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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

35 predominantly multiparous, sexually active women aged 25-44 years were fitted with levonorgestrel 20 T (Schering) IUDS in the post- menstrual phase, or in rare instances, right after abortion. the devices contained 60 mg of levonorgestrel releasing 20 mcg/day with the life span of 5 years. The patients were followed up every 3-6 months to detect side effects and complications. The first year contained a total of 339 months of observation, while the figure rose to 461 months in the second year. Spotting lasting 15-20 days followed insertion, but in later months only 7% of patients complained of bleeding or menstrual spotting. 7-8% of cases tended to have oligomenorrhea in the first year; 1/3 to 1/2 of them had hypomenorrhea during the first and second year. True amenorrhea started in 20-30% of women, persisting through both years. Longer duration of flow occurred in 32.4-4.57.1% of cases during these 2 years. Hormonal effects (headache, acne, hirsutism, depression, mastalgia, and inflamed varicose veins) ranged from 18.2- 33.3%. Levonorgestrel 20 T demonstrated more superior contraceptive efficacy than Progestasert; however, serious menstrual cycle disorders associated with it also increased. All progestin-releasing devices (the minipill, Norplant, Progestasert) induced menstrual changes, thus their use is preferable for therapeutic indications such as hypermenorrhea and uterine fibroid.
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PMID:[Two-year clinical performance of the Levonorgestrel 20 T IUD]. 1231 72

The Norplant System of levonorgestrel implants and the Depo Provera contraceptive Injection of sterile medroxy progesterone acetate suspension (DMPA) are longterm, progestagen-based contraceptive delivery systems designed to overcome noncompliance which are under review for use in Canada. 150 mg of DMPA, a pregnane compound derived from progesterone, is injected every 3 months. Peak plasma concentrations are reached in 24 hours and plateau for 3-4 months before gradually declining. After termination, ovulation returns on average in 4.5 months, and conception occurs at a median time of 10 months. 90% conceive by 24 months. In the Norplant system, a steady daily supply of 50-80 mcg of levonorgestrel, a gonane progestin derived from the testosterone nucleus which has both progestogenic and androgenic receptor affinity, diffuses from 5 Silastic implants, which must be replaced every 5 years. Ovulation and fertility return rapidly after rod removal. The actual and lowest expected failure rates are equal for both systems. The failure rate for DMPA is .3 pregnancies per 100 women years, while that for levonorgestrel is .4% in 1 year. Although neither method affects blood pressure, DMPA appears to affect carbohydrate metabolism by impairing glucose tolerance and increasing insulin production. Lipid metabolism is also affected. 5% of those who use levonorgestrel discontinue it because of side effects, including headache, mastodynia, and acne; 19.1% of DMPA users did so, especially for weight gain and menstrual cycle abnormalities. Both methods have a higher frequency of menstrual abnormalities than normal. 27.7% of levonorgestrel users experienced prolonged bleeding, while 17% experienced spotting during the first 6 months. However, normal menses usually returned within a year, and only 7.9% discontinued use because of cycle abnormalities. In 1 study, less than 10% of DMPA users experienced normal cycles, and in another study 35% experienced amenorrhea (500/700 discontinued use). Amenorrhea replaced irregular bleeding with continued use, occurring in 68% of users by 2 years. There is also some concern about DMPA and breast cancer and bone loss. Based on 1 case-control study of 110 women with breast cancer who had taken DMPA, the relative risk is highest for those between ages 25 and 34 who use DMPA longer than 6 years. A WHO study concluded that the relative risk of developing breast cancer, because of DMPA, is inversely related to duration of use. A Phase IV study on DMPA and bone mineral density has been undertaken.
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PMID:A comparison of levonorgestrel implants with depo-medroxyprogesterone acetate injections for contraception. 1231 30

Results are presented of a clinical study of Norplant subdermal implants in Colombian adolescents. Implants have been used by 365 adolescents, of whom 174 have completed 2 years of follow-up. Study participants were monitored at months 1, 3, 6, 12, 18, and 24 postinsertion. Among the 174 women, 14% were 14-17 years old and 87% were 17-19. 21% were single, 30% married, and 49% in consensual unions. 38.5% were nulliparous, 56% had 1 child, and 5.7% had 2. 14.3% had a history of abortion. There were no pregnancies in the 2 years. 47.9% of users experienced menstrual irregularities at least once during the 2 years, with 9.3% reporting spotting or staining, 21.2% bleeding, and 19.3% amenorrhea. 6.4% reported nausea, 4.3% headache, 4.3% weight alterations, 2% acne, and 1.4% hair loss. There were 12 removals in the 2 years, 3 each because of menstrual and weight alterations, 2 for headaches, and 4 because of desire for pregnancy. 91.4% declared themselves satisfied with the method. The continuation rate was 93.2% at 2 years. The results suggest that Norplant is a good contraceptive choice for adolescents, but a prolonged study over 5 years is needed to confirm the findings.
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PMID:[Norplant: an effective option for adolescent women. Subdermal implant contraception in adolescent women. Preliminary findings in 174 cases]. 1231 5

The 832 women who accepted Norplant implants at three hospitals in Peru between December 1988 and February 1991 participated in a study of Norplant method acceptability and user characteristics. The women were seen 1, 3, and 6 months after insertion and every 6 months thereafter. They ranged in age from 18 to 40 years and averaged 28. Nearly 78% had completed secondary school or had higher education. The average number of children was 2.1, and 87% had 3 or fewer children. 30.1% of the women had had 1 abortion, 13.0% had had 2, 2.2% had had 3, and 1.1% had had 4 or more. 47.3% of the women had previously used oral contraceptives or IUDs, 13.1% had used rhythm, 11.2% had used condoms or vaginal methods, 4.9% had used injectables, 1.6% had used other methods, and 21.9% had used no method. 47.9% stated they wanted no future pregnancies, 37.4% wanted to wait at least 3 years, and 6.3% were uncertain. Menstrual problems were the major side effect reported. 22 of the 71 removals were motivated by headaches, 18 by menstrual problems and 13 by medical problems. The continuation rate at 12 months was 88.75%. No pregnancies occurred.
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PMID:[Characteristics of Norplant users in Lima, Peru]. 1232 14

The results of the 1998 "Contraceptive Technology Update" Pill Survey indicate that Norplant implants continue to lag on providers list of family planning (FP) choices. 67% of US FP providers who responded to the survey reported no Norplant insertions in the year preceding the survey. For the 18.1% who inserted 1 to 5 implants, 11.7% removed the same number. The number of removals outranked insertions in the 3 subsequent insertion ranges. Headaches, irregular bleeding, and the end of the 5-year use period were among the major causes of method termination. Research on Norplant has indicated that method continuation is substantially enhanced when the acceptor is a mature woman with a long-term interest in contraception, has been counseled about potential side effects, and is able to accept these side effects. Partner attitudes toward Norplant are another important determinant of satisfaction.
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PMID:Norplant: overcoming barriers to method use. 1232 44

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

This article summarizes current knowledge on the mechanism of action, side effects, and effectiveness of Norplant contraceptive implants. The most common side effect of the implant method is its disruption of the menstrual cycle, especially in the 1st few months of use. Long intervals without frank bleeding may occur and be misinterpreted as pregnancy in women who have not been counseled about this possibility. The average annual continuation rate was 84/100 in a study of 324 women from several countries who were followed for 5 years after Norplant implantation. The net cumulative pregnancy rate for the 5-year study period was 0.6/100. Reasons for method termination included menstrual problems, other medical problems (headache, depression, fatique), planning pregnancy, and other personal reasons (change in marital status, change in residence). To provide training for doctors, nurses, and counselors, the Population Council has established a network of 5 training institutions. Within the next few years, drug regulatory agencies are expected to approve use of Norplant implants in many countries. Although at present the method is available only in Finland and Sweden, Thailand and Indonesia are considering the method and clinical trials are underway in India, China, Brazil, and the US. A consulting committee of the World Health Organization has concluded that Norplant implants are a suitable contraceptive method for use in family planning programs.
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PMID:Norplant contraceptive implants: a new contraceptive for women. 1234 Apr 73

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


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