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PubMed1992

Carbohydrate metabolism before and after Norplant removal.

Changes in carbohydrate metabolism, measured by oral glucose tolerance test, were studied in Norplant users before and after removal. The mean area under the glucose curve rose from 24.7 min mmol/L before Norplant insertion to 35.1 min mmol/L before removal and decreased to 26.1 min mmol/L four weeks after Norplant removal. The areas before insertion and after removal were not statistically different (95% confidence interval -3.3 to 0.56, P = 0.16). The mean areas under the insulin curves before insertion (53.14 min uU/L) and after removal (59.46 min uU/L), however, were significantly different (95% confidence interval -7.64 to -5.0, P less than 0.0001). We conclude that changes in carbohydrate metabolism induced by Norplant are reversible once the implants are removed. While the changes in glucose induced by Norplant returned to pre-insertion levels within 4 weeks after removal, insulin changes were slower to return to pre-insertion values.

Adult↗
PubMed1989

Two-year follow-up of changes in clinical chemistry in Singaporean Norplant acceptors: metabolic changes.

In this longitudinal study involving 100 Singaporean acceptors, the effects of Norplant on metabolic function was evaluated. With respect to liver function, the results at the end of two years still indicate the presence of possible hepatocellular dysfunction. Despite a 4.5% decrease in serum bilirubin during the second year, the mean serum bilirubin still remained significantly raised (p less than 0.001). Furthermore there was a significant fall in total proteins and globulin during the period under review (p less than 0.001). However mean levels of all three parameters remained within the normal clinical range. As regards lipid metabolism, the total triglycerides and total cholesterol still remained significantly decreased at the end of two years (p less than 0.001). The LDL-cholesterol, which was significantly decreased at the end of one year, increased by 2.2% during the second year. However, this rise in LDL-cholesterol was not significant and was still below the preinsertion level. The HDL-cholesterol levels returned to their preinsertion levels after a significant increase in the first year. The HDL-cholesterol/Total cholesterol - HDL-cholesterol ratio returned to its preinsertion value at the end of two years while the LDL-cholesterol/HDL-cholesterol ratio was still significantly lower than the preinsertion ratio (p less than 0.05). As we have not incorporated a simultaneous non-steroid treated control group, the observed changes in lipoprotein lipids could be attributed to extraneous factors such as diet, exercise or other environmental changes.(ABSTRACT TRUNCATED AT 250 WORDS)

Bilirubin↗
PubMed1989

Effect of Norplant contraceptive use on hemoglobin, packed cell volume and menstrual bleeding patterns.

A study was conducted to evaluate the effect of NORPLANT use on hemoglobin levels (HB), packed cell volume (PCV) and menstrual bleeding patterns. NORPLANT insertions were performed on 50 healthy volunteers in Ilorin, Nigeria, between January-March 1986. Whole blood samples were collected at admission, 6-month and 12-month follow-up visits, and each acceptor was asked to keep a daily bleeding calendar. Mean age of the acceptors was 32.8 years with a mean parity of 5.3 live births. Almost 50% of the acceptors indicated that they did not want any more children. After 12 month's follow-up, there were a total of three discontinuations, two for excessive menstrual bleeding and one due to husband's objection. Mean HB and PCV values remained relatively unchanged from admission to 12 months. Nearly 50% of the women experienced at least one episode of 8 or more days of continuous bleeding during the first six months of use, and about 20% reported amenorrhea of 90 or more days. Despite the incidence of menstrual bleeding irregularities, acceptability of the NORPLANT method was high as indicated by a 1-year continuation rate of 93.7 per 100 users. Clinically more important was the finding that despite a high proportion of women reporting menstrual pattern changes, HB and PCV levels remained unchanged.

Adult↗
PubMed1979

First year clinical experience with six levonorgestrel rods as subdermal contraception.

Previous clinical experience with six levonorgestrel subdermal capsules showed a very good contraceptive effectiveness and continuation rate, but with a high proportion of bleeding disturbances, particularly of increased bleeding. It was hypothesized that bleeding could be reduced by higher plasma levels of the steroid, using subdermal rods instead of capsules, as rods have been shown to have a release rate 3 or 4 times that of the capsules. Fifty volunteers were enrolled in a study of the clinical performance of 6 subdermal levonorgestrel rods. Results were compared with a previous experience with 100 volunteers who wore 6 levonorgestrel capsules for a year in the same clinic. Requirement for volunteers to enter the study were the same for capsules and rods. The proportion of women wearing 6 subdermal rods who had increased bleeding was about one half as for the women using 6 levonorgestrel capsules. On the other hand, women using rods had about twice the incidence of amenhorrea, and about four times more hypomenorrhea (4 days or less of bleeding in a 90-day period). There were no pregnancies among the rod users and the discontinuation rate for medical reasons was not higher than for capsule users in the same clinic.

Adolescent↗
PubMed1984

Long-term reversible contraception with levonorgestrel-releasing Silastic rods.

Subcutaneously placed Silastic capsules containing levonorgestrel are effective for 5 years and have a higher continuation rate than other methods of reversible contraception. Six 3 cm capsules are required to achieve satisfactory circulating levels of levonorgestrel. Two 4 cm covered Silastic rods containing levonorgestrel, which are easier to manufacture, insert, and remove than the capsules, produce similar in vitro release rates. This study compared clinical and metabolic effects as well as bleeding patterns in 23 women using either six capsules (n = 11) or two covered rods (n = 12). Serum levels of levonorgestrel, lipids, and lipoproteins as well as frequency of elevated progesterone levels were compared in serum samples obtained before treatment and 1, 6, 12, 18, and 24 months after insertion with the two systems. While bleeding patterns were similar for users of the two systems, rod users had slightly higher serum levels of levonorgestrel and a lower incidence of cycles with elevated progesterone levels. Therefore, rods could replace capsules as a long-term, reversible contraceptive method.

Adolescent↗
PubMed1984

A two-year experience with Norplant implants in Assiut, Egypt.

This report describes the two-year experience of 250 acceptors of NORPLANT implants and 100 TCu-380-Ag IUD acceptors in Assiut, Egypt. The two-year net continuation rate was 67.9 per 100 for implant users and 52.3 per 100 for IUD users. The most important cause for NORPLANT removal was the disruption of menstrual rhythm. However, by the end of the second year, three-quarters of NORPLANT users had monthly menstrual periods and about 60 percent described the amount of blood loss as average, 15 percent as decreased, 15 percent as increased and 10 percent as variable. About 88 percent of the NORPLANT acceptors rated their experience with the contraceptive as good or excellent.

Adult↗
PubMed1987

Norplant contraceptive implants: rods versus capsules.

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.

Adolescent↗
PubMed1988

The effects of Norplant-2 rods on clinical chemistry in Singaporean acceptors after 1 year of use: metabolic changes.

In this longitudinal study involving 100 Singaporean acceptors, the effects of Norplant-2 rods on metabolic function was evaluated. With respect to liver function, the results indicate possible hepatocellular dysfunction. There was a significant rise in mean serum bilirubin from 0.54 mg/dl to 0.85 mg/dl after 12 months of use (p less than 0.001). Furthermore, there was also a significant fall in total proteins from 7.37 gm/dl to 7.12 gm/dl (p less than 0.001) and serum globulin from 3.18 gm/dl to 2.84 gm/dl (p less than 0.001). As regards lipid metabolism, we have demonstrated significant decreases in mean serum triglycerides (1.04 mmol/l to 0.83 mmol/l), p less than 0.001; total cholesterol (5.04 mmol/l to 4.64 mmol/l), p less than 0.001; and LDL-cholesterol (3.36 mmol/l to 3.10 mmol/l), p less than 0.001 after one year of use. There was a small fall in the HDL-cholesterol (1.21 mmol/l to 1.16 mmol/l) after 12 months of use; this fall was not significant. Despite this, there was a rise in the HDL-cholesterol/Total cholesterol - HDL-cholesterol ratio (0.258 cf 0.244; p less than 0.05) after 1 year of use. As we have not incorporated a simultaneous non-pill treated control group, the observed changes in lipoprotein lipids could be attributed to extraneous factors such as diet, exercise or other environmental changes. Nevertheless, the findings, though speculative, indicate Norplant-2 use to be non-contributory to cardiovascular risk and indeed it may be a protective factor against such risks in this population. The use of Norplant-2 rods was not associated with any significant effect on glucose tolerance after 12 months of use.

Adult↗
PubMed1989

Bleeding patterns and acceptability among Norplant users in two Asian countries.

Changes in menstrual bleeding patterns are the most frequent reason for discontinuing NORPLANT during the first year of use. Although NORPLANT is used by more women in Asia than in any other region, the changes that occur among these women are not well documented. In pre-introductory clinical trials of NORPLANT in the Philippines and Sri Lanka, 175 women were enrolled with greater than 95% continuing the method after one year. Daily menstrual bleeding calendars were kept by 94% of subjects for nine months and by 66% for one year. In contrast to findings in previous studies which showed that approximately 60% of NORPLANT users had bleeding disruptions in the first year of use, almost all of these women experienced bleeding disruptions. In a one-year study of menstrual pattern changes, increased bleeding was found to occur with the same frequency as reduced bleeding. However, the changes experienced by the Asian women tended to be decreases, rather than increases, in menstrual bleeding.

Adult↗
PubMed1981

Menstrual blood loss with contraceptive subdermal levonorgestrel implants.

Six Silastic capsules each containing 30 mg of levonorgestrel were inserted subcutaneously in the left forearms of 13 volunteer women for contraceptive purposes. Quantitative determinations of menstrual blood loss were performed during a control cycle and during a 1-month period at the 1st, 6th, and 12th months of treatment. Days on which bleeding and spotting occurred were recorded and hemoglobin concentrations were determined. No changes were found in the amount of menstrual blood loss between the control cycles and the treatment cycles. The mean number of bleeding days during each of the three recorded treatment periods was significantly greater than that in the control cycles. No changes in hemoglobin concentration were found. None of the patients became pregnant during the study.

Adult↗
PubMed1991

Norplant.

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Drug Implants↗
PubMedDate not supplied

Characteristics and attitudes of early contraceptive implant acceptors in Texas.

In 1991, shortly after Norplant became available in the United States, 678 women who had received the implant from 17 providers in Texas were surveyed. Forty-five percent of these women were under 21 years old. The majority (56%) had tried the implant because they were dissatisfied with their previous contraceptive method. Forty-four percent of the sample indicated that the implant was one of the first contraceptive methods they had used and that they had only recently decided to prevent unplanned pregnancy. The average number of children per woman was 1.2, and one-third of the sample had had at least one abortion. While 37% of the women said they wanted no more children, 63% said they were using the implant as a spacing method. The reasons for choosing the implant and concerns about it varied according to the user's age, educational level and race or ethnic group.

Adolescent↗
PubMed1990

[Norplant].

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Adult↗
PubMedDate not supplied

Acceptance and perceptions of NORPLANT among users in San Francisco, USA.

Two hundred and five women participating in a five-year clinical trial of NORPLANT and NORPLANT-2 were interviewed about their contraceptive and reproductive history, sources of information and knowledge of NORPLANT, experiences using the method, and the impressions of friends and family about the method. The most common reasons for trying the implants were dissatisfaction with other methods and perceptions about NORPLANT's ease of use. Forty-one percent of acceptors had anxiety prior to insertion; 49 percent of these feared pain, but only 5 percent said that they actually experienced significant pain. Women also feared implant removal, but their fear did not influence their decision to continue or discontinue use, and 74 percent reported little or no pain at removal. Most of the women were pleased with NORPLANT, although 95 percent reported side effects, with 82 percent reporting changes in menstruation. More than one-half of those women who discontinued reported that they would use the implants again. Seventy-four percent of the current users interviewed said they would like to use the implants in the future. For the women enrolled in the clinical trial, NORPLANT appeared to be a highly acceptable method of contraception, despite the frequent occurrence of bothersome side effects.

Adult↗
PubMedDate not supplied

International experience with NORPLANT and NORPLANT-2 contraceptives.

Experience encompassing more than 20,000 woman-years of use of NORPLANT capsules and 6,000 woman-years of trials of NORPLANT-2 rods is reviewed. Implant contraception repeatedly has been associated with low pregnancy rates and high continuation rates through five full years of use. Weight has proved to be a factor related to effectiveness. Women weighing less than 50 kg experienced cumulative five-year pregnancy rates well below 1 per 100, whereas the overall cumulative rate has been 3.5 per 100. Medical events reported during use that have led to discontinuation are analyzed from four large data sets.

Body Weight↗