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PubMed2002

Contraceptive efficacy and tolerability with a novel combined contraceptive vaginal ring, NuvaRing.

NuvaRing is a novel combined contraceptive vaginal ring that releases 15 microg of ethinylestradiol and 120 microgram etonogestrel per day. Each ring is used for one cycle, comprising 3 weeks continuous use of the ring followed by a 1-week ring-free period. The contraceptive efficacy and safety of NuvaRing have been studied in a 1-year, open study conducted in 1,145 women. Six pregnancies occurred in 12,109 cycles of exposure, giving a Pearl index of 0.65 (95% confidence interval (CI), 0.24-1.41). However, three of the six women violated the NuvaRing regimen in the cycle of conception. Compliance with the prescribed regimen was high, with criteria being fulfilled in 90.8% of cycles. During the 1 year of the study, 41% of the women did not experience any adverse events. The most frequently reported treatment-related adverse events were headache (6.6%), leukorrhea (5.3%) and vaginitis (5.0%). There was a low incidence of estrogen-related adverse events such as nausea (2.8%) and breast tenderness (1.9%). A total of 173 women (15.1%) discontinued due to an adverse event, with device-related events (comprising ring expulsion, foreign body sensation or coital problems) being the most commonly reported (2.6%). There were no clinically relevant changes in blood biochemistry, hematology, blood pressure, heart rate, body weight, physical examination or cervical cytology. In conclusion, NuvaRing is an effective contraceptive that is well tolerated, has a good safety profile and is not associated with unwanted effects on the cervix.

Consumer Product Safety↗
PubMed1995

Menstruation, menarche, and sexuality in the public school curriculum: school nurses' perceptions.

Nurses employed by schools and health departments have varying responsibilities for curricula related to menstruation, menarche, and sexuality. Nevertheless, the school nurse is usually a source of information on these subjects whether employed full-time in school health or also participating in other nursing roles in the community. This survey examines the involvement of school nurses in curricula related to human reproduction including contraception. Data about their involvement in these classroom topics provides a basis for evaluating their roles and making recommendations for subsequent continuing education programs for school health nurses.

Adolescent↗
PubMed2004

Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparative study.

This 1-year randomized study was carried out at family-planning clinics of two university hospitals to compare the safety and acceptability of a levonorgestrel-releasing intrauterine system (LNG IUS) and oral contraceptives (OCs) in young nulliparous women. The study population consisted of 200 women aged 18-25 years seeking contraception. Ninety-four women entered the LNG IUS group and 99 entered the OC group. Continuation rates, reasons leading to discontinuation, adverse events, menstrual questionnaires, subjective well-being and sexual behavior were evaluated. Nineteen women (20%) in the LNG IUS group discontinued the study during the 1-year observation period, and 27 discontinued (27%) in the OC group. The most common reason (31%) for discontinuation in the IUS group was pain. In the OC group, hormonal side effects were the predominant medical reason for study termination. The safety and acceptability of the LNG IUS for contraception was observed to be as good as with OCs, with a high continuation rate.

Adolescent↗
PubMed2005

Acceptability and feasibility of continuous diaphragm use among sex workers in Madagascar.

OBJECTIVES: The diaphragm, a woman controlled, reusable contraceptive device, might prevent some sexually transmitted infections (STIs). We assessed the acceptability and feasibility of use of silicone Wide-Seal Arcing Diaphragms (Milex Products, Chicago, IL, USA) by sex workers in Madagascar. METHODS: Over 8 weeks, we evaluated method acceptability by examining patterns of and problems with women's diaphragm use. We also evaluated several measures of study feasibility, including recruitment and follow up methods. RESULTS: 91 women from three cities (Antananarivo, Tamatave, and Mahajanga) participated, and 87 (96%) completed follow up. At enrolment, participants reported a median of six sex acts with five clients in the previous week. During the follow up period, participants reported a median of three sex acts with three clients during the previous 2 days, and self reported continuous diaphragm use during the previous day increased from 87% to 93%. Seven women became pregnant (incidence 53 pregnancies per 100 woman years). Self reported use of male condoms and diaphragms was fairly constant over the study period: women reported condom use in 61% to 70% of acts and diaphragms in 95% to 97% of acts. The number of participants reporting diaphragm problems decreased from 15 (16%) at the first visit to six (7%) at the final visit. 20 women (22%) needed replacement devices during follow up because their original diaphragms were lost, were the wrong size, or became seriously damaged. CONCLUSIONS: Given the high use and steady decrease in reported problems during the study, we believe diaphragms are acceptable and feasible in this resource poor, low education sex worker population.

Adolescent↗
PubMed2000

Barrier methods of contraception.

Despite the problems associated with coitus-dependent methods of contraception, barrier methods have an important role. The fact that they work as contraceptives without systemic effects makes them particularly appropriate for women with medical conditions that prevent the use of hormonal contraception. In addition, condoms and perhaps all barrier methods provide protection from sexually transmitted infections, making them essential for sexually active women at risk for STDs. Their continued importance is evidenced by the ongoing research to develop and improve barrier methods of contraception.

Condoms↗
PubMed2004

Effects of oral contraceptives on bone mineral density.

Osteoporosis is a major health problem that leads to a high incidence of spine, radial, and hip fractures. It is now well recognized that a chronically hypoestrogenic state increases bone turnover that, in turn, causes a critical decrease in bone mineral density (BMD), an important determinant of fracture risk. During the premenopausal period, hypogonadism can have deleterious effects on skeletal health by reducing peak bone mass or inducing precocious bone loss. In young women, hypothalamic amenorrhea, caused by gonadotropin-releasing hormone pulsatility dysregulation, is often associated with bone loss. Although the relationship between hypothalamic amenorrhea and bone density is not completely understood, the most plausible intervention for this disorder at the moment seems to be the use of hormone replacement. Oral contraceptives are associated with an improvement in BMD if assumed upon the onset of anovulatory cycles and, therefore, estrogen deficiency, but confer no benefit in healthy women with normal ovarian function. In perimenopausal oligomenorrheic women, the use of oral contraceptives seems to have bone-sparing effects. In conclusion, the protective role of oral contraceptives on bone density is biologically plausible, since this treatment represents a replacement therapy with continuous exposure to exogenous estrogens.

Bone Density↗
PubMed1999

Oral contraceptives and compliance: reaction to cardiovascular alarm among users.

The effectiveness of oral contraceptives (OC) is dependent on correct daily intake as well as continuous use. The latest cardiovascular alarm in 1995 led to discontinuations, presumably due to concerns about the long-term safety of OCs. The aim of this study was to investigate women's experiences and concerns about OCs in general as well as after the latest cardiovascular alarm. In 1993 and 1996, questionnaires were offered to 645 and 644 consecutive women visiting a midwife or a gynecologist at eleven family planning clinics in order to get their first prescription of oral contraceptives or to renew their prescription. The study was carried out in Uppsala, a city in Sweden with 180000 inhabitants. In 1993, 95%, answered the questionnaire and in 1996 the corresponding figure was 92%. Change of brand was common and increased from 38% in 1993 to 44% in 1996. Mild side-effects were reported by about 25%. Concerns about oral contraceptives increased from 36% to 41% (p < 0.01), particularly regarding the risk for thrombosis. Fewer than 1% expressed this concern in 1993 but 29% did so in 1996. Negative media coverage leads to increased concerns and declining confidence among users of oral contraceptives and has to be met by adequate oral and written information by the counsellor.

Adolescent↗
PubMed2001

Patient communication and counseling on contraception and hormone replacement therapy.

Many women are unaware of the wide range of benefits resulting from hormonal therapy. Clinicians need to improve their ability to counsel patients about the benefits and risks of oral contraceptives (OCs) and hormone replacement therapy to improve patient compliance and willingness to continue therapy. For reproductive-age women, choosing the lowest effective estrogen/progestin dose will reduce the side effects and bleeding irregularities that are major reasons for patient discontinuation. Analysis has shown that compared with OCs the new transdermal contraceptive system, which is expected to be on the market in 2002, has better outcomes and lower costs at all ages.

Administration, Cutaneous↗
PubMed2000

Barriers to adolescent adherence to contraception. Knowledge Of depo provera timing

Background: Depo Provera is a long-acting progestin contraceptive method that is both highly effective and safe. However, continuation rates at one-year range from 30-42%. It has been suggested that one common reason for discontinuation is poor adherence with appointments. Poor adherence could be related to lack of knowledge regarding the timing of the next injection. Therefore, the purpose of the current investigation was to examine whether adolescent girls were knowledgeable about when their next injection was due.Methods: Adolescent girls were recruited from an urban-based adolescent clinic to participate in a longitudinal study of psychosexual development. The girls were seen every 6 months over three years. At the last three visits, those adolescents on Depo Provera were asked when their next injection was due. Responses were coded as accurate if the date given was within 10-14 weeks of the last injection. Results: There were 45 girls who were using Depo Provera and seen for at least one study visit. The girls ranged in age from 15-19 years, and 87% were African-American; the remainder were Caucasian. 22 girls were seen/and on Depo Provera for 1 visit, 12 for 2 visits, and 11 for 3 visits. Collapsing their answers across visits, 27 of girls were always correct, 11 were sometimes correct, and 7 were never correct. Race and age were not related to whether they were always correct, sometimes correct, or never correct. At the last visit, we examined whether or not length of time on Depo Provera was related to correctness. The relationship appeared to be curvilinear. That is, those girls who had been on Depo Provera the longest time (>/= 18 months) and the least (< 6 months) time were most likely to be correct.Conclusions: This study demonstrates that many (40%) adolescents do not know when their injection is due, and in fact, the correctness of adolescents' knowledge is not consistent over time. Age and race were not significantly related to knowledge of timing. Therefore, ALL adolescents should be provided with reminders about the timing of their next injection. Finally, the curvilinear relationship needs to be examined further. This finding that adolescents on Depo Provera for 6-12 months were the least knowledgeable is consistent with research on oral contraceptive adherence indicating this is a vulnerable time period for contraceptive discontinuation.

Journal Article↗
PubMed1984

Issues in fertility control for mentally retarded female adolescents: I. Sexual activity, sexual abuse, and contraception.

Little information is available about sexual activity, sexual assault, and contraceptive use among mentally retarded adolescents. The experience in these areas among 87 mentally retarded females is reviewed. (A companion paper focuses on these patients' parental attitudes toward sterilization.) All subjects attended a multiservice adolescent clinic with a large developmentally disabled patient group. Charts were reviewed and 69 parents were interviewed. The patients had an age range from 11 to 23 years (mean 16.7). Forty-one subjects were mildly retarded (IQ 55 to 69), 23 were moderately retarded (IQ 41 to 54), and 23 were severely retarded (IQ less than 41). Half of the mildly retarded had had sexual intercourse, a proportion comparable to the general adolescent population. Thirty-two percent of the moderately retarded and nine percent of the severely retarded adolescents had had intercourse. One third of the mildly retarded and one fourth of the moderately retarded adolescents had been victims of rape or incest. Continued sexual activity correlated with sexual abuse, but the majority of victims had no prior or subsequent evidence of intercourse. Forty-two subjects (48%) had used contraception at some time; intrauterine devices and injectable medroxyprogesterone acetate were preferred to oral contraceptives. Six of the 14 patients (43%) who continued sexual activity became pregnant, suggesting that currently available contraception is not providing sufficient protection.

Adolescent↗
PubMed2001

Competing approaches to analysis of failure times with competing risks.

For the analysis of time to event data in contraceptive studies when individuals are subject to competing causes for discontinuation, some authors have recently advocated the use of the cumulative incidence rate as a more appropriate measure to summarize data than the complement of the Kaplan-Meier estimate of discontinuation. The former method estimates the rate of discontinuation in the presence of competing causes, while the latter is a hypothetical rate that would be observed if discontinuations for the other reasons could not occur. The difference between the two methods of analysis is the continuous time equivalent of a debate that took place in the contraceptive literature in the 1960s, when several authors advocated the use of net (adjusted or single decrement life table rates) rates in preference to crude rates (multiple decrement life table rates). A small simulation study illustrates the interpretation of the two types of estimate - the complement of the Kaplan-Meier estimate corresponds to a hypothetical rate where discontinuations for other reasons did not occur, while the cumulative incidence gives systematically lower estimates. The Kaplan-Meier estimates are more appropriate when estimating the effectiveness of a contraceptive method, but the cumulative incidence estimates are more appropriate when making programmatic decisions regarding contraceptive methods. Other areas of application, such as cancer studies, may prefer to use the cumulative incidence estimates, but their use should be determined according to the application.

Computer Simulation↗
PubMed1998

Adolescent contraception.

Adolescent pregnancy rates have declined modestly, most likely because of the increased use of condoms, especially at first intercourse. Condom distribution in schools appears to be effective in promoting condom use without increasing sexual activity. Although, to date, no contraceptive has been as effective as Norplant in reducing teen pregnancy, use of the method has declined dramatically. Depo-Provera use is increasing, but continuation rates are disappointing and the impact on teen pregnancy rates is as yet unknown. Emergency contraception remains underutilized, and interventions to improve oral contraceptive compliance are beginning to be explored. School-based programs that provide contraception without adding a strong educational component fail to improve contraceptive use or reduce pregnancy rates. Use of any contraceptive by teens is cost effective.

Adolescent↗
PubMed2006

Efficacy and safety of a low-dose 21-day combined oral contraceptive containing ethinylestradiol 20microg and drospirenone 3mg.

OBJECTIVE: The purpose of this study was to assess the efficacy and safety of a new low-dose oral contraceptive containing ethinylestradiol 20microg and drospirenone 3mg (EE 20microg/drsp 3mg). METHODS: This was an open-label, non-comparative, multicentre study conducted at 33 centres in Germany and Switzerland. The combined contraceptive was administered over 26 cycles of treatment, with each cycle consisting of once-daily treatment for 21 consecutive days followed by a 7-day hormone-free interval. RESULTS: A total of 527 women were randomised, of whom 516 (97.9%) started treatment and had at least one study observation. Two pregnancies occurred during 11 165 cycles of treatment, giving a Pearl Index of 0.23 (upper limit of 97.5% CI 0.84). The corresponding 2-year cumulative pregnancy rate was 0.44% (95% CIs 0, 1.05). One of the two pregnancies was attributed to non-compliance with treatment, giving an adjusted Pearl Index of 0.12 (upper limit of 97.5% CI 0.67) over 10 827 compliant cycles. Only three (0.6%) women discontinued treatment because of bleeding problems in this long-term study, suggesting an acceptable bleeding profile. Overall, the study drug was well tolerated and adverse events experienced were typical of hormonal contraceptive use. The majority of women who responded (435 of 501; 86.8%) were satisfied or very satisfied with the study treatment and most (367 of 501; 73.3%) would continue with it if given the choice. CONCLUSION: The EE 20microg/drsp 3 mg combined oral contraceptive is an effective and well tolerated contraceptive with an acceptable bleeding pattern.

Adolescent↗