Women who received Norplant contraceptive implants from any of fifteen clinical settings in southeast Texas, U.S.A., were followed for one year to determine their reactions to the method. Of 1,385 who enrolled to receive Norplant implants, 1,253 had implants inserted. Side effects were reported by 78% of those receiving implants and 70% described changes in bleeding patterns. Spotting or irregular bleeding, weight gain and headaches were the conditions reported most frequently. Nine pregnancies were reported during the study period. Six of these, however, existed before the implants were inserted. At the one year anniversary, 143 of women receiving implants had had them removed. Those who discontinued method use were less satisfied, reported more side effects and were more likely to have planned to have another child, thus using the method for spacing, or to have had a change in their marital status while they were using the contraceptive. Providers should counsel patients to focus attention on plans for the future in selecting their contraceptive method. In addition, we recommend, as does the product's distributor, that providers confirm that patients are not pregnant prior to inserting implants.

The question of differential effects on bone density by two different types of progestogen-only methods for contraception in premenopausal women was addressed. Data from a prospective randomized clinical trial among 22 premenopausal women, age 32.6 (range 20-45 years), who were randomly assigned to either of two treatments with continuous progestogens for contraception were analyzed; depot-medroxyprogesterone acetate (DMPA) or continuous levonorgestrel treatment with subdermal implants (Norplant), respectively. Forearm bone density (BMDprox) increased with 2.94% (p = 0.006) in women who were prescribed levonorgestrel, which was in contrast to stable values in those prescribed depot-medroxy-progesterone acetate; group difference at 6 months for BMDprox 3.4% (95% CI 1.3, 5.5; p = 0.025) and BMDdist 4.1% (95% CI - 1.3, 9.6; p = 0.077). The changes in bone density were consistent with the changes in biochemical indices for bone metabolism; DMPA users showed signs of increased bone turnover and users of levonorgestrel showed increased bone formation with increased levels of both alkaline phosphatase (p = 0.004) and osteocalcin (p = 0.007). The findings suggest an increase in bone density during treatment with levonorgestrel and stable values during short-term administration of DMPA, in standard clinical doses for contraception.

Forty-seven normal health women were studied longitudinally for changes in liver functions during the use of the levonorgestrel contraceptive implant system, NORPLANT. Samples were collected before insertion of the implants and after one, three and six months of use. The enzymes studied were the transaminases (SGOT and SGPT), alkaline phosphatase and gamma-glutamyl transferase. Serum bilirubin and bile acid levels were also measured. The protein synthetic function of the liver was tested by estimation of total proteins, albumin, transferrin, hemopexin, ceruloplasmin and haptoglobin. The three main immunoglobulins, G, M and A, were also measured. There were no significant changes in the liver enzymes after NORPLANT use. Serum bilirubin and bile acid concentrations showed rises in the first month of use which ameliorated in subsequent months. Serum albumin was transiently increased during the first and third months. Ceruloplasmin decreased significantly at the sixth month. The concentrations of total serum proteins and the other individual proteins showed no significant change. The results point to safety of NORPLANT implant use, as regards hepatic functions.

Progestin-only contraceptives are associated with breakthrough bleeding in up to 50% of users. The causes of blood vessel rupture are not well understood. Here we report that both normal and Norplant-exposed endothelium express progesterone receptor. Experiments performed in vitro on endothelial cells isolated from human endometrium revealed that longterm progesterone exposure leads to suppression of endothelial cell proliferation, inhibition of migration and alteration in the profile of extracellular matrix proteins secreted by human endometrial endothelial cells. In addition, we detected increased levels of matrix metalloproteinase-9 in endothelial cultures treated with progesterone. The effect of progesterone on the cell cycle, along with the increased amounts of matrix-degrading enzymes, could account for breakdown of basement membrane components, vascular fragility and consequent vessel rupture leading to breakthrough endometrial bleeding.

Norplant offers long-term contraception through the use of subdermal capsules filled with levonorgestrel. The six capsules are implanted in the inside part of the upper arm. The levonorgestrel is released from the capsules gradually, providing contraception for about 5 years. The primary mechanism of action of Norplant is suppression of ovulation. Studies have shown a pregnancy rate of 0.6/100 woman-years after 1 year and a cumulative rate of 1.5/100 woman-years at 5 years. Principal side effects are irregular menstrual bleeding and headaches. No changes in carbohydrate metabolism, blood coagulation, or liver function have been reported. Lipid levels have decreased 5% to 15%. After removal of Norplant, fertility returns rapidly, and there have been no adverse effects on infants. Norplant is currently approved in 12 countries; clinical trials are being conducted in 37 countries.

More research on the effect of exogenous progestins on breast cancer risk is clearly needed. Biologic evidence that progestins may act synergistically with estrogen to enhance proliferation of breast epithelial cells emphasizes the importance of further exploration of this issue, particularly given the increasing prevalence of exposure to contraceptive and noncontraceptive progestins. No specific type or dose of progestin in monophasic combination oral contraceptives has been linked to breast cancer. Based on the few epidemiologic studies of progestin-only oral contraceptives, there also is no evidence that they increase risk of breast cancer. Two studies found that longer-term use of progestin-only pills was associated with a decreased risk of breast cancer. However, given the low prevalence of use of minipills, it is unlikely that this exposure substantially affects the incidence of breast cancer in the population as a whole. Use of the injectable contraceptive DMPA has been positively associated with risk of breast cancer in some subgroups of women, although no significant overall adverse effect has been observed in the two largest studies conducted to date. There is suggestive evidence that use at an early age or prior to a first term birth and recent use may increase risk of breast cancer. It remains unclear, however, whether or not surveillance bias may explain the positive association observed in recent users. Additional research on DMPA and breast cancer incidence is needed, since studies published to date have lacked sufficient power to evaluate risk in relation to long-term use. Future studies of breast cancer in relation to use of other long-acting progestational agents such as Norplant will also be important. There is concern about the relation between breast cancer incidence and use of combined estrogen-progestin replacement therapy, especially extended periods of use. At the present time, only one study (45) has estimated risk according to duration of use, and it remains uncertain whether the reported elevation in risk seen in long-term users of combined therapy is due to enhanced surveillance for breast cancer among exposed women. Further research will be required before any definitive conclusions can be reached about the potential effect of estrogen-progestin replacement regimens on breast cancer incidence. Future studies should attempt to determine the circumstances under which progestins may alter risk of breast cancer and whether such effects vary by duration of use, dosage, type of preparation, concomitant use of estrogens, regimen of exposure, and the timing of progestin use in relation to age and menstrual and reproductive events.(ABSTRACT TRUNCATED AT 400 WORDS)

BACKGROUND

Norplant is a long-acting subdermal implant system that is widely used for contraception. The implant releases a continuous dose of levonorgestrel, a synthetic progestin. Although oral contraceptives are associated with depression and panic disorder, no cases have been reported of psychiatric disorders secondary to the use of Norplant.

METHODS

Two women, aged 18 and 29 years, are described who developed major depression and panic disorder while using the Norplant system.

RESULTS

These women who had no prior psychiatric history developed major depression and panic disorder 1 to 2 months after insertion of Norplant system capsules. The symptoms worsened over the course of a year. Following removal of Norplant, the symptoms of depression and anxiety resolved within 1 month.

CONCLUSIONS

The progesterone content of oral contraceptives has been linked to major depression and panic disorder. Since Norplant is a progestin-only preparation, it is likely that some women will develop these disorders. These cases illustrate the importance of careful follow-up for adolescents and adults who select Norplant for contraception. Patients should be informed about the possible occurrence of psychiatric disorders. When evaluating new onset of depression and panic disorder in adolescent and adult women, it is important to inquire about Norplant insertion.

A 5-year trial of a two-rod contraceptive implant, which releases the progestin levonorgestrel (LNG rod), was conducted at four clinics with 594 women. Mean age and weight at admission were 25.5 years and 62.4 kg, respectively. Consent to continue through 5 years was sought and obtained when the 3-year cumulative pregnancy rate proved to be 0.8 per 100. No pregnancies occurred in the fourth or fifth years. The 5-year cumulative pregnancy rate was, therefore, 0.8 per 100 with an annual average pregnancy rate below 2 per 1000 women. Prolonged bleeding/spotting (8.2% of subjects) and irregular bleeding (5.6%) were the most frequently cited medical reasons for removal. Removals for headache (4.7%) and weight change (4.0%) were the next most frequent medical reasons. Between 1% and 2% of subjects during the 5-year trial sought removals for each of the following conditions: mood changes, lower abdominal pain, depression, or pain at the implant site. The mean annual continuation rate during the study was 77 per 100. Use per woman averaged 2.96 years. Mean removal time was 5.9 +/- 0.6 min. These data indicate that, for a 5-year period, the two LNG rod implants are equivalent to the six Norplant capsule implants with respect to safety and efficacy parameters, but permit easier and more rapid implant removal.

The objective of this study was to test the influence of NORPLANT implants upon lactation and infant growth. The results obtained during the first postpartum year are reported. One-hundred women were enrolled in the implant group. The control group was formed by 100 women who received a Copper T IUD. Treatments were administered at day 55 +/- 3. At admission all subjects were in exclusive breastfeeding with an adequate weight increase of the infant. No significant differences were found between the treated and control groups in the percentage of women in full nursing at different postpartum intervals, except for the 12th month postpartum where a lower percentage of cases from the NORPLANT group was in the full nursing category. No difference was found in the time of weaning. The infants showed a normal weight gain rate in both groups although the girls from the NORPLANT group showed a significantly lower daily weight increase during the 4th month than the girls from the IUD group. No pregnancies were diagnosed. No women asked for implant removal during the first year. No serious side effects related to treatment were detected. Bleeding irregularities were rare during breastfeeding which is in contrast with what occurs in non-nursing women treated with NORPLANT implants. Levonorgestrel concentrations found in milk were variable and individual values ranged from 23 to 311 pg/ml. The dose received by the infant can be estimated around 15 to 18 ng/Kg/day during the first month of treatment when the higher plasma values of levonorgestrel are observed. These levels is conjunction with the clinical observations reported here minimize the potential problems associated with levonorgestrel transference through maternal milk. Nevertheless, long-term studies are required to settle this matter and until more information is available, NORPLANT implant use in lactating women should be limited to cases who require a highly effective contraceptive method and where non-hormonal methods of similar effectiveness are contraindicated or unacceptable.

The vaginal bleeding patterns observed during the use of the single-rod progestin-only implant, Implanon, compared with those seen during the use of the six-capsule implant, Norplant, have been analyzed. The acceptability of these bleeding patterns was also assessed. An integrated analysis of 13 different trials was done, studying reference periods (RP) of 90 days. These trials included totals of 1716 Implanon users and 689 Norplant users. There were statistically significant lower mean values over RP 2-8 the range over RP 2-8 is presented) for Implanon, for the number of bleeding-spotting days (15.9-19.3 vs 19.4-21.6; p = 0.0169), the number of bleeding days (7.5-10.0 vs. 11.7-13.1; p < 0.001), and the number of bleeding-spotting episodes (2.2-2.7 vs. 3.1-3.3; p < 0.0001). The bleeding patterns of Implanon users appeared to be more variable than those observed with Norplant: Implanon users had more amenorrhea, and slightly more infrequent bleeding, frequent bleeding, and prolonged bleeding than Norplant users. The difference was only statistically significant for amenorrhea (17.9%-24.8% with Implanon compared with 2.0%-7.0% for Norplant over RP 2-8). There were no statistically significant differences in the acceptability of the two products as indicated by the discontinuation rates, which were 30.2% and 0.9% in Europe and Southeast Asia, respectively, for Implanon, and 22.5% and 1.4%, respectively, in the two regions, for Norplant. The individual bleeding pattern was not predictable. However, in general, it can be stated that women initially without bleeding or with infrequent bleeding have only a small chance of becoming frequent bleeders, and vice versa. Dysmenorrhea clearly improved during use of both Implanon and Norplant. Neither Implanon nor Norplant caused anemia.

The subject of this study to examine the safety and contraceptive efficacy of Norplant, we undertook a 5-year study of follow-up of women initiating use of Norplant, intrauterine device (IUD) or sterilization in eight developing countries. Women attending family clinics were enrolled if they consented and were medically eligible to use Norplant, IUD, or female sterilization. Women who chose to initiate use of IUDs or surgical sterilization served as controls and were frequency matched in 5-year age-bands with women who chose to use Norplant. At admission women had a physical examination, and their medical histories, demographic, and socio-economic characteristics were recorded. Follow-up visits were scheduled in the first 6 weeks after admission and semi-annually thereafter for 5 years irrespective of change of contraceptive method. Incidence rate ratios of health events were estimated for initial and current contraceptive method use. This paper reports reproductive health events and contraceptive efficacy. Altogether, 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of surgical sterilization were admitted. Their mean ages at initiation were 28.5, 28.5, and 29.6 years, respectively. More than 99% were married or cohabiting, and parous. Five-year follow-up was completed by 94.6% of the women. By the end of 5 years, the mean duration of first segment use per initiator was 4.16 years for Norplant, 4.10 years for IUDs, and 4.96 years for sterilization accounting for 39,337 woman-years for Norplant, 31,915 for IUDs, and 7,071 for sterilization. The study accumulated 78,323 woman-years of observation. Pearl pregnancy rates for Norplant, copper IUDs and female sterilization were 0.27, 0.88, and 0.17 per 100 woman-years, respectively. Users of Norplant, copper IUDs, and sterilization had rates of ectopic pregnancy of 0.30, 0.68, and 0.13 per 1,000 woman-years, respectively. Major health events related to the reproductive system were rare. Rates of acute PID were significantly lower among Norplant users than IUD users (p = 0.004). The rate of ovarian enlargement was significantly higher in Norplant users than controls (p <0.001), but not rates of hospitalization for this condition. Vaginitis and vaginal discharge, and low abdominal pain were significantly less frequent in Norplant users than in the other groups. Bleeding disturbances were more frequent among Norplant users than controls but not anemia. The study confirms the high contraceptive efficacy of Norplant, copper IUDs, and female sterilization. The incidence rates of major reproductive health problems were low. There was no significant excess of serious reproductive morbidity among users of Norplant compared to users of IUDs and sterilization.

Side effects are a common occurrence in the use of subdermal contraceptive implants (Norplant); approximately 70% to 80% of women using the device report abnormal uterine bleeding, headaches, acne, mastalgia, nervousness, appetite changes, and weight gain. Local implant site reactions range from 0.4% to 4.7%, with pain being the most common. Other insertion site complications include infection and implant expulsion. Only three cases have been described in the literature concerning implant site-related neuropathy, involving the sensory branch of the musculocutaneous nerve (lateral cutaneous nerve) in two cases and the antebrachial cutaneous nerve in the third case. We believe our report is the first case of an axonal loosing motor and sensory ulnar neuropathy associated with the removal of a subdermal contraceptive implant (Norplant). We review insertion site complications and their most likely causes. Also, we discuss alternative removal techniques for difficult-to-remove implants.

Subdermal implants are contraceptive systems that release low, stable amounts of synthetic progestins from Silastic or other materials for periods of months to several years. Unlike other hormonal delivery systems, they do not cause unnecessary peaks in progestin levels and do not use estrogens, and thus their health risks are minimal. Norplant has been studied more extensively than any other subdermal contraceptive implant. More than 60,000 women have participated in clinical trials, which demonstrated that this approach is one of the most effective reversible contraceptive methods available (1% pregnancy rate in 5-year users). The implant also reduces the incidence of ectopic pregnancy to a level much below noncontraceptive users and about equivalent to TCu380A intrauterine device users. Exposure to the sustained, low dose of levonorgestrel delivered by Norplant has shown only minor metabolic changes. Side effects are minor but often bothersome, causing some discontinuation of the method. First-year continuation rates range from 76% to 90%. Fertility return after discontinuation is prompt. Difficulty in removal of the implant capsules by the less experienced practitioner has motivated researchers to develop systems that are easier to use, less obvious under the skin, and biodegradable. The Norplant 2 system is faster, easier, and less painful to insert and remove. Implants under investigation release desogestrel and other progestins; Capronor and subdermal norethindrone pellets are biodegradable systems.

This paper reviews pharmacokinetic and pharmacodynamic studies with Implanon, which provides serum etonogestrel levels sufficient to inhibit ovulation within 8 h of insertion. After a peak of 813 pg/ml at 4 days, levels reach steady state (200 pg/ml) after 4-6 months and remain sufficient to prevent ovulation for 3 years. Variability is lower than with Norplant. Etonogestrel levels are similar in most ethnic groups, but 40% higher in women weighing < 50 kg. After implant removal, etonogestrel is not detectable within 1 week. Implanon inhibits ovulation by preventing the mid-cycle luteinizing hormone peak. Although it initially suppresses follicular development and estradiol production, ovarian activity slowly increases after 6 months, and follicle stimulating hormone and estradiol levels are almost normal. Endogenous progesterone levels remain in the subovulatory range for>> 3 years in most subjects. In ovarian ultrasound studies, ovulation occurred in < 5% of users after 30 months of use. Ovulation was observed in most women within 3-4 weeks of implant removal. The pharmacokinetics and pharmacodynamics of Implanon indicate that it has high contraceptive efficacy, as reflected in a zero pregnancy rate over 5,629 woman-years of use. Its excellent reliability, ease of use, and reversibility make Implanon a valuable addition to current contraceptives.

This study aimed to investigate the effects of the subdermal levonorgestrel contraceptive implant Norplant on endometrial vascular density at different durations of exposure, and the relationship between endometrial histology, vascular density, and bleeding patterns. A prospective controlled trial of Norplant implant users compared endometrial vascular density in biopsies taken before and after Norplant implant insertion. A total of 34 women with regular menstrual cycles requesting long-term contraception were recruited at the Sydney Centre for Reproductive Health Research, Australia. A significant increase in mean endometrial microvascular density was observed from as early as 3 weeks after insertion of Norplant implants. Vascular density was increased from a control secretory phase value of 189.6 (7.0 vessels/mm2 (+/- SEM) to 253.80 +/- 7 vessels/mm2 at 2-13 weeks of Norplant implant exposure (t ratio = 2.08, p = 0.01) and 212.7 +/- 12.9 vessels/mm2 at 14-42 weeks of exposure (t ratio = 2.03, p = 0.02). In those with atrophic endometrium, or in whom myometrium and basalis only were found in biopsies (20 of 66, 30%), mean endometrial vascular density was increased at 273.1 +/- 16.1 vessels/mm2 compared with 210.9 +/- 11.7 vessels/mm2 in other histological groups (F ratio = 9.74, p = 0.0028). Bleeding and spotting in the previous 30 days were less common in those with this histological appearance at a mean of 4.95 days compared with 8.22 days. This is the first study to assess endometrial vascular density in the early months of Norplant implant use. The findings suggest that the endometrial vasculature is profoundly altered in the early months of Norplant implant exposure when bleeding problems are most common.

This report describes the long-term follow-up of 376 women who received NORPLANT implants in the period October 1974 through May 1979. One-hundred-and-ten subjects received replacement implants after variable lengths of use of the first set. The average levonorgestrel plasma levels declined steadily through eight years of use of NORPLANT capsules (r = -.937). Values were 0.35 ng/ml, 0.29 ng/ml and 0.22 ng/ml at treatment years 1, 5 and 8, respectively. Levonorgestrel plasma levels after replacement with a second set of implants were similar to those observed after the first insertion, either when placed in the same site as the first set or in a different area. Nineteen pregnancies occurred during 18,530 woman-months of use of the first set of implants, eleven of them during years 6 through 8 of treatment. The Pearl Index for the first 5 years of NORPLANT implants use was 0.63. No pregnancy has occurred in 4194 woman-months observed during treatment with a second set of capsules. Fifty-six women (14.9%) out of 376 acceptors of the first implant and 10 (9.1%) out of 110 acceptors of the replacement implants were terminated for other medical reasons, mainly bleeding problems and side effects commonly associated with hormonal contraception. Two women died while using NORPLANT implants, one of a cardiac arrest after surgery for a gallbladder disease and one because of endocranial hypertension originating from the rupture of an aneurism of the median cerebral artery. The bleeding pattern observed in the three months after NORPLANT capsules replacement was similar to that observed in the 90 days before replacement and different from that experienced by the same women in the first 90 days of implant use. This finding can be interpreted as an indicator of adaptive changes experienced by the target organs during long-term continuous administration of levonorgestrel. The prompt recovery of fertility after removal of NORPLANT implants suggests that these changes are reversible.

We assessed the influence of hormonal (oral, injectable, or levonorgestrel [Norplant, Wyeth-Ayerst, Philadelphia, PA]) and barrier methods of contraception on the risk of cervical squamous intraepithelial lesions (SIL), while adjusting for high-risk (HR) HPV infection. Subjects were women receiving family planning services through the state health department clinics from 1995 to 1998. We selected 60 cases with high-grade cervical/SIL (HSIL) and 316 with low-grade cervical/SIL (LSIL) and controls (427 women with normal cervical cytology) and analyzed cervical DNA for HR-HPV, using Hybrid Capture I (Digene; Gaithersburg, MD). When assessing ever use, duration, recency, latency, and age at first use, neither oral contraceptives (OC), Norplant, nor injectable use was associated with an increased risk of SIL development after adjusting for age, age at first sexual intercourse, and HR-HPV positivity. Among HR-HPV-positive women, longer duration barrier method use was associated with a reduced risk of SIL. This finding has important clinical implications for SIL prevention among HR-HPV-infected women.

A pilot study of the effect of husband counseling on NORPLANT contraceptive acceptability was conducted at four family planning clinics in Bangladesh. The study objectives were to compare discontinuation rates and user satisfaction among acceptors whose husbands received counseling about the method versus those who did not. Of a total 617 subjects enrolled in the study which began in 1988, about two-thirds (408) of the husbands were counseled at admission or at the one-month follow-up visit while the remainder of the husbands (209) were not counseled. Follow-up visits were scheduled at one and six months after NORPLANT implants insertion, and every six months thereafter until the close of the study in 1991. Some evidence was found that counseling husbands of NORPLANT implants acceptors may reduce discontinuation rates. At the end of 36 months, a difference of 10 percentage points in total discontinuation rates was observed between the husband-counseled group (32 per 100 women) and the husband-not-counseled group (42 per 100 women). The husband counseling had the most impact at clinics with higher discontinuation rates. Based on Cox's proportional hazards regression model results, the hazard for discontinuation among the acceptors in the husband-not-counseled group. Satisfaction with NORPLANT implants did not differ between the two groups. Although these results are not striking, they do suggest a potential positive effect of husband counseling on NORPLANT contraceptive accept-ability. In future studies, the counseling of husbands should be more intensive and standardized.

This prospective cohort study of 257 rural Zimbabwean women was designed to compare patient satisfaction with levonorgestrel subdermal implants (Norplant and reg;) versus tubal ligation (TL) as a method of long-term contraception. Women were equally satisfied with both methods. At 1 year, 96% of Norplant users and 97% of the TL group reported being "satisfied" or "very satisfied," and 98% of Norplant users, and 99% of the TL cohort would recommend their chosen method to a friend or relative. Rating scores at both 6 months and 1 year were high and equal, with women in each cohort rating their method, on average, as 9 out of 10. Norplant users were significantly more likely to rate birth spacing as a reason for satisfaction with their method, whereas women in the TL cohort were more likely to select multiparity. The 1-year continuation rate with Norplant was 90%, with 4% discontinuing in order to have more children. Selecting the most appropriate method depends primarily on the potential desire of the woman to have more children.

Norplant implants are a long-term, reversible hormonal method of contraception consisting of six flexible capsules placed subdermally in the inner aspect of the non-dominant arm. Norplant implants were introduced into the UK in October 1993 although they had been used previously in some countries for up to ten years. The insertion and removal techniques require skills training and therefore it is important to assess early experience with the method. This survey looks at the first year continuation rate of Norplant implants in the UK from a total of 2,129 insertions. From these insertions, 133 removals were documented and described, using a checklist of features. The continuation rate for Norplant implants use was 96.5% at six months and 85.2% at one year. None of the reasons for discontinuation were of a serious nature. The most common reason given was menstrual change (50.4% of all removals, 3% of all women included in the survey), which is in line with other reported studies. Of the removals, 71.5% were reported as straightforward (of these 65.6% were completed within 20 minutes). In the first year of use, Norplant implants were associated with high continuation rates and the removal procedure was, in the majority of cases, completely straightforward.

Plasma concentrations of levonorgestrel were determined in women using subdermal levonorgestrel implants. One group had 6 Silastic capsules (NORPLANT), one group had 4 and one group had 6 covered Silastic rods for variable lengths of time. Levonorgestrel concentrations remained constant around 0.4 ng/ml up until 6 years of use in the Norplant group. The observation period was shorter for the covered rods; plasma concentrations were, however, constant around 0.55 ng/ml and 0.70 ng/ml for 3.5 years with the 4 rods and 6 covered rods, respectively. The difference in mean levonorgestrel concentrations between the three groups were statistically significant (p less than 0.0005). Plasma levels of levonorgestrel were twice to three times higher in blood obtained from the arm with the implants compared to the levels found in the other arm. The application of a tourniquet for variable periods before blood sampling did not influence the plasma concentrations of levonorgestrel.

BACKGROUND

Adolescents are frequent users of hormonal contraception (HC), yet their adherence to these methods is often poor. Concerns about side effects, especially those affecting the menstrual system, are often given as reasons for contraceptive nonadherence or discontinuation. We sought to identify teens' concerns and misperceptions about the menstrual-related side effects of HC.

METHODS

Open focus groups were conducted with both sexually active and virgin adolescent women aged 12-18 years who were recruited from the Philadelphia area. The adolescents did not have to be contraceptive users in order to participate. The question put to each group was, "What are the things you have heard about the birth control pill, Depo-Provera and Norplant?" Groups were audio-recorded, transcribed and analyzed using qualitative software.

RESULTS

We conducted 13 female-only groups. Participants raised frequent concerns about menstrual-related side effects, believing that these side effects were evidence of possible negative effects of HC on their reproductive health. Four themes related to hormonal contraceptive-induced menstrual irregularity emerged from the groups. Theme 1: Menstruation is natural and should not be altered in any way. Theme 2: The menstrual period is necessary for cleansing of the body. Theme 3: "Spotting," intermenstrual bleeding and amenorrhea cause doubts about the method's effectiveness and worries about pregnancy. Theme 4: All menstrual irregularity, from intermenstrual bleeding to amenorrhea, causes worry about the effects on fertility and on physical health.

CONCLUSIONS

Teens have concerns about the menstrual irregularity caused by HC. Providers understand that these side effects are minor and of little medical consequence. Yet, adolescent patients may be ascribing great significance to these effects and may be declining these methods because of fear and misperceptions.