Depot progestins as injectables, implantables or vaginal rings are suitable for contraception in those female patients, in which risk factors (e.g. cardiovascular risk) exclude the use of estrogen-progestin mixtures. In this paper the mode of action, indications, contraindications, advantages and disadvantages of the various methods using depot-progestins are discussed. Injectables contain either medroxyprogesterone acetate or norethistronenantate; both steroids are released slowly within a limited time interval (2 to 4 months) out of a depot. The major effect is a change of the cervical mucus. Side-effects are disturbances of the menstrual cycle (e.g. breakthrough bleedings) as well as an amenorrhea after frequent use (up to 50% of all cases). The subdermal implantables (Norplant 2 or 5) release levonorgestrel out of a depot over a time period of at least 5 years. Steroid plasma levels are lower than in those patients using a progestin-only pill. Side-effects of implantables are disturbances of the menstrual cycle (e.g. breakthrough bleeding); in patients who desire to conceive a child or suffer from undesirable side-effects the implantables can be removed at every time. The progestin releasing vaginal rings are in a stage of controlled clinical trials. The advantages depend on ethe easy mode of administration (implantation or removal). Side-effects are also breakthrough bleedings.

OBJECTIVE

Menstrual irregularity is the main cause of termination of Norplant use; a study of its safety and level of acceptance is needed.

METHODS

A cohort study using medical records of Dr Kariadi Hospital, Semarang, Indonesia and interviews between Norplant and IUD users who had in 1993 been followed-up for 5 years. Expulsion rate, removal rate, level of acceptance and satisfaction were examined.

RESULTS

From 170 Norplant and 168 IUD acceptors, the net cumulative pregnancy rates by month 36 of the Norplant and the IUD groups were 0.0% and 1.19%, respectively (p>> 0.05). The net cumulative expulsion rates were 0.61% and 1.32% (p>> 0.05). The net cumulative rates of removal for medical reasons were 2.37% and 1.97% (p>> 0.05). The net cumulative removal rates for non-medical reasons were 1.80% and 10.38% (p < 0.001); the net cumulative continuation rates were 95.29% and 85.60% (p < 0.002). The net cumulative acceptance rates were 97.04% and 93.83% (p>> 0.05). The Norplant users experienced less menstrual and inter-menstrual bleeding and more amenorrhea than the IUD group. The psychological satisfaction scores among the Norplant and IUD users were high (p>> 0.05). The Norplant contraceptive is well accepted.

CONCLUSIONS

The findings could be very useful for further steps in promoting Norplant as a contraceptive that is long-acting, with good efficacy, acceptance, and safety.

OBJECTIVE

To evaluate the possible role of tamoxifen (selective estrogen receptor modulators, SERM) in treating bleeding irregularities associated with Norplant contraceptive use.

METHODS

Randomized clinical trial including 100 Norplant users complaining of vaginal bleeding irregularities. The trial was conducted in the Family Planning Clinic of Assiut University Hospital. Women were assigned at random to receive tamoxifen tablets (10 mg) twice daily for 10 days or similar placebo. Women were followed-up for 3 months. The end points were percentage of women who stopped bleeding during treatment, bleeding/spotting days during the period of follow-up, effect of treatment on their lifestyle, and side effects and discontinuation of contraception.

RESULTS

There was good compliance with treatment. At the end of treatment, a significantly higher percentage of tamoxifen users stopped bleeding in comparison to the control group (88% vs. 68%, respectively; p=.016). Women who used tamoxifen had significantly less bleeding and/or spotting days than women who used placebo, during the first and second months. During the third month, there were no significant differences between the two groups. Women who used tamoxifen reported improvement in performing household activities, religious duties and in sexual life, during the first 2 months. In the third month, there were no differences between the two groups. There were no significant differences between tamoxifen and placebo groups in reporting side effects. In the group who used tamoxifen, two women discontinued Norplant use because of bleeding vs. nine women in the placebo group.

CONCLUSIONS

Tamoxifen use at a dose of 10 mg twice daily orally, for 10 days, has a beneficial effect on vaginal bleeding associated with Norplant use. In addition, the bleeding pattern was better in women who used tamoxifen for the following 2 months after treatment. However, these results have to be confirmed in a larger trial before advocating this line of treatment.

This study was a consecutive-case series of 138 Latinas (age 16 to 36) who received levonorgestrel implants (Norplant) in a community health center between September 1, 1992, and December 31, 1994, and were observed through September 30, 1997. Continuation rate at one year was 70 percent, and 43, 28, and 22 percent at two, three, and four years, respectively. Average observation time was 32 months. Most frequent reasons for removal were excessive bleeding (34 percent), weight gain (26 percent), hair loss (16 percent), amenorrhea (13 percent), desire for pregnancy (11 percent), and headaches (9 percent). Five women discontinued due to fear of ill effects, four to undergo sterilization. No pregnancies occurred while using the method. Norplant is an effective contraceptive for inner-city Latinas; removal rate was higher than in previous reports. Side effects or fear of side effects led to removal in more than half the patients by two years' use.

OBJECTIVE

Contraceptive-induced vaginal bleeding changes may be an undesired side effect, or a welcome opportunity to alter menstrual patterns. In Europe and the US, such changes are increasingly accepted; this study explores the perceptions of women around the globe.

METHODS

Norplant users from five countries (Chile, China, the Dominican Republic, Indonesia and Tunisia; N = 486) were surveyed at entry into a contraceptive clinical trial regarding preferred frequency of menstruation, menses-associated symptoms, and activities during menses.

RESULTS

Most women preferred once-monthly menstruation (81%); women in Chile, younger women, women neither married nor cohabitating, Christian women, and women experienced with hormonal contraception were more likely to accept alternative bleeding patterns. Women in Tunisia and Chile reported more symptoms associated with menses, while women in Beijing reported very few; decreased energy (32%), headaches (26%), abdominal pain (23%) and depression (22%) were most common. Avoidance of activities during menses such as physical work, sports, praying and entering religious sites, was closely tied to study centre. Across all sites, women (90%) avoided sexual intercourse during menses.

CONCLUSIONS

Despite growing acceptance of altering bleeding patterns, women in this study preferred monthly vaginal bleeding. Understanding sociocultural contexts and individual preferences is important when addressing this issue with women from diverse backgrounds.

A prospective study of the Norplant-2 contraceptive subdermal implant system was conducted in Bangkok, Thailand. The objective of the study was to evaluate the efficacy, adverse effects, and overall acceptability of Norplant-2 implants. A total of 140 women were enrolled in a 3-year clinical trial. The mean age was 29 years. Of all the acceptors, 70% had completed primary school. The continuation rates at years 1, 2, and 3 were, respectively, 94%, 89%, and 83%. No accidental pregnancies occurred throughout the 3 years of use in this study. Personal reasons were the leading cause for termination of Norplant-2 implant use. The 3-year cumulative termination rate for personal reasons was 7.2%. These personal reasons were divorce, husband having vasectomy, and moving away from the study area. The other leading cause for termination was medical reasons; acne, headache, and pain at the implant site were the complaints. The termination rate for medical reasons in year 3 of the study was 4.6%. Prolonged menstrual flow was the other main reason for termination. The 3-year cumulative termination rate for menstrual irregularities was 3.8%. In this study, the cumulative termination for planned pregnancy at the end of the year 3 was only 1.6%. The incidence of difficult removals was 8%. Breakage of the rods on removal was encountered in the majority of these cases. The study findings presented suggest that the Norplant-2 implants are highly effective with high continuation rates. The Norplant-2 system could become another choice of long acting reversible contraception for Thai women.

OBJECTIVE

Norplant is a long lasting contraceptive method which protect again pregnancy for five years. We studied the side effects and the variations related to weight and blood pressure.

METHODS

The study was carried out in three family planning clinics in Dakar with 450 women who have had their implants for at least six months. Data collection was based on patient interviews and review of medical files.

RESULTS

The side effects reported were mainly menstrual problems with 54.7% of the women reporting menstrual spotting. The other non-menstruel side effects were headaches (64.2%) and dizziness (59.1%). The side effects at the insertion site were pruritus (16%) and pain (3.1%). Regarding weight and blood pressure, an increase in weight was observed up to three years of Norplant use and a decrease to the initial weight was seen during the fifth year of use. No variation was noted regarding blood pressure.

CONCLUSIONS

Norplant is a contraceptive method widely used in Senegal. Most of the side effects involve menstrual problems. A slight increase of weight was observed in general with no variation in blood pressure.

OBJECTIVE

To determine the uptake, acceptability and continuation rates of a new contraceptive implant, Norplant.

METHODS

Review of case notes of all acceptors during the two years following the introduction of the implant.

METHODS

A large family planning clinic in Edinburgh.

METHODS

All women choosing Norplant.

RESULTS

508 women chose Norplant, many as an alternative to sterilisation or because they had experienced problems with other methods of contraception. 9% of women were lost to follow-up. Of the remainder continuation rates were 84% at one year and 80% after 18 months of use. 43% of women gave bleeding problems as the reason for removal. However the combination of weight gain, mood swings, depression and headache was frequently reported as unwanted side effects by women seeking removal. No major problems were experienced with either insertion or removal of Norplant.

CONCLUSIONS

Norplant is an effective method of contraception which many women find attractive. The incidence of erratic bleeding is high but many women tolerate this problem because the method is easy to use and lasts five years. Careful counselling is essential for high continuation rates.

OBJECTIVE

To assess the efficacy, safety of Norplant implants used by Chinese women.

METHODS

In a prospective, multicenter clinical trial, 10,718 women receiving Norplant implants were monitored annually through 5 years and part of women continuously used the implants up to 7 years.

RESULTS

The five-year pregnancy rate was 0.63/100 users. 7,554 women completed 5 years, 3,622 women completed 6 years and 2,433 women completed 7 years. The annual pregnancy rates were 0.40/100 users in both year 6 and year 7. The pregnancy rates increased with weight (P < 0.05) and decreased with age. The menstrual disturbances were common, also the main reason for discontinuation. Headache, dizziness and weight gain led to termination more frequently than did other adverse events apart from menstrual disturbances. The 5-year continuation rate was 72.1/100 users. Among aged>> 30 and weight < 60 kg, the implants may be used for 7 years.

CONCLUSIONS

It's proved that the Norplant implants is a highly effective, long acting, safe, simple and reversible contraceptive method, and it is acceptable in Chinese women.

Norplant has been the focus of controversy in Iran because of its relatively high premature removal rate. This study assessed the reasons for Norplant removal and its 5-year continuation rate to clarify the determining factors on elimination of this method. Subjects were identified via a retrospective chart review of Norplant users in Shiraz, Iran who were followed for 5 years. The mean age and weight of acceptors were 23.6 +/- 4.1 years and 54.4 +/- 8.5 kg, respectively. The most common reasons for removal were menstrual disturbances and personal reasons (each 41%). The 5-year continuation rate was 45%; on average, Norplant capsules were in place for 4.1 +/- 0.09 years. Norplant has been shown to be an acceptable option in other Muslim countries, so the relatively high rate of removal in Iran could not be attributed to the Norplant itself, but is probably linked to other factors that are in need of improvement.

This study assesses potential demand for Norplant implants using data from a population-based survey conducted in rural Sri Lanka. Overall, 35% of currently married non-sterilized women of childbearing age expressed interest in using the implants, 52% did not want to use the method, and 13% were unsure about using it. The demand was substantially higher (44% vs 28%) among younger age groups (less than 30 years) than among older age groups (30-44). The results showed that life-cycle variables (age, parity and marital duration) and fertility preference variables (desire for another child and desired birth-interval) were generally more important than socioeconomic variables in determining variations in potential demand for Norplant in Sri Lanka. Desired birth spacing was found to be a powerful indicator of the potential demand. The majority (85%) of respondents interested in using Norplant were also willing to absorb at least some of the cost of the implants. Among older age groups, those who were using modern temporary methods of contraception either exclusively or in combination with traditional methods had a higher demand for Norplant than non-users or exclusive users of traditional methods. For the younger women, however, potential demand did not vary significantly according to whether they were currently using a method or the type of method used.

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.

To improve counselling information to Nigerian family planning clients, we compared non-menstrual events reported by 248 Norplant users and 214 Uniplant users. Women using Norplant were significantly older and of higher parity and greater contraceptive experience than Uniplant users. Other admission characteristics of the two groups were similar. The total women-months of use of Norplant was 2,946 (mean 11.9 +/- 0.6 SE) months while that for Uniplant was 2,315 (mean 10.8 +/- 0.2 SE) months. About 36% of Norplant users and 15% of Uniplant users reported non-menstrual adverse events, the commonest ones being pain/itching at the insertion site, unexplained low abdominal pains and clinically diagnosed pelvic inflammatory disease (PID). The numbers of women reporting drug-related adverse events were 61 (24.6%) and 23 (10.8%), respectively, among Norplant and Uniplant users. Drug-related serious adverse events were reported by 3 (1.2%) Norplant users and 5 (2%) Uniplant users. The adverse events leading to Uniplant removal were severe urticaria, breast lumps, pruritus vulvae, headache with raised blood pressure, adnexal pains and ovarian cysts, and static weight while those leading to Norplant removal were breast lump and headache with raised blood pressure. Weight gain was reported by only 7 (3%) of Norplant users. Although of no serious clinical consequences, drug-related adverse events should be added to the counselling information to prospective users.

The levonorgestrel implant (Norplant System; Wyeth-Ayerst Laboratories, Philadelphia, Pa.) is a highly effective and desirable form of contraception for the adolescent population today. Not originally marketed toward this group of young women, it has become a very popular form of birth control for this age group. Even though common side effects are frequently experienced with the use of the Norplant System, timely and reassuring counseling from nurse practitioners is very effective in allaying fears and dissatisfaction. At the Pediatric Clinic for Denton County, Texas, nearly one half of all teenagers enrolled in the Teen Pregnancy Program in 1992 chose the Norplant System as their method of birth control, with very successful results.

OBJECTIVE

This study was designed to determine the factors associated with Norplant choice for postpartum teens.

METHODS

A total of 151 teenagers, ages 12-20 years, who delivered at the Medical Center of Delaware from July to December 1992, were offered insertion of Norplant within 48 h postpartum. A structured interview was conducted in the postpartum period after nondirective counseling sessions including a physical demonstration using anatomical models of various contraceptive methods. Student's t-tests, chi-square, and multivariate analyses were used.

RESULTS

Eighty-six teenagers were African-American (mean age = 17.3 +/- 1.9 years) and 65 non-Hispanic white (NHW) (mean age = 18.3 +/- 1.5 years). The NHW teenagers were older (p < 0.001); the African-American teenagers were more likely to have Medicaid (49% vs. 14%; p < 0.001) and to have one or more friends who use Norplant (62% vs. 34%; p < 0.001). In multivariate analyses, NHW teenagers were more likely to choose Norplant if they had discussed their choice with a parent or guardian [adjusted odds ratio (AOR) = 14.6, 95% confidence interval (CI), 2.12-100.57]; had Medicaid funding (AOR = 12.1; 95% (CI), 10.6-91.34); and had any friends who used Norplant (AOR = 6.3; 95% (CI), 1.38-28.40). However, for African-American teenagers, the strongest predictor for choice of Norplant was number of prior children delivered. After two deliveries, there was a better than four-fold likelihood (AOR = 4.8; 95% (CI), 1.47-15.94) that African-American teenagers would choose Norplant. For the African-American teenagers, parental discussion, Medicaid status, and friends' use of Norplant were not as important as family size, but far greater percentages of the African-American teenagers had access to Medicaid funding and peers who used Norplant.

CONCLUSIONS

NHW and African-American teenagers choose Norplant for different reasons. Lack of funding may have been a barrier to choosing Norplant. Discussions with parents and friends have a positive influence on choosing Norplant for NHW teenagers. African-American teenagers were more likely than NHW to have Medicaid coverage, and more frequently choose Norplant if the current birth was their third child.

The Association for Voluntary Surgical Contraception (AVSC) does not expect dramatic advances in female sterilization during the decade. Minilaparotomy and laparoscopy will endure as the standard surgical approaches, but programs will continue to shift toward the use of local anesthesia for these procedures because of greater safety and lower costs. No-scalpel vasectomy demonstrated by AVSC to be popular, effective, and safe holds greater potential for expanding the vast, and largely ignored, male market. The injection methods of vasectomy now being tested in China and elsewhere may make male sterilization even more acceptable. Markets for IUDs, implants, and injectables will continue to expand as more clients seek safe and effective long term contraception, and as national family planning programs (particularly in Asia) realize the ethical and programmatic importance of offering choices. Norplant is expensive and requires a skilled network of providers to both insert and remove the implants. For these reasons, AVSC expects Norplant to remain a niche method, mostly for urban clients who are not interested in sterilization or who are ill-suited for IUDs or injectables. Injectables, already popular in many parts of the world, will become increasingly available and used now that the US food and Drug Administration has approved Depo-Provera. New types of injectables, currently being developed, will be brought to market. The potential for IUDs is vast, particularly the low-cost, highly-effective Copper T 380A, which is expected to be approved as a 10-year method. However, poor quality service delivery and the high prevalence of sexually transmitted diseases could limit the potential of this method.

The effects of low-estrogen and progestogen-only contraceptives on blood pressure changes were investigated on 238 women taking 35 micrograms EE OC, 267 using Norplant implants and 259 adopting IUD. The mean increases in diastolic pressure at 12, 24, 36 and 48 weeks among pill users were significantly (p < 0.05) higher than those among IUD users by 1.8, 2.1, 2.3 and 1.9 mm Hg, respectively; the increases in systolic pressure were higher but not significant (p>> 0.05) by 1.3, 1.7, 1.5 and 1.3 mm Hg. Neither systolic nor diastolic blood pressure was affected by use of Norplant implants. Regression analysis, including interaction terms, showed that women's age, obesity and family history of hypertension were associated with an increase of blood pressure during follow-up and were independent of contraceptive use and vice versa. After adjustment of some potential confounding variables, pill users showed a 1.0 mm Hg rise in diastolic pressure, which is statistically significant but clinically unimportant.

A clinical trial of levonorgestrel-releasing Norplant implants used for contraception was undertaken in two cities in Colombia. Through two years in which 389 women had accumulated 594 years of use, there were no pregnancies. In a comparison group of copper intrauterine device acceptors, the one-year pregnancy rate was 1.1 per 100. Menstrual disturbances associated with progestin-only administration were the principal side-effects, and the major reason for cessation of use. Continuation among users of the implants was at the same or at a higher rate than observed among users of the intrauterine device. Advantages and disadvantages of alternate sites for implant placement are discussed.

The NORPLANT system is the first new methodology to be introduced in the past 30 years in the field of contraception. It is a subdermal, reversible system of Silastic capsules containing the synthetic progestin levonorgestrel. Advantages and disadvantages are discussed. Compliance-free use and high effectiveness are its main characteristics.

Norplant is a new method of birth control recently approved for use in the United States. It consists of flexible Silastic capsules filled with levonorgestrel, which are inserted subdermally on the inside of the upper arm. Norplant provides a near steady-state level of levonorgestrel for five years. It has been used in many European, South American and Asian countries, and in clinical studies in the United States. Norplant has an excellent continuation rate by users, and it is highly effective. It causes minimal adverse effects other than irregular menstrual patterns.

A modified mammography technique for localization of concealed Norplant implants and Norplant fragments was applied to four patients, ages 18, 35, 22, and 25. A dedicated mammography unit and mammography film screen system affording high resolution and high contrast was applied under the same conditions to each patient. 26 kilovoltage peak (KVp) was used, ranging from 60 to 150 milliamperes. Using both the automatic exposure control and manual techniques, specific milliampere range depended on the specific case. The technique proved successful, as concealed Norplant capsules were exquisitely visualized by films obtained with a Siemens Mammomat 3000. Applying the same modified technique, precise location of the Norplant implants was determined using a fenestrated compression plate with an alphanumeric grid in a manner similar to hookwire localization of breast lesions under mammographic guidance. The capsules were then safely retrieved. We conclude that this modified technique may provide practitioners with valuable assistance in the exact localization of the Norplant capsule(s) or fragments, thereby facilitating their removal. Application of a modified mammography technique reveals precise localization of concealed Norplant capsules facilitating their removal.