[Norplant: an effective option for adolescent women. Subdermal implant contraception in adolescent women. Preliminary findings in 174 cases].
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Adolescent↗
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[An implantable contraceptive: Norplant].
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Africa↗
A long-term study of the efficacy and acceptability of a single-rod hormonal contraceptive implant (Implanon) in healthy women in China.
OBJECTIVE: To investigate the contraceptive efficacy, cycle control and acceptability of Implanon, a new single-rod, progestogen-only contraceptive implant. METHODS: In a non-comparative, open, multicenter study, a contraceptive implant containing the progestogen etonogestrel was inserted into 200 healthy women. The study duration was 2 years, with an optional extension up to 4 years. RESULTS: Women were exposed to Implanon for 644.6 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding-spotting days ranged between 18 and 21 and the median number of bleeding-spotting episodes was two. The mean overall incidence of prolonged bleeding fell markedly during the study, from 69% in the first reference period to 26% in the 16th period. The most common adverse events were related to disturbed bleeding pattern and amenorrhea. Heavy or prolonged bleeding caused 18 subjects to withdraw from the study. Only a few subjects discontinued the study early due to irregular bleeding (2%) or amenorrhea (2%). A slight increase in mean body weight was observed. The implant was removed in an average time of 2.9 min. CONCLUSIONS: Implanon demonstrated excellent contraceptive efficacy for 4 years of use and was well tolerated. The incidences of prolonged bleeding and amenorrhea both fell markedly with continued implant use. Because of its single-rod design, Implanon was quickly removed with few complications and proved to be a highly acceptable method of contraception.
Adult↗
A 4-year pilot study on the efficacy and safety of Implanon, a single-rod hormonal contraceptive implant, in healthy women in Thailand.
OBJECTIVE: To investigate the contraceptive efficacy, safety and acceptability of a new single-rod, progestogen-only contraceptive implant (Implanon). METHODS: In an open, non-comparative pilot study, 100 healthy women received a contraceptive implant containing the progestogen etonogestrel (3-ketodesogestrel) for 2 years with an optional extension up to 4 years. RESULTS: Subjects were exposed to Implanon for 296.1 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding-spotting days was 10 and the median number of bleeding-spotting episodes was 2. Amenorrhea occurred in 24-39% of subject during the first 2 years and in about 20% in those who continued in the 3rd and 4th years. The most common drug-related adverse event was headache (7%). A slight increase in body mass index was observed. Only a few subjects discontinued treatment early, due to bleeding irregularities (6%) or amenorrhea (1%). The cumulative discontinuation rates were 13.4% after 2 years, 25.3% after 3 years and 28.0% after 4 years of use. Within 3 months of implant removal, six normal pregnancies occurred, indicating a rapid return of fertility. The average time taken for insertion of the implant was 0.5 min, compared with 2.5 min for removal. CONCLUSIONS: Implanon demonstrated excellent contraceptive efficacy and was well tolerated during up to 4 years of use. The vaginal bleeding pattern was variable and was characterized by relatively few bleeding events, but proved acceptable to most subjects. Because of its single-rod design, Implanon was quickly inserted and removed without complications.
Adult↗
Effects of levonorgestrel-releasing subdermal contraceptive implants on bone density and bone metabolism.
A prospective, randomized clinical trial observed the effects of Norplant long-term contraceptive implants and domestic implants similar to Norplant on bone mineral density and bone metabolism in female acceptors for 1 year. Bone mineral density (BMD) and bone mineral content (BMC) of lumbar 2-4 and proximal femur of 61 normal women of child-bearing age were measured by dual energy x-ray absorptiometry (DEXA) before and 12 months after implants insertion in both groups. BMD and BMC of lumbar 2-4 in both groups 12 months after implant insertion significantly increased (p < 0.01); with an average increase of 2.40% and 3.34%, respectively in the Norplant implant group, and 2.75% and 4.47%, respectively in the domestic implant group. Urine hydroxyproline and creatinine ratio (Hop/Cr) in the domestic implant group significantly decreased (p < 0.01). There was no significant differences in the effects on BMD and BMC of lumbar spine and femur and on bone metabolism between the two groups of contraceptive implants (p > 0.05). Levonorgestrel releasing contraceptive subdermal implants were not deleterious to the skeleton in women of child-bearing age. There was no significant effect on achieving maximum bone mass in young women.
Absorptiometry, Photon↗
Phase II--clinical trial with biodegradable subdermal contraceptive implant Capronor (4.0-cm single implant). Indian Council of Medical Research Task Force on Hormonal Contraception.
The subdermal biodegradable contraceptive implant Capronor (4.0 cm) was implanted in 41 women to observe the efficacy and side effects. Only one pregnancy was reported at 10 months of use, and the life table continuation rate at 12 months was 82.2 per 100 users. No serious clinical side effects were reported during the study period. The menstrual pattern was disrupted during the first 3 months of implant use in two-thirds of the women which improved by the end of 12 months of use. The results of this Phase II study suggest that Capronor is a safe and effective long-acting contraceptive. These findings need to be confirmed in a Phase III clinical trial on a larger sample size.
Adolescent↗
Norplant neuropathy: peripheral neurologic symptoms associated with subdermal contraceptive implants.
Seventy to 80% of women using subdermal contraceptive implants (Norplant) have reported side effects, such as uterine bleeding, headache, mastalgia, and local pain at the site of insertion. This is a report of two patients who presented with peripheral neuropathy associated with the implants. One patient responded to removal of the device. The second patient, whose symptoms were thought to be related to trauma, was successfully treated with nonsteroidal anti-inflammatory agents.
Adult↗
Contraceptive implants and lactation.
The safety and efficacy of four contraceptive implants, plant, Implanon, Nestorone and Elcometrine, have been evaluated during use in the postpartum period by lactating women. These implants provide highly effective contraceptive protection with no negative effect on breastfeeding or infant growth and development. Breastfeeding women initiating Norplant use in the second postpartum month experience significantly longer periods of amenorrhea than do untreated women or intrauterine device users. After weaning, the bleeding pattern is similar to that observed in non-nursing women. Norplant use does not affect bone turnover and density during lactation. Norplant and Implanon release orally active progestins while Nestorone and Elcometrine implants release an orally inactive progestin, which represents an advantage since the infant should be free of steroidal effects. The infant's daily intake of steroids (estimated from concentrations in maternal milk during the first month of use) range from 90 to 100 ng of levonorgestrel (Norplant), 75-120 ng of etonogestrel (Implanon), and 50 ng and 110 ng of Nestorone (Nestorone and Elcometrine implants, respectively). Nursing women needing contraception may use progestin-only implants when nonhormonal methods are not available or acceptable. Implants that deliver orally active steroids should only be used after 6 weeks postpartum to avoid transferring of steroids to the newborn.
Bone Density↗
Ulnar neuropathy associated with subdermal contraceptive implant.
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.
Adult↗
Subdermal contraceptive implant (Norplant) continuation rates among adolescents and adults in a family planning clinic.
STUDY OBJECTIVE: The purpose of this study was to prospectively evaluate the continuation rate of subdermal contraceptive implants (Norplant) among adolescent (< 20 years) and adult (> or = 20 years) women in the clinic population of a tertiary care medical center. DESIGN: Adolescents and adults desiring contraception for greater than a 6-month period were eligible for Norplant insertion. Prior to insertion, personal counseling and extensive education were provided. Following insertion, rapid access, personal counseling, and prompt treatment were provided for complications that occurred. Device removal was available to all individuals at any time upon patient request or if side effects could not be ameliorated. Patient demographic, historical, physical, and follow-up data were entered into a computer data base. RESULTS: Since February 1991, 1800 subdermal contraceptive implants were inserted. Of these 1688 patients were prospectively followed, providing 45,576 women-months of data for analysis. Adolescents comprised 40% of the study population. Over a 50-month period, the cumulative continuation rate for adolescents was 93.6%, and for adults it was 91.1%. The mean duration of use among adolescents was 26.5 months and for adults was 27.6 months. CONCLUSIONS: There was no significant difference between adolescent and adult subdermal contraceptive implant continuation rates for up to 50 months of use. In this patient population, high continuation rates may result from a combination of extensive patient education and intensive surveillance by a well-trained and dedicated multidisciplinary staff. When all patients are enrolled in a program that provides aggressive education and supportive follow-up, age is not a significant factor in continuation rates.
Adolescent↗
Attitudes towards contraceptive implants and injectables among present and former users in Singapore.
In a comparison of present and past users of contraceptive implants (Norplant) or injectables (DMPA) and discontinuers of Norplant or DMPA, information concerning the women's knowledge and perception of, and attitude to, implants and injectable contraceptives, was studied. The long duration of action (5 years) of implants was perceived positively by all groups as compared to the shorter 3-month duration of injectables, though this was seen as an advantage over the pill. It appears that the Norplant system has potential for wider use in Singapore in the future.
Adult↗
Recent developments in contraceptive implants at the Population Council.
Development of contraceptive implant methods, when based on established or on new synthetic chemical entities, is a decadal or multi-decadal process. The process often requires the cooperation of numerous investigators for laboratory work, for early Phase II trials, for dose-finding trials, and for Phase III clinical trials. The Phase III work also requires cooperation with a commercial manufacturer and potential distributor of the product. The Population Council has recently completed developmental work on two levonorgestrel-releasing implants, with filings to regulatory agencies that support extended use of Jadelle implants for 5 years and Norplant implants for 7 years. When the developmental process includes establishing the clinical properties of a molecule not yet approved by regulatory agencies, the minimum development time appears to be two decades. The status and rationale of studies of a new Nestorone-releasing, single implant developed by the Population Council for a period of use of 2 years are presented.
Academies and Institutes↗
Clinical experience and acceptability of the etonogestrel subdermal contraceptive implant.
OBJECTIVE: To evaluate efficacy, adverse effects, and user continuation rate of an etonogestrel subdermal single-rod contraceptive implant. METHODS: A total of 417 healthy volunteers of childbearing age were included in this multicenter trial. After implant insertion, the women were followed up during the 3 years of contraceptive action. At each visit, clinical findings, side effects, and bleeding patterns were recorded. Efficacy and continuation rates were analyzed using the Pearl Index and Kaplan-Meier life tables, respectively. RESULTS: The observation period totaled 958.5 woman-years (27.5 months per woman). The Pearl Index score was 0. Side effects were reported by 44.4% of users, but the proportion had decreased to 16.5% by the end of the study. The continuation rate was 61.4%. The most common reason for early discontinuation (in 21.1% of the participants) was menstrual disturbances. CONCLUSIONS: Etonogestrel subdermal contraceptive implants demonstrated high efficacy and an acceptable continuation rate. Counseling potential users explicitly about the side effects will optimize patient success with this long-acting contraceptive.
Adolescent↗
One-year experience with subdermal contraceptive implants in the United States.
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.
Adolescent↗
Transition from Norplant to Jadelle in a clinic with extensive experience providing contraceptive implants.
OBJECTIVE: The purpose of this study was to understand the transition process from providing Norplant, the six-capsule first contraceptive implant system, to providing Jadelle, the two-rod second-generation system, in a clinical setting with extensive experience providing Norplant implants. MATERIALS AND METHODS: Two hundred forty-nine women requesting contraceptive implants from the PROFAMILIA clinic (Santo Domingo, Dominican Republic) were provided with information regarding the differences and similarities between the two implant systems being studied, including the easier insertion and removal procedures and the possible shorter use life associated with Jadelle. A questionnaire evaluating their preference and the reason why they chose either system was provided. The health care providers' opinions about the two systems were also studied. RESULTS: Fifty-three percent of the women preferred Jadelle over Norplant. The main reason behind their preference for Jadelle was its reduced number of implants with easier insertion and removal and less visibility in the arm, whereas that for Norplant was greater familiarity. Providers overwhelmingly preferred Jadelle. A 1-h presentation was sufficient training for providers experienced with Norplant. None had any problem with the management of Jadelle. CONCLUSION: The inclusion of Jadelle in a clinic with extensive experience with Norplant was easy and uneventful, but both methods should be available during a transition period of several months while confidence in the new method is being acquired by the community.
Attitude of Health Personnel↗
[Levonorgestrel contraceptive implants. Facts and controversies of a current contraceptive method].
Research in the world of birth control technology advance daily. In México we now count with one of the best and most advanced contraceptive methods levonorgestrel implants. Even though it is far from being the ideal anticonceptive. It is in advantage over those known today in this country, because it does not content estrogens, it lasts up to 5 years, its reversible and it can be easily installed in a doctor's office. Some mexican doctors do not recognize yet this product or have been the victims of bad taste advertising. Learning about the method, its indications, contraindications, side effects, correct application and removal technics you can easily end the wrong ideas of it as a problematic device. The objective of the present work is to inform to the medical field of an excellent birth control alternative.
Contraceptive Agents, Female↗
Preventing repeat adolescent pregnancies with early adoption of the contraceptive implant.
CONTEXT: Even in intensive, adolescent-oriented programs, in which access to highly effective contraceptives is guaranteed, repeat adolescent pregnancies commonly occur. METHODS: To assess whether adoption of the contraceptive implant would lower the rate of repeat pregnancy, contraceptive use and pregnancy outcomes were tracked among 309 adolescent mothers--171 "early" implant users who began use within six months of delivery and 138 who either adopted another method or had used no method. Participants were interviewed at delivery and at six-month intervals through the second year postpartum. Multivariate logistic regression analyses were conducted to ascertain the likelihood of a repeat pregnancy within the first and second year postpartum. RESULTS: During the first year postpartum, although 7% of the early implant users had their implants removed, pregnancy rates were significantly (p < .0001) lower among early implant users (less than 1%) than among the other adolescent mothers in the sample (20%). By the end of the second year postpartum, 37% of early implant users had discontinued use. Nevertheless, their two-year pregnancy rate (12%) remained significantly lower (p < .0001) than that of the other adolescent mothers (46%). The multivariate analysis showed that early implant use was the only independent predictor of a repeat pregnancy within the first year postpartum, while early use, parity and number of risk factors for repeat pregnancy were independently associated with the likelihood of another pregnancy in the second year postpartum. CONCLUSIONS: Although early implant insertion significantly decreased the rate of rapid, repeat adolescent pregnancies, the rates of removal and of pregnancy by the end of the second year postpartum were high. Thus, health care providers need to address the motivational components of adolescent pregnancy even among those who accept ostensibly long-term methods.
Adolescent↗
Serum lipids, blood pressure, body weight, and serum chemistry in women using subcutaneous contraceptive implants releasing the progestin ST 1435.
OBJECTIVE: To study the changes in serum lipids, serum chemistry, blood pressure, and body weight in long-term users of subcutaneous contraceptive implants releasing the progestin ST 1435. METHODS: The study was done in the outpatient clinic of the City Maternity Hospital, Helsinki, Finland. Subdermal implants releasing the progestin ST 1435 were inserted in 30 women for 2 years of use. Healthy women aged 19-35 used the implants for contraception. Measurements of body weight and blood pressure were made and blood samples for lipid analysis (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides) and serum chemistry were taken before insertion of the implants and every 6 months thereafter until removal. Results are reported for 30 subjects after 6 months of use, 25 subjects after 12 months, 13 after 18 months, and 12 after 24 months. RESULTS: Blood pressure and serum chemistry, ie, liver enzymes and electrolytes, remained unchanged. Slight weight gain occurred, but was not statistically significant. No statistically significant changes were found in lipids or lipid ratios when comparing the values during use of the implant with the pre-treatment values. CONCLUSIONS: The progestin ST 1435, used parenterally for contraception or progestin therapy, had no adverse effects on serum lipids, blood pressure, or body weight, which are known to be risk factors for coronary artery disease. The steroid had no effects on serum chemistry determinations in long-term use.
Adult↗