Because Norplant provides effective contraception for 5 years, it is an excellent choice for many women. However, it has side effects that have prompted early removal in a significant number of women. Nurses who educate and counsel women about Norplant before insertion and provide support and management of side effects afterward can increase user satisfaction and long-term continuation.

This report attempts to present a comprehensive analysis of the acceptability, side effects, and efficacy of Norplant as used in rural areas, based on a field experiment conducted in four counties in Hebei and Shandong Provinces, China. The initial acceptance of Norplant was relatively high but waned after the first year in three of the four counties. Compared with clinical trials, the current study shows a lower prevalence but similar patterns of side effects. The pregnancy rate during the first two years of use is similar to that found in large-scale clinical trials conducted in China, but discontinuation due to other reasons is lower. A three-level logistic regression analysis shows significant variation in the probability of discontinuation due to side effects across counties. It also indicates an increase in the conditional probability of discontinuation with the duration of use. Whereas introducing Norplant and achieving a very low failure rate and high continuation rate in rural areas is feasible under diverse socioeconomic conditions, the results vary significantly across different areas. Particular attention should be paid to the local factors that may affect results.

BACKGROUND

Use of a reliable contraception method has become an inclusion criterion in prevention trials to minimize time off product. We report on hormonal contraceptive prevalence, uptake, sustained use and correlates of use in the Microbicides Development Programme (MDP 301) trial at the Masaka Centre in Uganda.

METHODS

HIV negative women in sero-discordant relationships were enrolled and followed-up for 52 to 104 weeks from 2005 to 2009. Contraceptive use data was collected through self-report at baseline and dispensing records during follow-up. Hormonal contraceptives were promoted and provided to women that were not using a reliable method at enrolment. Baseline contraceptive prevalence, uptake and sustained use were calculated. Uptake was defined as a participant who reported not using a reliable method at enrolment and started using a hormonal method at any time after. Logistic regression models were fitted to investigate predictors of hormonal contraceptive uptake.

RESULTS

A total of 840 women were enrolled of whom 21 aged ≥50 years and 12 without follow-up data were excluded; leaving 807 (median age 31 IQR 26-38) in this analysis. At baseline, 228 (28%) reported using a reliable contraceptive; 197 hormonal, 28 female-sterilisation, two IUCD and one hysterectomy. As such 579 were not using a reliable contraceptive at enrolment, of whom 296 (51%) subsequently started using a hormonal contraceptive method; 253 DMPA, four oral pills, and two norplant. Overall 193 (98%) existing users and 262 (88%) new users sustained use throughout follow-up. Independent correlates of hormonal contraceptive uptake were: younger women ≤30 years, aOR = 2.5, 95% CI: 1.7-3.6 and reporting not using contraceptives at baseline due to lack of access or money, breastfeeding or other reasons, in comparison to women who reported using unreliable method.

CONCLUSIONS

Promotion and provision of hormonal contraception doubled the proportion of women using a reliable method of contraception. Uptake was pronounced among younger women and those not previously using a reliable method because of lack of access or money, and breastfeeding. Promotion and provision of hormonal contraceptives in trials that require the interruption or discontinuation of investigational products during pregnancy is important to reduce the time off product.

BACKGROUND

Protocol Number ISRCTN64716212 .

Levonorgestrel plasma levels were determined by a specific radioimmunoassay in a group of 110 women at various intervals between 1 and 60 months following implantation of six silastic capsules containing levonorgestrel (Norplant). The implants were placed subdermally in the anterior aspect of the forearm. Blood samples were taken twice a week for six consecutive weeks in each subject. Blood drawn from the antecubital vein ipsilateral to the implant site contained two to three times more levonorgestrel than contralateral samples. Average systemic plasma levels represented by contralateral samples ranged from 0.35 +/- 0.03 to 0.29 +/- 0.02 ng/ml (Mean +/- S.E.) in the first and fifth year, respectively. The difference between these values is statistically significant at the 6% level. The results of the regression analysis of individual levels suggest that the decline observed throughout the first five years is mainly due to an early decrease taking place in the first two years. When the sampling period was repeated in the same subjects two or three times 10 to 24 months apart, no significant difference was found. A significant negative correlation was found between plasma levonorgestrel levels and body weight and body surface. The data indicate that the contraceptive efficacy of Norplants during the first five years of use is associated with sustained release of levonorgestrel and is in keeping with the estimated life span of Norplants of seven years.

OBJECTIVE

To alert clinicians to risk factors associated with levonorgestrel implant (Norplant; Wyeth-Ayerst Laboratories, Philadelphia, PA) failures in the adolescent population and discuss alternatives.

METHODS

Medline search of articles pertaining to the use of levonorgestrel implants in the adolescent population.

METHODS

All articles pertaining to the use of levonorgestrel implants in adolescents.

CONCLUSIONS

Levonorgestrel subdermal implants, Norplant, have been successfully used worldwide as contraceptives. Clinical trials suggest that pregnancy rates while using levonorgestrel implants are positively correlated with increased body weight. In addition, pregnancy rates may be higher in women below age 25 years. Finally, patients who report regular menstrual cycles on levonorgestrel implants may be at greater risk for method failure. Consequently, despite its apparent success, levonorgestrel implants have some significant but little-known limitations that should be considered in initial adolescent patient selection, education, and postinsertion medical supervision.

OBJECTIVE

To evaluate the long-term efficacy and health problems associated with Norplant implants and re-implants after 5 full years of first implants.

METHODS

From 1984 to 1988, 1657 women accepted first implants of Type I and Type II of Norplant, and 394 first acceptors had a re-implant, at a clinic for study. The clinical records and annual follow-up data of acceptors were analyzed. The life-table technique was the main method used.

RESULTS

The continuation rates were very high. The cumulative pregnancy rates at 1, 3 and 5 full years of use were 0.0%, 0.1% and 0.7%, respectively. Users with heavier body weight had higher pregnancy rates. The rate of menstrual disturbances peaked at 73% after 3 months and consistently decreased to 20% at 5 years of use. Rates of menstrual disturbances associated with re-implants were much lower.

CONCLUSIONS

Norplant is extremely effective and safe for long-term use.

Recent publications about emergency and implantable contraception focused on increasing the awareness about emergency contraceptive methods and on updating readers about the controversies surrounding Norplant. Both emergency and implantable contraception have excellent safety and efficacy profiles, yet neither has realized its potential for widespread use. This review addresses these concerns and attempts to place these issues in perspective.