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Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study.

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.

Adolescent↗

Cytopathological changes in human cervix and endometrium following prolonged retention of copper-bearing intrauterine contraceptive devices.

Since 1971, cytological evaluation of cervical smears and endometrial aspirates was carried out in 604 women wearing CuT200 intrauterine contraceptive devices (IUDs) for periods ranging from 6 mo to 15 yr. No cases of cervical neoplasia or endometrial carcinoma were encountered, even after continuous use of the device for 15 years. Dysplastic cervical smears were, however, found in 45 postinsertional smears, and endometrial hyperplasia was detected in seven aspirates; in no cases was the dysplasia or hyperplasia higher than of moderate degree. Thirty-nine of the 45 women with postinsertional dysplastic smears were followed for 3-4 yr; in no case did the lesion progress to a higher grade or to frank malignancy. However, persistence and recurrence of dysplasia were seen in 10 women, necessitating removal of the IUDs. The incidence of cervical dysplasia and endometrial hyperplasia was found to be much higher when the IUDs had been changed than when the original devices were worn continuously. The rate of removal of IUDs because of persistent or recurring dysplasia was also much higher in the former group. Since no pregnancies were reported in any of the women wearing the original device for as long as 15 yr, we do not advocate the practice of changing the device at the end of 3 yr for maintaining contraceptive efficacy as recommended by the manufacturers; instead, we recommend the uninterrupted retention of the original device for periods not longer than 5 yr in view of occurrence of endometrial hyperplasia in two 6-yr wearers.

Adult↗

Postpartum contraceptive use among adolescent mothers.

OBJECTIVE: To compare the incidence of repeat pregnancy and method continuation rate at 12 months postpartum in young women who chose either depot medroxyprogesterone acetate or oral contraceptives (OCs) as contraception. METHODS: We conducted a prospective cohort study of 122 postpartum women younger than 18 years of age who delivered between January 8, 1997 and December 31, 1997. Patients choosing depot medroxyprogesterone acetate (n = 76) and OCs (n = 46) were accrued for 12 months and were followed-up for a minimum of 12 months. Main outcome measures were median contraceptive method continuation and the incidence of repeat pregnancy at 12 months postpartum. RESULTS: There was no difference in mean age at delivery (P =.47), parity (P =.84), or gravidity (P =.78) between depot medroxyprogesterone acetate and OC users. At 12 months postpartum, 27.4% of OC users and 55.3% of depot medroxyprogesterone acetate users were still using contraception. Median time to contraceptive discontinuation was longer for those choosing depot medroxyprogesterone acetate compared with OCs (17.8 vs 7.4 months, respectively, P =.002). The overall incidence of repeat pregnancy at 12 months postpartum was 10.6%. Among OC and depot medroxyprogesterone acetate users, respectively, 24% and 2.6% became pregnant again, producing a relative risk (RR) of 9.09 (95% confidence interval [CI] 2.1, 39.2) for repeat pregnancy among OC users. The mean time to repeat pregnancy (this was reported instead of the median time whenever the pregnancy rate had not reached 50% at the end of the follow-up period) was longer for depot medroxyprogesterone acetate compared with OC users (17.1 months vs 13.2 months, respectively, P <.001). CONCLUSION: Adolescent mothers using depot medroxyprogesterone acetate injection for contraception have a higher method continuation rate and a lower incidence of repeat pregnancy at 12 months postpartum than those selecting OCs during the same period.

Adolescent↗

[Contraception a year after voluntary interruption of pregnancy].

At the time of conception leading to a RLA, 94 percent of the women were not using medical contraception (intra-uterine contraceptive device or estroprogestin drug). One year after the RLA, only 12 percent of the patients were found not to be using medical contraceptives. Thus, RLA is an event which modifies considerably the contraceptive habits of the patients. It is remarkable that one year after a RLA, 3/4 of the patients continue to use the contraceptive prescribed immediately after RLA.

Abortion, Legal↗

Use and acceptance of the "paper pill". A novel approach to oral contraception.

A randomized, crossover study comparing the acceptance of and attitudes towards two dosage forms of the same oral contraceptive product - a paper presentation and the conventional tablet, was carried out in a network of rural and suburban research centers in the State of Durango, México. The results failed to show any significant advantage (in terms of acceptability or continuation) of the paper formulation. Although two-thirds of the participants indicated a preference for the conventional tablet, there was a high degree of acceptance of the paper formulation among new oral contraceptive acceptors.

Adolescent↗

Norplant implants in the UK: first year continuation and removals.

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.

Capsules↗

The association of depo-medroxyprogesterone acetate and breast cancer.

The use of depo-medroxyprogesterone acetate (DMPA) as an injectable contraceptive for women has continued to be controversial for over 10 years. The U.S. Food and Drug Administration has not approved it for contraceptive use but the World Health Organization has. We undertook a case-control study to clarify the possible association of breast cancer and DMPA use. Subjects were selected from women enrolled in the Grady Memorial Hospital Family Planning Clinic in Atlanta, Georgia, from 1967 to 1979. The risk of breast cancer in DMPA users compared to nonusers is identical. The small number of women with breast cancer, the short average exposure to DMPA, and the lack of detail about the subjects themselves caused us to interpret our results cautiously. However, it seems reasonable to conclude that short-term use of DMPA among black women is not associated with any increased risk of breast cancer.

Adult↗

Experience with NORPLANT in Egypt.

Experience with the contraceptive NORPLANT in Egypt dates back to early 1980 when the first multicentre trial was initiated. To date, more than 3000 women have received this contraceptive at the Assiut University Family Clinic alone. Analysis of the overall experience in this clinic has indicated a 5-year cumulative continuation rate of 51 and a pregnancy rate of 1.8 per 100 women. Clinical pharmacology studies pertaining to the safety of NORPLANT in our community have indicated no deleterious effect on the lipid profile, liver functions and blood coagulation system. Two studies conducted in Egypt have indicated that the initiation of NORPLANT use shortly after delivery does not have any unfavourable effect on lactational performance, or on physical or psychomotor development of the breast-fed infants. This is particularly important in Arab and Moslem cultures where prolonged breast-feeding is emphasized. A study utilizing focus-group discussion to assess users' attitudes to NORPLANT has indicated the need to improve the informational/educational package given in the service by emphasizing certain cultural considerations. On the whole, this first implant method has proven to be safe and acceptable in Egypt, where there is a special need for long-term methods for contraception, particularly as sterilization is not socially acceptable.

Adult↗

Norplant-2 rods: one year experience in Singapore.

Norplant-2 contraceptive implants consist of two silastic rods in which levonorgestrel has been incorporated with the polymer. This study describes our experience with 100 acceptors of the Norplant-2 rods in Singapore. No pregnancies occurred during the first year of use. Menstrual irregularities was the main complaint associated with the use of Norplant-2. However, the incidence of menstrual irregularities appeared to diminish with time and the continuation rate at the end of one year was 95.0 per cent. Thus, it appears that the Norplant-2 rod systems offer a highly effective, convenient means of contraception which should be well accepted in future.

Adult↗

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↗

A field trial of Billings' ovulation method for spacing and limitation of birth.

In spite of constant efforts by health and social workers, existing family planning measures are not used by a vast majority of eligible couples. This is because of the fear that the method may affect their health and happiness. Billings' ovulation method is based on the scientific observation that by noting the changes in cervical mucus, which is clear, slippery and copious in periovulatory period, it is possible to prevent pregnancy by avoiding intercourse during this period. As this method does not require the use of drugs or devices it was decided to promote this method in the urban areas and slums of Patna, Bihar where couples were not using other methods. This is not a comparative study of the cost-effectiveness of Billings' ovulation method versus other contraceptive measures at all. An analysis of 501 cases (267 in urban and 234 in slums) over a period of 2 1/2 years has been presented and it is gratifying to note that the couples from all religions and strata of the society (nearly 47% were slum dwellers) agreed to continue this method.

Adult↗

Oral contraceptive containing natural estradiol for premenopausal women.

An open multicenter trial was performed in six centers in Finland to study the efficacy, safety and acceptability of a new biphasic oral contraceptive pill containing natural estradiol and cyproterone acetate. The participants were 288 women with a mean age of 39.3 +/- 3.4 years (range 30-49) who were willing to use the new pill as their only contraceptive method. In total, 23% of the women were smokers. The cumulative experience was 2800 treatment cycles during the first year. The net 12-month continuation rate was 63%. One pregnancy occurred in a woman who lost 5 tablets in the second treatment cycle, which gives a 12-month cumulative pregnancy rate of 0.4%. Serum progesterone values, determined twice during the third treatment cycle, showed ovulation inhibition in 95% of women. There were no serious side effects. Intermenstrual bleeding was recorded by 35.5% and 24.5% of women at 3 and 12 months, respectively. The bleedings became scantier in most women and dysmenorrhoea disappeared. No changes were observed in total and high density lipoprotein cholesterol concentrations after 1 year. With the exception of intermenstrual spotting, the efficacy, safety and acceptability of the new pill was almost as good as that of the modern low dose oral contraceptives. This is the first pill containing natural estradiol that has gained clinical acceptance and which can also be prescribed for smokers over 35 years old until the climacteric.

Adult↗

Determinants of current contraceptive use among Ghanaian women at the highest risk of pregnancy.

This study uses data from the Ghana Demographic and Health Survey (GDHS) of 1988 to examine factors determining the continued low levels of contraceptive use in Ghana. The women currently using efficient contraception are those who have sexual intercourse regularly, who discuss family planning with their partner, whose husbands approve of the use of family planning, and who live in the northern sector of the country. The finding that husband's approval is an important determinant of efficient contraceptive use has significant policy implications for Ghana and other African countries, to motivate both husbands and wives to share fertility control responsibilities.

Adolescent↗

Preclinical studies of alkylureas as anti-HIV-1 contraceptive.

The HIV-1 epidemic continues to spread at a rate of over 15, 000 new cases daily. HIV-1 transmission through heterosexual contact became the dominant risk for women globally. About half of the over 40 million HIV-1 infected individuals worldwide are now women. The lack of empowerment of women is the fundamental cause for the rampant spread of HIV-1 in women. Topical microbicides applied intravaginally offer an option for female-initiated HIV-1 prevention. There is an urgent need to develop microbicides with and without contraceptive qualities to also address socio-cultural settings where the woman's status is linked to fertility. A safe and efficacious anti-HIV-1 vaginal formulation is not yet available though a large number of candidates are in preclinical or clinical studies. Presently marketed topical microbicides are by and large toxic and damage the vaginal mucosa with frequent use. The microbicidal system of alkylureas evaluated here lends itself to contraceptive and non-contraceptive anti- HIV-1 formulations. Alkylureas are agents that irreversibly disrupt free and intracellular HIV-1, have a wide margin of safety and are spermicidal above their virucidal concentration without any mucosal toxicity. Butylurea, the lead compound is also effective against other sexually transmitted diseases (STDs) while sparing the normal vaginal flora. Alkylureas with longer alkyl chains still have to be explored and may have a greater selective microbicidality.

Administration, Intravaginal↗

Oral contraceptive therapy for polycystic ovary disease after chronic gonadotropin-releasing agonist administration. Predictors of continued ovarian suppression.

OBJECTIVE: To study the beneficial effects of oral contraceptive (OC) therapy following gonadotropin-releasing hormone agonist (GnRH-a) administration in women with polycystic ovary disease (PCOD). STUDY DESIGN: Twenty-three hyperandrogenic women (aged 15-39) were randomized into two groups; GnRH-a (depot every 28 days) for six months or combination therapy (GnRH-a plus OC "addback") for six months. Following six months of treatment with either therapy, all patients received OC therapy for at least six months. The hormonal state was evaluated at three-month intervals. RESULTS: Hormone levels of luteinizing hormone (LH), testosterone (T) and free T remained suppressed within the normal range in 11 of 17 patients (65%) during the six months of OC only therapy, while the other six patients showed "escape" from suppression, with the LH, T and free T concentrations rising to pre-GnRH-a treatment levels. Use of OC addback therapy did not potentiate the long-acting therapeutic effect of GnRH-a pretreatment; three of six patients in the escape group were pretreated with combination therapy and three with GnRH-a only. CONCLUSION: In the majority of women with PCOD, OC therapy following GnRH-a administration was effective in maintaining ovarian androgen suppression. Failure to maintain ovarian suppression in this patient population was associated with higher elevations of baseline free T concentrations.

Adolescent↗

Comparison of copper T-200 with Lippes loop as a contraceptive device.

A comparison has been made between Lippes loop and T Cu 200 intra-uterine contraceptive device with respect to their acceptability and effectiveness in a developing country. A total of 1054 patients were studied; 697 with Lippes loop and 357 with T Cu 200. The ages of the patients ranged between 14 and 44 years, with a peak age of 21-25 years for T Cu 200 and 26-30 for Lippes loop. The event rates were similar but T Cu 200 displayed lower expulsion rate, lower intermenstrual bleeding rate and a lower incidence of pelvic inflammatory disease. The Lippes loop had lower event rate for the other parameters considered, pregnancy and pelvic pain. The continuation rate was similar for both devices. Both devices are useful for women who wish to space out their children but for those who wish to achieve effective contraception for more than 5 years, Lippes loop should be the IUD of choice.

Barium Sulfate↗

Norplant contraceptive acceptability among women in five Asian countries.

An analysis of 1,882 Asian acceptors of Norplant implants indicates that method acceptability remained high among the 882 women who used the method for five years. Women who discontinued early from the study were, on average, younger than those who completed five years of use. Also, they had fewer live births and were more likely to desire additional children. Overall, about 70% of the women in these countries found the Norplant implant method to be very favorable. The majority (> 40%) of the women found the ease and duration of use of the method to be most attractive, while menstrual disturbances were the least-liked aspect of the method. Although it was apparent that there are still some potential obstacles to Norplant implant acceptance, most noticeably concerns about menstrual irregularities, interest in continuing the method after five years of use is high. Further research of issues related to Norplant implant acceptability may improve continuation rates and overall client satisfaction.

Adult↗