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71 Egyptian women using Norplant contraceptive implants for 1 year were followed with laboratory testing of carbohydrate, lipid and protein metabolism, liver and kidney function tests, serum iron and iron binding capacity and pituitary response to GnRH. The subjects were normal, healthy fertile, non-pregnant, non-lactating women who had not used hormone for 6 months. There were no pregnancies. Most women complained of altered menstrual patterns. Some reported headache, dizziness, increased vaginal discharge, nausea, and pain at the insertion site. There was no significant change in fasting or post-prandial glucose, or kidney function. Cholesterol decreased significantly at 3 months, triglycerides fell at 3 and 12 months, and HDL rose significantly at 3 and 12 months. SGPT fell significantly at 3 and 12 months. Total protein and albumin was significantly lower at 12 months. Serum iron and total iron binding capacity were significantly elevated at 3 and 12 months. Secretion of LH and FSH fluctuated around normal limits. The lipoprotein findings are discrepant from those reported from other developing countries in Norplant trials.
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PMID:Clinical chemistry and pituitary response changes in Egyptian acceptors of L. Norgestrel six rods implants during the first year of use. 1228 53

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

A clinical trial was carried out on the levonorgestrel-containing subdermal contraceptive implant to evaluate its efficacy and acceptability among Malaysian women. The study recruited 121 women in and around the Kuala Lumpur Federal Territory over a 13-month period (March 1986-March 19870 and followed regularly for 2 years at intervals of 3, 6, 12, and 24 months. The acceptors consisted of 53.7% Malays, 24.8% Indians, and 21.5% Chinese. 81% of the selected females were between 20-34 years in age (mean=30). The average parity was 3.9 children; 81.8% reported that they did not want to have a child in the he next 3 years. In the last 6 months, 45.5% of the study group had used the oral contraceptive pills, 15.7% had used the intrauterine contraceptive device, and 17.4% had not employed any method. The results showed that the subdermal implant Norplant (R) is effective and safe. The gross cumulative continuation rate was 93.8 at 6 months, 88.2 at 12 months, and 72.2 at 24 months. Within the 24 month period, 26 terminations occurred as a result of pregnancy (n=1), menstrual problems (n=9), medical reasons (n=12), and personal reasons (n=4). the gross cumulative termination rate/100 women for pregnancy was 0 at 12 months and 1.7 at 24 months. Major side effects include menstrual problems, weight gain, dizziness, and headache. After 1 year, 13.3% of the cases (n=2) had the implant removed. The acceptability of the method among our women in 4 clinics around Kuala Lumpur and other Norplant (R) studies in other countries is comparable to the intrauterine devices among Malaysian women; the termination rate for accidental pregnancy is lower than that of IUD. The device is easy to administer in a small clinical set-up though it requires personnel specially trained in the surgical techniques; 86.0% of the acceptors reported complication-free insertion. This may be a method to be introduced to our National Family Planning Program in our efforts to offer a wider range of safe and effective methods of family planning. (author's modified).
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PMID:A study of the acceptability and effectiveness of Norplant (R) contraceptive implants in Kuala Lumpur, Malaysia. 1231 41

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

In the period 1989-1994, Honduran women participating in the Project Health Sector 2 have been exposed to a contraceptive mini-pill, Ovrette. The Institute of Honduran Social Security (IHSS) approved the program (in which Ovrette distribution is included) in May 1990. The program is partly funded by the Population Council, which is funded by USAID Registry with the Department of Health was not required under the Health Code since Ovrette had entered the country as a donation. In June 1993, a Commission of the Honduran Medical Association reported that the women were not given any written information on the drug. Ovrette is an oral contraceptive manufactured by Wyeth. Its active ingredient is a progestagen, Norgestrel. Contraindications for Ovrette include: non-lactating women who exhibit side-effects such as dizziness, water retention, migraine, etc.; non-lactating women with contraindications for estrogen; lactating women who reject other contraceptive drugs. The US Pharmacopeia and the US Food and Drug Administration do not authorize the drug for use by lactating women. As with other progestagens, Norgestrel passes through to the mother's milk. In 1993, the US Pharmacopeia reported that these hormones can cause harmful effects to the child, and recommended switching medications or discontinuation of lactation. In 1983, the WHO expressed concern about the possibility of injury caused by the progestagens. The possibilities included alterations to personality, behavior, anatomy of sexual organs, reproductive capacity, immunological function and development of neoplasia. Possible damages in puberty or during the reproductive age are not known since there is no study of exposed children that are older than 12 years of age.
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PMID:Honduran women received no written information on contraceptive pill. 1231 16

"New Era for Injectables," a report published in the most recent issue of the Johns Hopkins University School of Hygiene and Public Health's Population Reports, notes that injectable contraceptives are among the most effective family planning methods. Most clinical trials report less than one pregnancy per 100 women during the first year of use, making injectables as effective as Norplant implants, the best copper IUDs, and voluntary sterilization. Injectables also protect women against ectopic pregnancy, help to prevent endometrial and possibly ovarian cancer, and may help women with anemia and sickle-cell disease. The major side effect of injectable use is changes in menstrual bleeding. Some women also experience weight gain, and a few report headaches, dizziness, abdominal discomfort, acne, and moodiness. The most widely-used injectable is the progestin-only DMPA (depot medroxyprogesterone acetate), known under the brand name Depo-Provera and manufactured by the Upjohn Company. Women receive an injection every 3 months. Another progestin-only injectable, NET EN (norethindrone enanthate), is taken every 2 months. Cyclofem and Mesigyna, two new monthly injectables which combine estrogen and progestin, are currently being introduced in a number of countries. Worldwide, 1.5% of all married women of reproductive age who use some form of family planning use injectables. The highest level of use among such women is in Indonesia and Thailand where 15% and 12%, respectively, use injectables. Donor agencies have been responding to increasing numbers of orders for injectables from family planning programs in developing countries, while the UN Population Fund, the largest supplier, shipped 12 million doses of injectables in 1992 and 20 million in 1994. The 1992 US Food and Drug Administration approval of DMPA has made it possible for the US Agency of International Development to respond to requests for it.
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PMID:Millions of couples to have choice of injectable contraceptive. 1234 10

Levonorgestrel-releasing implants are long acting contraceptives, approved for 5 years of continuous use. Two marketed systems, the six capsule Norplant use of tradenames is for product identification purposes only and does not imply endorsement. and the two rod Jadelle, have essentially equal rates of drug release, pregnancy and adverse events over 5 years of use. Randomised clinical trials and controlled cohort observations indicate that for the first 3 years, when pregnancy rates are at or almost zero, no other contraceptive system is more effective, although etonogestrel implants provide equal effectiveness. Annual pregnancy rates rise in the fifth year of continuous use but remain below 1 per 100 women. Annual pregnancy rates of Norplant users remain below 1 per 100 throughout 7 years of continuous use. Levonorgestrel implants provide low progestogen doses; 40-50 microg/day at 1 year of use, decreasing to 25-30 microg/day in the fifth year. Serum levels of levonorgestrel at 5 years are 60-65% of those levels measured at 1 month of use. Adverse effects with levonorgestrel implants are similar to those observed with progestogen only and combined oral contraceptives. Risks of ectopic pregnancy, other pregnancy complications and pelvic inflammatory disease are reduced in comparison with those of women using copper or non-medicated intrauterine devices. Risks of developing gallbladder disease and hypertension or borderline hypertension, although small, are about 1.5 and 1.8 times greater, respectively, in women using levonorgestrel implants than in women not using hormonal contraception. Other serious diseases have not been found to occur significantly more frequently in levonorgestrel implant users than in women not using hormonal contraception. The great majority of levonorgestrel implant users experience menstrual problems, but serious bleeding problems are not more frequent than in controls. Other health problems reported more frequently by levonogestrel implant users than by women not using hormonal contraception in a study of 16000 women included skin conditions, headache, upper limb neuropathies, dizziness, nervousness, malaise, minor visual disturbances, respiratory conditions, arthropathies, weight change, anxiety and non-clinical depression. Clinical depression is not more frequent in women using implants compared with those not using hormonal contraception (i.e. using intrauterine devices, sterilisation). Removal problems occur less frequently with Jadelle than with Norplant. The mean removal time for Jadelle is half that of Norplant. Levonorgestrel implants in nationally representative scientific samples, in randomised trials, and in controlled cohort studies have continuation rates as high as or higher than any other reversible contraceptive over a duration of 5 years. This would imply that the satisfaction women derive from the contraceptive effectiveness of levonorgestrel implants greatly outweighs the dissatisfaction that may accompany menstrual disturbances and other adverse effects associated with implants.
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PMID:Risks and benefits, advantages and disadvantages of levonorgestrel-releasing contraceptive implants. 1265 Jun 33


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