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PubMed1985

Effect of early postpartum use of the contraceptive implants, NORPLANT, on the serum levels of immunoglobulins of the mothers and their breastfed infants.

Ten breastfeeding women had the contraceptive implants NORPLANT inserted between days 30 and 39 postpartum. The immunoglobulins IgG, IgM and IgA were measured in the serum of the mothers and the infants before insertion and five months later. A control group of breastfeeding mothers who did not use any contraception or used local barrier methods were similarly studied. Although there were changes in the immunoglobulin levels with time in both mothers and infants, there were no group differences; this indicates that the use of NORPLANT does not influence these factors of humoral immunity.

Adult↗

PubMed1985

Influence of levonorgestrel contraceptive implants, NORPLANT, initiated early postpartum upon lactation and infant growth.

This study was undertaken to investigate the effect of use of levonorgestrel contraceptive implants, NORPLANT, by breastfeeding mothers on lactational performance and infant growth. NORPLANT implants were inserted between days 30 and 42 postpartum in 50 lactating women. Two control groups of breastfeeding mothers, 50 each, were studied in parallel: the first used an intrauterine device (Cu T380-Ag) and the second used either barrier or no contraception. There was no difference in lactational performance among the three groups. The increments in infant weight and height in the three groups were within the normal range for Egyptian infants. However, the rates of weight and height gain in the early postpartum months were slightly, but significantly, lower in the NORPLANT group than in the two control groups. However, by the sixth postpartum month, there were no significant group differences in these growth parameters. The possible confusing effect of supplementary feeding is discussed.

Adult↗

PubMed1995

Characteristics and experiences of American women electing for early removal of contraceptive implants.

The study describes the experiences of 430 women who had Norplant(R) contraceptive implants removed prior to the five years of method effectiveness. Each subject was surveyed when the implants were inserted and again at the time of removal. Descriptive data are presented concerning perceptions of the method before insertion and after removal, reactions to the contraceptive and experiences associated with the removal procedure. Subjects' use of Norplant implants ranged from 14 days to 40 months, with a mean of 13.3 and median of 13 months. Over 95% reported changes in menstrual bleeding patterns and 95% experienced other non-bleeding related side effects. Non-bleeding side effects were the most frequently indicated reasons for removal, followed by bleeding changes. The mean removal time was 34 minutes with a median of 25 minutes. Over 48% reported experiencing significant pain during the removal procedure, and 27% stated that the pain was greater than expected. Despite electing for early removal of implants,the majority of women surveyed indicated satisfaction with all aspects of the method save its effect on their overall health. Although method-related side effects were intolerable for most subjects, their overall perception of the method was generally satisfactory.

Adolescent↗

PubMed1995

Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance.

OBJECTIVE: Our purpose was to determine the safety and tolerance of levonorgestrel contraceptive implants (Norplant, Wyeth-Ayerst, Philadelphia) when inserted immediately post partum, to document the effects on weight and blood pressure, and to determine the side effects. STUDY DESIGN: After vaginal delivery, 250 women were randomized to receive Norplant within 48 hours of delivery (study group) or at the 4- to 6-week postpartum visit (control group). Baseline measurements were recorded and compared with those obtained at the 4- to 6-week follow-up visit. A diary was maintained by patients who recorded bleeding and side effects. Statistical analysis was performed with t test and chi 2 analysis. RESULTS: There were no episodes of acute postpartum hemorrhage or clinically significant bleeding. Compared with the control group, the immediate group reported significantly more bleeding days (p < 0.01). There was no significant difference between the two groups in the hemoglobin values obtained at 4 to 6 weeks post partum. The immediate insertion group reported significantly more headaches (p < 0.01) and acne (p = 0.01). CONCLUSION: Norplant is well tolerated and should be available for interested patients immediately post partum.

Acne Vulgaris↗

PubMed1998

The performance of levonorgestrel rod and Norplant contraceptive implants: a 5 year randomized study.

A new contraceptive (LNG rod implants, Jadelle, Leiras Oy's registered trademark for rod implants) was prospectively evaluated in randomized 5 year comparison with Norplant (Population Council's registered trademark for contraceptive implants releasing levonorgestrel) capsule implants. The study involved 1198 women at seven centres. No pregnancies occurred in the first 4 years. At 5 years, the cumulative pregnancy rate was 1 per 100 users or less for each regimen. Annual discontinuation rates averaged 11-12 per 100 users (P > 0.05), corresponding to 5 year continuation rates of 55.1 for rods and 53.0 per 100 for capsules. Mean annual discontinuation rates for menstrual disturbances were 3.5 and 4.2 per 100 for rod and capsule implants respectively (P > 0.05), and mean annual removal rates for medical problems were 3.5 and 3.0 per 100 (P > 0.05) respectively. Apart from menstrual problems, headache, weight gain and acne were the principal medical reasons for removal. In proportional hazard analyses, family formation variables, age, parity and desire/non desire for another child, recorded at admission, significantly affected discontinuation rates for major decrement categories and for all reasons combined. Mean rod removal time was half that of Norplant (P < 0.01); complications of rod removal were at a lower rate. With these contraceptives indistinguishable in performance except for ease and speed of removal, LNG rod implants appear to be preferable to Norplant for use through 5 years by virtue of relative ease of removal.

Adult↗

PubMed2004

Implant contraception in Singaporean women: one decade of experience in KK Women's and Children's Hospital.

INTRODUCTION: The aim of this study was to assess user acceptability and effectiveness of implant contraception in Singaporean women. METHODS: A prospective study was carried out on 553 patients who received Norplant implant in our hospital from 1 January 1992 to 31 December 2000, and followed-up till 15 July 2003. The patients' profile, side-effects, satisfaction and continuation rate of Norplant implant were studied. RESULTS: The mean age of the subjects was 29.4 (plus or minus 5.1) years. The mean parity was 2.1 (plus or minus 1) live births. More than one-half (55.2 percent) of the subjects had used other methods of contraception before. The main reason for them to switch to implant contraception was convenience (63.6 percent). Of the 516 users on follow-up, the common side-effects were menstrual irregularity (51 percent), secondary amenorrhoea (9.6 percent) and weight gain (15.7 percent). 29.3 percent of users did not experience any side-effect. There was only one contraceptive failure, which may be related to drug interaction. The Pearl Index was 0.054 per hundred women years. There was only one serious adverse event of a patient (0.2 percent) who developed severe hypertension requiring treatment. The continuation rate was 92.4 percent after one year, 80.8 percent after two years, 68.9 percent after three years and 58.5 percent after four years. The main reasons for early implant removal were side-effects and desire for future pregnancy. Re-insertion was carried out in 53.7 percent of users who had completed five years of Norplant contraception. CONCLUSION: This largest sub-dermal hormonal implant contraception study in multi-racial Singapore showed that Norplant contraception had a high degree of effectiveness with relatively high user satisfaction and continuation rate.

Adult↗

PubMed2002

Nonmenstrual adverse events during use of implantable contraceptives for women: data from clinical trials.

Contraceptive methods, including implants, do not prevent common symptoms and adverse health events that most people experience. It is difficult, therefore, to decide whether or not the occurrence of symptoms or adverse events that are common can be attributed to use of a contraceptive method or to determine if a given method changes the likelihood of their occurrence. Based on the review of the literature, no apparent differences in the frequency of adverse events are evident between the six-implant or two-rod levonorgestrel systems and the single implant etonogestrel and nomegestrol acetate systems. The most frequent adverse events reported in clinical trials that are probably related to implant use are headaches and acne. Weight gain, dizziness, and mood changes are also frequently mentioned adverse events and are possibly steroid-related. Other possibly related adverse events, although much less frequently reported, are loss of libido, fatigue, hair loss, and other skin conditions. Persistent ovarian follicles that spontaneously disappear are a common event during use of progestin-only contraceptives, and providers should be aware of this condition to avoid unnecessary interventions. Overall, the vast experience reported in the clinical studies reviewed here show that all existing implantable contraceptives are equally safe. This can probably be attributed to the low-hormonal dose delivered by progestin-implant systems.

Abdominal Pain↗

PubMed1993

NORPLANT: levonorgestrel-releasing contraceptive implant.

NORPLANT is the newest contraceptive system to be introduced world-wide, with nearly a million current users. It consists of six Silastic capsules containing levonorgestrel (LNg), which are inserted under the skin in the arm. Release of the steroid commences immediately so that, after several weeks, circulating levels of LNg stabilize between 0.3 and 0.4 ng/ml of plasma, and they persist elevated with a minor decline for over 5 years. The gross cumulative pregnancy rate at 5 years is 2.6 per 100 woman-years. In the majority of women it produces no abnormalities in a variety of clinical chemistry, metabolic, haematological and coagulation parameters. The most common side-effect is disruption of the menstrual bleeding pattern; this is reported by two-thirds of the users in the first months and by one-third by the fifth year. Because it is the most disturbing side-effect for many users, counselling prior to insertion is of paramount importance. NORPLANT exerts varying degrees of gonadotrophin and ovarian inhibition, including anovulation and luteal insufficiency. Endometrial development is irregular and, irrespective of oestrogen levels, cervical mucus is thick and scanty at all times due to the strong antioestrogenic effect of LNg. Inhibition of sperm penetration fully accounts for the antifertility effect of NORPLANT in ovulatory cycles. The high contraceptive efficacy, lack of serious side-effects, reversibility and the convenience of long-term unattended use explain the high acceptability of NORPLANT.

Body Weight↗

PubMed2006

Ovarian cysts in users of Implanon and Jadelle subdermal contraceptive implants.

OBJECTIVE: To evaluate the prevalence of ovarian cysts in users of two contraceptive implants compared to users of intrauterine contraceptive (IUC). MATERIALS AND METHODS: A total of 344 women were enrolled at 3 months of use of the etonogestrel-releasing implant (Implanon), the levonorgestrel-releasing implant (Jadelle) or the TCu380A IUC. Bimanual pelvic examination and vaginal ultrasound were performed during routine 3-, 6- and 12-month visits of asymptomatic women. Women with ovarian cysts (or enlarged ovarian follicles > or = 25 mm) were assessed weekly until disappearance or reduction of the image [including estradiol (E2) and progesterone (P) measurement], and women with no ovarian enlargement underwent the same evaluation for the same period of time. RESULTS: Ovarian cysts were detected in 5.2%, 13.0% and 1.9% of users of Implanon, Jadelle and IUC, respectively, at 3 months. At 6 months of use, prevalence was 7.2%, 8.0% and 2.1%, whereas 12-month rates were 26.7%, 14.6% and 1.2% in the three groups, respectively. E2 levels were significantly higher among users with ovarian cysts than controls. The time until disappearance of the ovarian cyst was similar in all three groups. There were more cases of menorrhagia in users of implants who had ovarian cysts than in those with no ovarian enlargement. CONCLUSIONS: The finding of ovarian cysts or enlarged ovarian follicles during the first year of use of Implanon and Jadelle implants is common and transient and should not be interpreted as a pathologic ovarian cyst. No further medical interventions are necessary.

Adult↗

PubMed1988

Serum lipid profile in women using levonorgestrel contraceptive implant, Norplant-2.

Cholesterol content of major lipoprotein fractions along with total cholesterol (Tc) and triglyceride (Tg) were measured in 65 samples from 35 women using levonorgestrel contraceptive implant, Norplant-2 from the third month of implantation until the end of second year along with twenty-five healthy controls. There were significant decreases in all the fractional lipid values, Tc and Tg, up to the sixth month followed by a gradual rise of all lipid parameters except HDLc which remained much below the control level. Interestingly, VLDLc exhibited a significant rise at the end of the second year.

Adult↗

PubMed2002

Toxicology of progestogens of implantable contraceptives for women.

There are currently four progestogens used in implantable contraceptives marketed or tested in clinical trials: levonorgestrel in Norplant and Jadelle, etonogestrel (3-keto-desogestrel) in Implanon, nestorone in Elcometrine, and nomegestrol acetate in Uniplant and Surplant. Each progestogen was evaluated for hormonal activity and for safety in a wide variety of tests in vitro and in animals prior to their use in women. All four progestogens underwent pre-clinical testing that generally followed the format for animal testing of steroidal contraceptives published by the World Health Organization and the US Food and Drug Administration (FDA). Most of the progestogens have been tested for genotoxicity in bacterial and mammalian cultured cells and in rodents. All were tested for toxicity in short- and long-term toxicology studies in rodents and dogs or monkeys, and all were tested for their effects on reproduction and fetal development. In most cases, the progestogens were tested for carcinogenicity in two rodent species, rats and mice. Early clinical trials in small numbers of women provided additional safety data prior to the exposure of large numbers of women in Phase 3 clinical trials. The published data and data submitted to the FDA demonstrate that the implantable progestogens have no significant or unusual toxicities and have a similar safety profile to the progestogens found in the approved oral contraceptives.

Animals↗

PubMedDate not supplied

Repeat fertility and contraceptive implant use among Medicaid recipients in Colorado.

Late in 1991, Colorado's Medicaid program approved coverage for the hormonal contraceptive implant among Medicaid recipients. Subsequently, the Colorado Department of Public Health and Environment undertook an analysis of data supplied by the state's Medicaid program of the probability of repeat births among Medicaid recipients. According to life-table analysis of two cohorts of women in the database who had their first Medicaid-eligible birth in 1991 and 1992, the rate of repeat delivery within 24 months of the preceding birth fell from 14.1% among 11,554 women who first delivered in 1991 to 10.6% among 13,624 women who first delivered in 1992. The 25% decline in the rate of repeat births between the two cohorts was statistically significant. These rates were higher among Medicaid-eligible mothers who first gave birth as teenagers-22.3% in the 1991 cohort and 15.9% in the 1992 cohort. Among the 2,739 Medicaid-eligible women who delivered in 1992 and chose to use the implant within six months of delivery, the repeat delivery rate was just 2.5% within 24 months; this proportion was virtually the same among implant users in the 1992 cohort who first gave birth as teenagers (2.3%).

Adolescent↗

PubMedDate not supplied

Comparison of contraceptive implant adopters and pill users in a family planning clinic in Baltimore.

All 133 women who began using the Norplant contraceptive implant between August and December of 1991 at a Planned Parenthood clinic in Baltimore were compared with a sample of 112 women who obtained prescriptions for the pill at the same clinic during the same time period. A multivariate analysis found that women of Medicaid are significantly more likely than those who are self-paying to select the implant rather than the pill. Similarly, compared with women who have had no children, those who have had two or more are also significantly more likely to choose the implant. However, adolescents and women who have had an abortion are no more likely than other women to select the implant.

Adolescent↗

PubMedDate not supplied

Insertion and removal of Norplant contraceptive implants by physicians and nonphysicians in an Indonesian clinic.

This paper reports on a study in which the performances of physicians were compared to those of nonphysician health personnel in inserting and removing NORPLANT subdermal contraceptive implants. The study was conducted in Raden Saleh Clinic at the University of Indonesia, Jakarta, from September 1982 to August 1984. In a group of 828 women who accepted NORPLANT 285 insertions were performed by physicians and 543 by nonphysician health personnel. During the study period, 122 removals were performed (43 by physicians and 79 by nonphysicians). This small proportion of removals reflects the high continuation rate for NORPLANT. There was no significant difference between the two groups of acceptors regarding age, parity, education, or side effects. The average insertion times were 7.6 minutes for the physician group and 7.4 minutes for the nonphysician group (p greater than 0.1). The average removal times were 21.7 minutes for physicians and 21.8 minutes for nonphysicians (p greater than 0.9). Complications during and following insertion and removal were minimal for both groups, and no significant differences were found. It was concluded that nonphysician health personnel are qualified to administer the NORPLANT contraceptive implants.

Adult↗

PubMedDate not supplied

The availability and accessibility of the contraceptive implant from family planning agencies in the United States, 1991-1992.

During the first year and a half after the hormonal contraceptive implant became available in February 1991, an estimated 81,100 women obtained this method from family planning agencies in the United States. Nevertheless, according to a recent survey of family planning providers, implant availability through the family planning clinic system is still far from universal. By September 30, 1992, only 40% of all family planning agencies were offering implant services to their clients: That proportion ranged from 30% of health department family planning providers to 80% of Planned Parenthood affiliates. Some of the key reasons cited by agencies that do not yet provide implants include the special clinician training required to learn insertion and removal procedures, and the cost of the method. Furthermore, full accessibility of this method to low-income women attending family planning clinics has been limited primarily to those who receive Medicaid, which has paid for more than 60% of all hormonal implants inserted by family planning agencies.

Contraceptive Agents, Female↗

PubMed1994

Sphenoid wing meningioma progression after placement of a subcutaneous progesterone agonist contraceptive implant.

A causal relationship between sex steroids and meningioma proliferation has long been suspected. We report a case of the clinical progression of a sphenoid wing meningioma after the placement of Norplant, a subcutaneous contraceptive implant containing levonorgestrel, a progesterone agonist. Although not proof of causation, this observation lends further credence to the importance of progesterone receptors in the growth and possible treatment of meningiomas.

Adult↗

PubMed1993

Release characteristics, ovarian activity and menstrual bleeding pattern with a single contraceptive implant releasing 3-ketodesogestrel.

The properties of a single contraceptive subdermal implant releasing 3-ketodesogestrel were assessed in fifteen women over twelve months. Serum levels of 3-ketodesogestrel were monitored regularly following insertion and after removal. The mean serum level of 3-ketodesogestrel was 245 pg/ml after 72 h (steady state) and 176 pg/ml after twelve months. All volunteers demonstrated ovulation inhibition throughout the study. Transient oestradiol peaks occurred during the study. No luteal activity was noted. The cervical mucus was rapidly rendered hostile to sperm migration. Two women withdrew from the study during the first six months for medical reasons. Both volunteers cited bleeding irregularity as the main cause, one complaining of oligomenorrhoea, the other of prolonged bleeding/spotting episodes. A small but significant increase in weight was noted during the study period.

Adolescent↗

PubMed2006

Endometrial histology, microvascular density and caliber, and matrix metalloproteinase-3 in users of the Nestorone-releasing contraceptive implant with and without endometrial breakthrough bleeding.

OBJECTIVE: This descriptive study evaluated endometrial histology, microvascular density and caliber, and quantification of matrix metalloproteinase (MMP-3) expression in long-term users of the Nestorone (NES)-releasing implant who presented or not endometrial breakthrough bleeding (BTB). METHODS: Endometrial biopsies were obtained from 32 healthy women with unpredictable BTB. The quantitative analysis was performed only in 20 samples. RESULTS: The mean duration of use of the implant among the 14 women with BTB was 19.6+/-1.0 months, and the other six women had used the implant for 17.7+/-2.3 months (mean+/-S.E.M.). Histological analysis of the endometrial tissue showed a predominance of progestogenic pattern followed by atrophic and proliferative endometrium in both groups. Mucosal breakdown and glandular pseudostratification were observed in half of the cases. Endometrial vascular density was 73.1+/-10.0 and 57.5+/-24.1 vessels/mm(2), and maximum vessel diameter was 923.3+/-86.0 and 1038.0+/-404 microm (mean+/-S.E.M.) in the group with and without BTB, respectively, without significance, and the rate of cells expressing MMP-3x1000 counted stromal cells was 155.8+/-24.8 and 127.0+/-19.0 (mean+/-S.E.M.) in both groups, respectively, without significance. CONCLUSIONS: This study provides information about some endometrial aspects of women using NES in contraceptive implants. In addition, the endometrium was similar during long-term use of NES-releasing contraceptive implants in women with and without endometrial bleeding.

Adult↗