Gene/Protein Disease Symptom Drug Enzyme Compound
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Researchers analyzed 1991 data on 678 12-45 year old women attending either a university-based family planning clinic, 8 Planned Parenthood clinics, or the private practice or health maintenance organization clinic of 8 physicians in southeast Texas to determine the characteristics of these women who accepted Norplant shortly after its approval in the US and their overall attitude towards Norplant. Most acceptors were 25 years old (64.1%) and not married (67.4%). In fact, 45% were 21 years old which was higher than expected. Norplant was 1 of the first contraceptives used by 44% of the women. Further, these women had only recently chosen to prevent unplanned pregnancy. The mean family size was 1.2. 35 of the women did not want any more children. The remaining 67% used Norplant to space births. 32.5% of the women had experienced at least 1 abortion, which was significantly higher than the national adjusted rate. The leading reasons for choosing Norplant included dissatisfaction with previous methods (55.5%), its convenience (38.7%), and confidence in its effectiveness (20.8%). 44% of the women were not concerned about Norplant. The main concerns of the other women were pain during insertion (21.9%), menstrual changes (17.9%), and hormonal effects (16.2%). Further, 11.8% were worried about Norplant's effect on future pregnancies. Most women (61.1%) had previously used oral contraceptives (OCs). 5.3% had used no method in the last 3 months. 42.2% had used condoms either alone or with a spermicide. Yet, 48% of them would now either stop using them or use them sometimes. They constituted 40% of the unmarried women. This resulted in an increased risk of acquiring a sexually transmitted disease or HIV among 25% of the sample. Medicaid patients paid nothing for Norplant or its insertion. Patients who received Norplant via the physician training program paid nothing for Norplant but did for its insertion. Some clinic patients made required copayments of $9-$100. Private practice patients paid $500-$750 for Norplant and its insertion.
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PMID:Characteristics and attitudes of early contraceptive implant acceptors in Texas. 142 82

A randomized comparative study of levonorgestrel-releasing intrauterine device (LNG-IUD) and Norplant-2 implants was carried out in 200 women for 36 months. Three thousand one hundred woman-months of use were observed with each device. Only one pregnancy occurred in users of LNG-IUD at the 12th month of use. The change in bleeding pattern was the most frequent reason for discontinuation. The discontinuation rate for irregular bleeding with Norplant-2 was 17.3 and 26.8 at 24 and 36 months, respectively, as compared to 3.3 with LNG-IUD at both 24 and 36 months. The differences were statistically significant. Removal for amenorrhea and pain only occurred in acceptors of LNG-IUD. About 20-40% of women using Norplant-2 had prolonged bleeding through 36 months. The percentage of amenorrhea in LNG-IUD was the highest (29.3%) at the end of two years of use. More than 97% of subjects reported satisfaction with the methods used by themselves.
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PMID:Three years' experience with levonorgestrel-releasing intrauterine device and Norplant-2 implants: a randomized comparative study. 151 93

The Norplant System consists of 6 capsules each containing 36 mg of crystal line levonorgestrel (LNG), for a total dose of 216 mg LNG. The capsules are inserted subdermally in the mid-upper arm, and LNG diffuses continuously through the capsule walls for 5 years. In the United States the Norplant System was approved in December 1990. The initial rate of hormone delivery is about 85 mcg/day, then decreases over the next 9 months to 5 mcg/day, and over the ensuing 9 months to 35 mcg/day. Thereafter, the diffusion rate levels off for the next 3.5 years, averaging around 30-35 mcg/day. Removal results in a drop in the plasma concentration of levonorgestrel to below contraceptive levels within 24 hours and below the detectable limit of .1 pg/ml at 96 hours. Preliminarily data from 402 users over 5 years show improvements of Norplant produced better efficacy in all weight classes and a lowered cumulative rate of 1.1 pregnancies of 100 users. The pregnancy rate for the first year of use is 02., better than for oral contraceptives. Side effects include headache, nervousness, nausea, dizziness, dermatitis, acne, change of appetite, breast tenderness, minimal weight gain, some change in hair distribution, and adnexal enlargement. Adverse reactions include breast discharge, possible cervicitis, musculoskeletal pain, abdominal discomfort, leukorrhea, and vaginitis. More than the usual number of bleeding days occurred in slightly more than one fourth of the patients, prolonged bleeding in 27.6% spotting in 17.1% and amenorrhea in 9.4% of patients. Hyperlipidemic users should be observed for possible low-density lipoprotein elevations. The cumulative discontinuation rate for pregnancy was 3.9 per 100 users; for bleeding irregularities the rate was 25.1 per 100 users, and for other medical results it was about 22.4 per 100 users. Personal reasons for discontinuation accounted for 38.7 per 100 users, equivalent to a cumulative continuation rate of about 30 per 100 users over the 5-year duration.
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PMID:The NORPLANT system of contraception. 168 4

This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

The mean of the Norplant usage period of 338 acceptors was 44.4 months. Most users had poor education and low incomes; the lower their socioeconomic status, the longer they used the Norplant implant. Return to fertility 3 months after removal was 38.46%; after 6 months, 71.43%; after 9 months, 74.46%; and after 12 months, 75%. The continuation rate at year one was 82.84%; year 2, 74.85%; year 3, 68.34%; year 4, 64.79%; while year 5 was 8.58%. The mean removal time was 21 minutes. There was a very significant difference between trained and untrained removers in the duration of removal. The average number of capsules removed was 5.64. There was no significant difference between trained and untrained removers in successful capsule removal. Reasons for removal were expired date and non-medical complaints such as changing to other contraceptives and the wish to become pregnant; medical complaints were dizziness, vertigo, spotting and amenorrhea. Removal was prompted by acne, metrorrhagia, two or more medical complaints, menorrhagia, physical pain, tenderness at insertion site and spotting. There were no pregnancies found among acceptors. However, 5.92% of the acceptors were pregnant at the time of insertion because of misdiagnosis. It can be concluded that Norplant is effective, safe and acceptable but removal needs trained persons.
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PMID:The Norplant removal training and service at Dr Kariadi Hospital, Semarang, Indonesia. 177 63

Contraceptive research and development is currently addressing the preservation of female fertility through birth control, the promotion of birth control as an essential component of a healthy life-style, and prevention of the spread of sexually transmitted diseases. The combined oral contraceptive (OC) remains the most popular birth control method, and the introduction of new progestogens has lowered the incidence of cycle control problems and improved metabolic data. As protection against human immunodeficiency virus (HIV) transmission becomes a central concern among contraceptive users, the condom has increased in popularity. Recent innovations in the field of barrier methods include the female condom and cervical cap; plastic is being tested as a component of male condoms. Advances in IUD technology include Cu-safe 300 (a slim device with an anti-expulsion design), the flexigard (a frameless device associated with reduced pain and bleeding), and levonorgestrel-releasing devices. Among new contraceptive delivery systems are the vaginal ring, Norplant, and monthly combined injectables. Bioself 110, an electronic fertility indicator, refines the practice of natural family planning. For postpartum contraception, researchers are working on a delivery system for natural progesterone, and lactational amenorrhea has gained recognition as an effective method of pregnancy prevention.
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PMID:New thinking in contraception. 184 13

This is a review of the impact of spinal cord injury on female sexuality, which has received far less attention than male sexuality, and on menstruation, contraception and pregnancy, which have been reported more extensively. The few reports of sexuality in women after spinal cord injury suggests a wide range of adaptability, from 40% to 88% of the subjects achieving satisfactory sexual activity. Some women were able to adapt a positive body image and find new ways of stimulation to orgasm, despite altered body shape, bladder and bowel incontinence, spasticity, and lack of sensation often resulting from spinal injury. The pill, vaginal methods, and IUDs are not recommended, but condoms and possibly Norplant, are appropriate for these women. Menstruation, often ceasing for several months after injury, usually resumes. One study reported lack of menstrual pain, others did not. Many spinal injuries women have achieved 1 or more pregnancies. A few cases have been described of successful pregnancy when the injury occurred during gestation, as has 1 intrauterine death that was successfully delivered by induction. Premature cervical dilatation and labor and small-for-dates infants are more common than usual, but spontaneous abortion are not. Some of the typical problems in pregnancy are urinary tract infections, decubiti, anemia, pedal edema, weight transfer problems, thrombophlebitis, TIA episodes, and nausea. A more serious problem is management of labor, especially if the woman cannot perceive labor pains, or cannot bear down. Frequent check-ups and early hospitalization are recommended. A potentially fatal risk in those injured at T6 or above, is autonomic dysreflexia, stimulated by induction, labor, delivery, or even breast feeding. Autonomic dysreflexia can be treated with epidural anesthesia with lidocaine. Induction is contraindicated. Lactation may cease after 3 months or so because of lack of nipple stimulation.
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PMID:The impact of spinal cord injury on female sexuality, menstruation and pregnancy: a review of the literature. 188 48

The International Planned Parenthood Federation (IPPF) new statement on the diagnosis of pregnancy was drawn up in April 1990. A pregnancy diagnosis includes clinical evaluation of the woman's history, symptoms, physical examination, and pregnancy tests. Pregnancy symptoms may include amenorrhea, nausea, vomiting, enlargement and tenderness of the breasts, frequent urination, and changes in appetite and food and drink habits. If biochemical testing is not possible, a reliable clinical diagnosis of pregnancy cannot take place before 6-8 weeks. At this time, the clinician can observe cervical softening and uterine softening and enlargement if a woman is pregnant. If the uterine size does not match the length of amenorrhea, clinicians should suspect the following: earlier or later conception than indicated, ectopic pregnancy, incomplete or missed spontaneous abortion, twin gestation, hydatidiform mole, or other uterine anomaly. They should suspect ectopic pregnancy in women with smaller than expected uterine size when they have been sterilized or are using an IUD or are using low-dose progestogen-only pills or Norplant. They should refer women with smaller than expected uterine size who are experiencing bleeding and/or pain to a more sophisticated clinical facility, where an accurate diagnosis of and adequate treatment for ectopic pregnancy can be done. Biochemical pregnancy tests consist of antibodies that mark human chorionic gonadotropin (hCG) from a urine or serum sample. hCG levels increase beginning about 10 days after fertilization. The most convenient and inexpensive pregnancy test for clinics is the immunoassay test (slide test), which requires a urine or serum sample. It can provide reliable results a few days after the missed menstrual period. Clinicians should provide appropriate counseling regardless of whether the client wishes to continue or terminate the pregnancy.
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PMID:New IPPF statement on the diagnosis of pregnancy. 192 37

A controlled release system utilizes a polymer matrix or pump as a rate-controlling device to deliver the drug in a fixed, predetermined pattern for a desired time period. These systems have the following advantages compared to other methods of administration: 1) plasma drug levels are continuously maintained in a therapeutically desirable range, 2) harmful side effects from systemic administration can be reduced or eliminated by local administration from a controlled release system, 3) drug administration may be improved and facilitated in underpriviledged areas where good medical supervision is not available, 4) administration of drugs that have short in vivo half lives may be greatly facilitated, 5) continuous small amounts of drug may be less painful than several large doses, 6) patient compliance may be improved, and 7) this method is relatively less expensive and less wasteful of the drug. Disadvantages include possible toxicity, need for surgery to implant the system, possible pain, and difficulty in shutting off release if necessary. Two types of diffusion-controlled systems have been developed. The reservoir is a core of drug surrounded with a polymer film. The 2nd type, the matrix, is one in which the drug is uniformly distributed through a polymer. In chemically controlled systems, the rate of drug release is regulated by a chemical reaction with the polymer. In solvent activated systems a swelling or osmotic mechanism is involved. Pharmaceutical applications have been made in ocular disease with the Ocusert, a reservoir system for glaucoma therapy and which is not widely used, and in contraception with 4 systems. These systems are: 1) subdermal implants of nonbiodegradable polymers such as Norplant, 6 capsules of 36 mg levonorgestrel; 2) subdermal implant of biodegradable polymers; 3) steroid releasing IUD; and 4) vaginal rings, which are silicone-coated. Other applications have been made in the areas of dentistry, immunization, anticoagulation, cancer, narcotic antogonists, and insulin delivery. Transdermal delivery involves placing a polymeric system containing a contact adhesive on the skin.
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PMID:Implantable controlled release systems. 635 38

430 women enrolled at the time of acceptance in a longitudinal study of Norplant acceptability elected to have their implants removed between May 13, 1991 and September 8, 1994 (within 40 months of insertion). 225 of these women were surveyed immediately after removal, and 205 were identified during the follow-up study. The study provided information sociodemographic characteristics of the women and on 1) contraceptive method used before and after Norplant; 2) concerns about Norplant which were expressed prior to insertion; 3) reasons indicated for having implants removed; 4) changes in bleeding patterns; 5) side effects unrelated to menstrual bleeding; 6) significant pain reported during each of six stages of the removal process; and 7) user satisfaction in terms of comfort, convenience, cost, health effect, insertion, removal, and medical care. Most of the women chose early removal because they were unable to tolerate the side effects, but 13% chose removal because of discomfort at the implantation site and 10% because they no longer desired contraception. Removal was related to a pregnancy in three women (not method failure), and five others were acting on their physicians' advice. 48% of the women reported significant pain during removal, which was a larger number than expected. Since the cost-effectiveness of Norplant depends upon longterm use, it will be helpful to identify women who might be better served by a shorter term contraceptive. Despite the desire for removal, more than 25% of the women stated that they would consider Norplant use again in the future. Because side effects caused most women to discontinue, it is important that patients be properly counseled on the disadvantages of a longterm method.
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PMID:Characteristics and experiences of American women electing for early removal of contraceptive implants. 758 87


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