HDL levels are increased by estrogens and decreased by androgens.
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PMID:Desogestrel and ethinyloestradiol. 1227 90

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

This article focuses on issues concerning the prescription and restriction of oral contraceptive (OC) use among smokers and new moms based on the findings from Contraceptive Technology's Update 2000 Contraception Survey involving family planning providers and clinicians. Overall, a majority (72%) of the providers restrict the pills to smokers aged 35-39 years, and 88.6% withhold the pills from smokers aged 40 and above. Providers believed that smoking increases the risk for developing cardiovascular disease; thus, all smokers are warned of that risk and are encouraged and advised to stop smoking. In addition, 42.5% of providers recommend new mothers to begin using the pills 4-6 weeks postpartum; and 45.1% say they start nursing mothers on progestin-only pills 4-6 weeks postpartum. Finally, half of survey participants chose Alesse, a 20 mcg pill, as their top choice for women who have experienced nausea on previous OC formulations.
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PMID:Providing combined OCs: examine special issues. 1229 41

Preliminary results of side effects are reported by 66 physicians of the M.F.P.F. (Mouvement Francais de Planning Familial) on 2026 women taking Stediril, 610 taking Aconcept, and 824 taking Ov 28 for at least 6 months (less for dropouts) since 1969. There were no pregnancies or severe complications except 1 case of jaundice and 2 of thrombosed hemorrhoids. Blood pressure was unchanged in 60-70% of cases, and the graph of these changes, except for a slight increase at "up to 10 mm Hg," was a symmetrical bell curve. Stediril and Ov 28 had identical effects on blood pressure, but the curve for Aconcept was flatter. Weight gain of 1 kg or more was reported in 37% of Stediril users and 42% of Ov 28 users (p less than .05). Other side effects showing significant differences between products were: nausea greater with Ov 28, depression greater with Aconcept, metrorragia greater with Stediril, pelvic pain less with Stediril, headaches less with Ov 28, amenorrhea less with Stediril. This absence of serious side effects was considered the most significant French statisitc published to date on oral contraceptives.
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PMID:[Statistical study of side effects in 3460 women taking combined estrogen-progestagens: preliminary results]. 1230 13

A clinical trial was carried out in Kota Bahru to study the acceptability and effectiveness of the 30 mg ethinylestradiol (EE) and 150 mcg levonorgestrel (LNG) oral contraceptive formulation in a new packaging offered as Rigevidon (R). The 30/50 mcg EE/LNG pill is available in the National Family Planning Program in Malaysia since the mid-1970's as Nordetter (R) and Microgynon 30 (R). A total of 87 women entered the study in 1988 and were followed up for a period of 1 year; however, only 83 cases were used in the analysis. 96.4% of the selected women were Malays, 2.4% were Indians, and 1.2% were Chinese. Additional characteristics include a mean age of 28, 74.7% had 6 years of formal education, and an average parity of 2.8 children with 50.6% having 1-2 children and 12% having 5 or more children. During the last 3 months, 47% of the acceptors had used the oral contraceptive pills previously and 41% had not used any contraceptive methods. 81.9% of the acceptors were using the methods for birth spacing. This small study showed that Rigevidon (R) is an effective and safe oral contraceptive. The gross cumulative continuation rate was 89.5 at 3 months, 86.7 at 6 months, 74.8 at 9 months, and 71.3 at 12 months. Reasons for termination include medical reasons (n=12) such as weight increase, dysmenorrhea, nausea, and headache and personal (n=8) reasons. The most frequently reported side effects include nausea, dizziness, and headache; however, there was a decrease in reported complaints by the end of the 8th month. It was observed that the amount of menstrual flow decreased significantly and complaints of dysmenorrhea reduced from 24.1% to 4.2% at 8 months. The acceptability of this method is high and comparable to the other low dose preparations utilized in the National Program; the continuation rate/100 women for Rigevidon was 74.8 after 9 months of use compared to Gestoden's continuation rate of 72.2. This preparation widens the number of low dose formulation (30 mcg estrogen pills) available to our women in their choice for family planning. (author's modified).
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PMID:Study of rigevidon for oral contraception in a family planning clinic in Kota Bahru, Kelantan. 1231 42

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


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