A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception

BackgroundThis study evaluates the willingness of women presenting for emergency contraception (EC) to enroll in a study offering the copper intrauterine device (IUD) or oral levonorgestrel (LNG) and follows up the two groups for 6 months after EC administration to compare use of an effective method of contraception.Study DesignThis prospective observational study offered these two methods to women presenting for EC. The primary outcome was use of an effective method of contraception 6 months after presenting for EC.ResultsThirty-four women (60%) chose oral LNG and 23 (40%) chose the copper IUD. One month after presenting for EC, 21 (96%) of 22 in the IUD group were still using the IUD and all 22 were using an effective method of contraception (efficacy ≥92%). In the LNG group, 13 (52%) of 25 were using an effective method of contraception (p<.001). At 6 months, 9 (69%) of 13 IUD users and 11 (52%) of 21 oral LNG EC users were using an effective method (p=NS).ConclusionWomen presenting for EC were willing to enroll in a study offering the copper IUD or oral LNG.     

Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study

ObjectivesWe assessed intrauterine device (IUD) preference among women presenting for emergency contraception (EC) and the probability of pregnancy among concurrent oral levonorgestrel (LNG) plus LNG 52 mg IUD EC users.MethodsWe offered women presenting for EC at a single family planning clinic the CuT380A IUD (copper IUD) or oral LNG 1.5 mg plus the LNG 52 mg IUD. Two weeks after IUD insertion, participants reported the results of a self-administered home urine pregnancy test. The primary outcome, EC failure, was defined as pregnancies resulting from intercourse occurring within five days prior to IUD insertion.ResultsOne hundred eighty-eight women enrolled and provided information regarding their current menstrual cycle and recent unprotected intercourse. Sixty-seven (36%) chose the copper IUD and 121 (64%) chose oral LNG plus the LNG IUD. The probability of pregnancy two weeks after oral LNG plus LNG IUD EC use was 0.9% (95% CI 0.0–5.1%). The only positive pregnancy test after treatment occurred in a woman who received oral LNG plus the LNG IUD and who had reported multiple episodes of unprotected intercourse including an episode more than 5 days prior to treatment.ConclusionsStudy participants seeking EC who desired an IUD preferentially chose oral LNG 1.5 mg with the LNG 52 mg IUD over the copper IUD. Neither group had EC treatment failures. Including the option of oral LNG 1.5 mg with concomitant insertion of the LNG 52 mg IUD in EC counseling may increase the number of EC users who opt to initiate highly effective reversible contraception.ImplicationsConsideration should be given to LNG IUD insertion with concomitant use of oral LNG 1.5 mg for EC. Use of this combination may increase the number of women initiating highly effective contraception at the time of their EC visit.     

Copper T 380A IUD and magnetic resonance imaging

BACKGROUND: Concerns about women who have implanted or in situ medical devices undergoing magnetic resonance (MR) imaging engender the need for testing. Prior testing of the Copper T 380A intrauterine device (IUD) has been done using MR systems of 1.5 T or less. This study was performed to test this IUD in a MR system of 3.0 T. MATERIALS AND METHODS: In vitro safety testing was done via the Copper T 380A IUD using a GE Signa LX 3.0-T MR system. Variables tested included deflection, torque, heating and artifact. RESULTS: No significant deflection, torque, heating or artifact was found in this in vitro testing model. CONCLUSION: The outcomes measured revealed no safety concerns for the use of the Copper T 380A IUD at 3.0 T under the conditions of testing. This finding is compatible with the new standards adopted by the American Society for Testing and Materials and the Food and Drug Administration (FDA), with a rating of "MR Conditional."     

Effectiveness of levonorgestrel emergency contraception given before or after ovulation--a pilot study

BACKGROUND: Although widely used, the mechanisms of action of the levonorgestrel emergency contraceptive pill (LNG ECP) are still unclear. There are increasing data to indicate that LNG is particularly effective as an ECP by interrupting follicular development and ovulation. An important outstanding question is whether it has any effect on fertilization or implantation. METHOD: Ninety-nine women participated; they were recruited at the time they presented with a request for emergency contraception. All women took LNG 1.5 mg in a single dose during the clinic consultation. A blood sample was taken immediately prior to ingestion of the ECP for estimation of serum LH, estradiol and progesterone levels to calculate the day of ovulation. The specimens were analyzed in a single batch. Based on these endocrine data, we estimated the timing of ovulation to be within a +/-24-h period with an accuracy of around 80%. Women were followed up 4-6 weeks later to ascertain pregnancy status. The effectiveness of ECP when taken before and after ovulation was determined. RESULTS: Three women became pregnant despite taking the ECP (pregnancy rate, 3.0%). All three women who became pregnant had unprotected intercourse between Days -1 and 0 and took the ECP on Day +2, based on endocrine data. Day 0 was taken as ovulation day. Among 17 women who had intercourse in the fertile period of the cycle and took the ECP after ovulation occurred (on Days +1 to +2), we could have expected three or four pregnancies; three were observed. Among 34 women who had intercourse on Days -5 to -2 of the fertile period and took ECP before or on the day of ovulation, four pregnancies could have been expected, but none were observed. We found major discrepancies between women's self-report of stage of the cycle and the dating calculation based on endocrine data. CONCLUSION: These data are supportive of the concept that the LNG ECP has little or no effect on postovulation events but is highly effective when taken before ovulation.     

The Ombrelle-380 IUD: a pilot study

The initial results of a pilot trial (314 insertions and 3784 woman-months of experience at 18 months) suggest the low expulsion rate (0.0) and high clinical effectiveness (pregnancy rate 0.0) of the Ombrelle-380, a new highload copper-releasing IUD of French origin.

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Resumen Los resultados iniciales en un estudio piloto (314 inserciones y 3784 meses-mujer de experiencia en 18 meses) sugieren la baja expulsión (tasa de expulsión 0,0) y la alta eficacia clínica (tasa de embarazos 0,0) del Ombrelle-380, un DIU nuevo de alta carga liberadora de cobre, de origen francés.

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Resumé Les premiers résultats d'un essai pilote (portant sur une expérience de 314 insertions et 3784 femmes-mois après 18 mois) indiquent les faibles possibilités de rejet (taux d'expulsion: 0,0) et l'efficacité clinique élevée (taux de grossese: 0,0) de l'Ombrelle-380, nouveau DIU d'origine française libérant une forte charge du cuivre qu'il contient.

     

Emergency contraception with a copper IUD or oral levonorgestrel: an observational study of 1-year pregnancy rates

Objective

We investigated the 1-year pregnancy rates for emergency contraception (EC) users who selected the copper T380 intrauterine device (IUD) or oral levonorgestrel (LNG) for EC.

Study Design

This prospective study followed women for 1 year after choosing either the copper T380 IUD or oral LNG for EC. The study was powered to detect a 6% difference in pregnancy rates within the year after presenting for EC.

Results

Of the 542 women who presented for EC, agreed to participate in the trial and met the inclusion criteria, 215 (40%) chose the copper IUD and 327 (60%) chose oral LNG. In the IUD group, 127 (59%) were nulligravid. IUD insertion failed in 42 women (19%). The 1-year follow-up rate was 443/542 (82%); 64% of IUD users contacted at 1 year still had their IUDs in place. The 1-year cumulative pregnancy rate in women choosing the IUD was 6.5% vs. 12.2% in those choosing oral LNG [hazard ratio (HR) 0.53, 95% confidence interval (CI): 0.29–0.97, p=.041]. By type of EC method actually received, corresponding values were 5.2% for copper IUD users vs. 12.3% for oral LNG users (HR 0.42, 95% CI: 0.20–0.85, p=.017). A multivariable logistic regression model controlling for demographic variables demonstrates that women who chose the IUD for EC had fewer pregnancies in the following year than those who chose oral LNG (HR 0.50, 95% CI: 0.26–0.96, p=.037).

Conclusion

One year after presenting for EC, women choosing the copper IUD for EC were half as likely to have a pregnancy compared to those choosing oral LNG.

Implications

Compared to EC users who choose oral levonorgestrel, those who select the copper IUD have lower rates of pregnancy in the next year. Greater use of the copper IUD for EC may lower rates of unintended pregnancy in high-risk women.     

Intrauterine contraception for adolescents aged 14-18 years: a multicenter randomized pilot study of Levonorgestrel-releasing intrauterine system compared to the Copper T 380A

Background

Intrauterine contraception can provide adolescents with effective, long-term contraception as well as with other health benefits. In adult populations, intrauterine contraception rates highly in patient satisfaction and safety. It is rarely prescribed to adolescents because of limited data.

Study Design

Multicenter, randomized, controlled, participant-blinded pilot study of 14-18-year-old females assigned to the Copper T 380A intrauterine device or the Levonorgestrel Intrauterine System. Participants were followed up for 6 months following insertion.

Results

We enrolled 23 participants; 12 received the Levonorgestrel Intrauterine System, and 11 received the Copper T 380A. At 6 months, the continuation rates were 75% for the Levonorgestrel Intrauterine System users and 45% for the Copper T 380A users (p=.15). Two Copper T 380A users experienced partial expulsion. Heavy bleeding and pelvic pain were the most commonly reported side effects. Participants rated both methods favorably.

Conclusions

This study shows that at 6 months, though not statistically significant, adolescent continuation rates trended towards being greater with the Levonorgestrel Intrauterine System compared to the Copper T 380A. These pilot data will be helpful in the design of a larger trial of intrauterine contraception use among adolescents.     

Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS.

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.     

Contraceptive efficacy of the Copper T380A and the Multiload Cu250 IUD in three developing countries

The clinical performance of the Copper T380A (TCu380A) and the Multiload 250 (MLCu250) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in three developing countries.The gross cumulative life-table pregnancy rate of the TCu380A IUD was significantly lower than the rate with the MLCu250 IUD at 12 months (0.5 and 1.2, respectively,p<0.01). No statistically significant differences between the two study IUDs were found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. TCu380A IUD users were more likely to report experiencing increased dysmenorrhea (p<0.01) or intermenstrual pelvic pain (p<0.01) than were MLCu250 IUD users. However, few of these users discontinued use of their assigned IUD because of having experienced menstrual bleeding disturbances or intermenstrual pelvic pain.These data indicate that the TCu380A IUD may be a better option than the MLCu250 IUD for women wishing to practice highly effective long-term birth control without having to resort to hormonal methods.

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Resumen El resultado clínico de los dispositivos intrauterinos (DIU) Copper T380A y Multiload 250 (MLCu250) se evaluó durante 12 meses en un grupo de mujeres a quienes se había colocado uno de los dos DIU. Los resultados corresponden a un ensayo clínico aleatorizado efectuado en cuatro emplazamientos de investigaciones en colaboración situados en tres países en desarrollo.La tasa bruta acumulativa de embarazo de las tablas de vida del DIU TCu380A fue significativamente inferior a la tasa correspondiente al DIU MLCu250 a los 12 meses (0,5 y 1,2, respectivamente,p<0,01)). No hubo diferencias estadísticamente significativas entre los dos DIU del estudio con respecto a su expulsión o retiro debido a microrragia/dolor, razones personales, razones médicas o embarazo planificado. Era más probable que las usuarias del DIU TCu380A notificaran mayor dismenorrea (p<0,01) o dolor pélvico intermenstrual (p<0,01) que las usuarias del DIU MLCu250. Sin embargo, un número menor de este grupo de usuarias dejó de utilizar el DIU que le había sido asignado por haber experimentado trastornos menstruales de microrragia o dolor pélvico intermenstrual.Estos datos indican que el DIU TCu380A podría ser una mejor opción que el DIU MLCu250 para las mujeres que desean praticar un control de la natalidad a largo plaza altamente eficaz sin tener que recurrir a métodos hormonales.

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Resumé Les résultats cliniques des dispositifs intra-utériens (DIU) Copper T38OA (TCu380A) et Multiload 250 (MLCu250) ont été évalués pendant 12 mois chez un groupe de femmes qui portaient l'un ou l'autre de ces dispositifs. Les résultats proviennent d'un essai clinique randomisé, effectué en collaboration par quatre établissements de recherche dans trois pays en développement.Au terme de 12 mois, le taux brut cumulé de grossesses des tables de survie pour le dispositif TCu380A était significativement inférieur au taux correspondant pour le dispositif MLCu250 (0,5 et 1,2 respectivement,p<0,01). Aucune différence statistiquement significative entre les deux dispositifs étudiés n'a été constatée du point de vue de l'expulsion du DIU ou de son retrait pour cause de microrragie/douleurs, pour des raisons personnelles ou médicales ou pour une grossesse planifiée. Les utilisatrices du TCu380A ont plus fréquemment signalé une dysménorrhée (p<0,01) ou des douleurs pelviennes intermenstruelles (p<0,01) que les utilisatrices du MLCu250. Peu nombreuses était cependant cells qui avaient, en raison de perturbations du flux menstruel ou de douleurs pelviennes intermenstruelles, abandonné l'usage du dispositif qui leur avait été assigné.Ces résultats indiquent que le dispositif TCu380A représente peut-être une meilleure solution que le dispositif MLCu250 pour les femmes recherchant à long terme une méthode hautement efficace de régulation des naissances, sans avoir recours aux méthodes hormonales.

     

Factors associated with discontinuation rates of the Copper T380A IUD in a Peruvian public hospital

The objectives of this study were to evaluate performance and causes of discontinuation of the Copper T380A IUD by users at the Family Planning Service at Hospital Arzobispo Loayza in Lima, Peru, during a period of three years. The study included 3167 acceptors of the CuT380A attending the service during 1992-1994. IUDs were inserted during interval timing. Follow-up was at 1, 12, 24 and 36 months after insertion. The following events were recorded: number of pregnancies, expulsions and all causes of discontinuation. The cumulative rates per 100 woman-years using the life-table method was calculated. Also calculated were the relative risks for expulsion and for pregnancy. At the end of the study, 361 women had discontinued the method for various reasons, whereas 1667 women continued using the method. The lost-to-follow-up proportion increased over time from 35.9 per 100 woman-years for the first year to 38.2 for the third year. The cumulative discontinuation rate over three years was 22.6±1.3 (cumulative rate±standard error) per 100 woman-years. The cumulative pregnancy rate for three years was 1.2±0.4 per 100 woman-years, whereas the cumulative rate of expulsion was 4.9±0.4 for the first, 6.4 for the second and 6.8 for the third year. The main cause of discontinuation during the first year of use was expulsion (4.9 per 100 woman-years) followed by personal reasons (2.1 per 100 woman-years). At the end of the third year, the main cause was personal reasons (11.4) and the second cause was expulsion (6.8). A higher probability of expulsion, pregnancy and discontinuation for bleeding and/or pain was associated with age less than 20 years. In conclusion, the effectiveness of the CuT380A IUD after three years of use was 98.8 per 100 woman-years, whereas continuation was 39.2, and loss to follow-up increased over time.     

Minimum effectiveness of the levonorgestrel regimen of emergency contraception

The standard method for estimating the effectiveness of emergency contraceptive pills (ECPs) uses external data to calculate the proportion of expected pregnancies averted by the treatment. Because these data may not be applicable to ECP study populations, this approach could result in substantial overestimation of effectiveness. We used data from two published randomized trials of the levonorgestrel and Yuzpe ECP regimens to calculate the minimum effectiveness of the levonorgestrel regimen. Conservatively assuming that the Yuzpe regimen was entirely ineffective in these trials, we estimate that the levonorgestrel regimen prevented at least 49% of expected pregnancies (95% confidence interval: 17%, 69%). Because physiologic data suggests that the Yuzpe regimen does, in fact, have some efficacy, the effectiveness of the levonorgestrel regimen is likely to be higher than our minimum estimate.     

Bioavailability of the Yuzpe and levonorgestrel regimens of emergency contraception: vaginal vs. oral administration

Separate crossover studies compared the bioavailability of oral vs. vaginal routes of administration for the Yuzpe (n=5) and levonorgestrel regimens (n=4) of emergency contraception. Twice the standard dose of the Yuzpe regimen (200 microg of ethinyl estradiol, 1000 microg of levonorgestrel) or the levonorgestrel regimen (1500 microg of levonorgestrel) was self-administered vaginally. One week later, each subject received orally the standard dose of the assigned medication. Serial blood samples were collected over 24 h and assayed for levonorgestrel and ethinyl estradiol (for the Yuzpe regimen only). Paired t tests were used to compare oral vs. vaginal administration for maximum concentration (Cmax), time to maximum concentration (Tmax) and area under the curve over 24 h (AUC0-24). Relative bioavailability (vaginal/oral) was derived from AUC0-24. Vaginal administration of double the standard dose of the Yuzpe regimen resulted in a lower Cmax (vaginal=5.4 vs. oral=14.6 ng/mL, p=.038) and a later Tmax (5.9 vs. 2.0 h, p=.066) for levonorgestrel, compared to oral administration. Corresponding ethinyl estradiol concentrations were higher (786 vs. 391 pg/mL, p=.039) and peaked later (4.0 vs. 1.9 hr, p=.154) with vaginal administration. Relative bioavailabilities for levonorgestrel and ethinyl estradiol were 58% and 175%, respectively. Similarly, vaginal administration of the levonorgestrel regimen resulted in a lower Cmax (vaginal=5.4 vs. oral=15.2 ng/mL, p=.006) and a later Tmax (7.4 vs. 1.3 h, p=.037) for levonorgestel, compared to oral administration. The relative bioavailability was 62%. Our preliminary data suggest that vaginal administration of these emergency contraception regimens appears to require at least three times the standard oral dose to achieve equivalent systemic levonorgestrel concentrations.     

A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs

Objectives

We explored levonorgestrel (LNG) concentrations, bleeding patterns and endometrial thickness in women with epilepsy (WWE) initiating an LNG-intrauterine device (IUD) co-administered with antiepileptic drugs (AEDs).