Contraceptive Ring Research Articles

Influence of hormonal contraceptives and the occurrence of stroke: integrative review.

To identify scientific evidence regarding the influence of hormonal contraceptive use and the occurrence of stroke. Integrative review of the literature, through database search using the descriptors "contraceptive agents", "contraceptive devices", "contraceptives, Oral" and "Stroke". Original studies in Portuguese, Spanish and English, published in full and available online were included. Studies that did not answer our guiding questions and duplicated studies were excluded. Women using combined oral contraceptives have higher risk of stroke, even with a lower hormonal dosage and different types of progestogen, regardless of the duration of use. The use of contraceptives associated with smoking, hypertension, migraine, hypercholesterolemia, obesity and sedentary lifestyle increases the chance of stroke. Contraceptive patch and vaginal ring are associated to increased risk. Use of combined hormonal contraceptives, except for the injectable and the transdermal ones, increases the chance of occurrence of the event. Progestogen-only contraceptives were considered safe. Identificar evidências científicas acerca da influência do uso de anticoncepcionais hormonais na ocorrência do acidente vascular cerebral (AVC). Revisão integrativa da literatura, com pesquisa em bases de dados, utilizando os descritores "contraceptive agents", "contraceptive devices", "contraceptives, Oral" e "stroke". Foram incluídos artigos originais nos idiomas português, espanhol e inglês, publicados na íntegra e disponíveis eletronicamente. Foram excluídos artigos que não respondiam às questões norteadoras e repetidos. Usuárias de anticoncepcional oral combinado apresentam risco maior de AVC, mesmo com dosagem hormonal menor e diferentes tipos de progestágeno, independente do tempo de uso. A presença associada de tabagismo, hipertensão arterial, enxaqueca, hipercolesterolemia, obesidade e sedentarismo aumenta a chance desse desfecho. Adesivo anticoncepcional e anel vaginal são relacionados ao aumento desse risco. A exposição aos anticoncepcionais hormonais combinados aumenta a chance de ocorrência do evento, exceto o injetável e o transdérmico. Os exclusivos de progestágeno foram considerados seguros.

Informed consent, community engagement, and study participation at a research site in Kigali, Rwanda.

People enroll in medical research for many reasons ranging from decisions regarding their own or family members' health situation to broader considerations including access to health and financial resources. In socially vulnerable communities the choice to participate is often based on a risk-benefit assessment that goes beyond the medical aspects of the research, and considers the benefits received. In this qualitative study, we examined the motivations of Rwandan women to participate in a non-commercial collaborative research study examining the safety, acceptability, and adherence of a contraceptive vaginal ring in Rwanda juxtaposed with the perceptions of the research within the community. 351 women attended the screening visit, four were excluded because they were not able to complete the assessment of understanding. The remaining participants' ages ranged from 17 to 38 and 80% had primary level of education or below. 120 were enrolled. Findings highlighted motivations for joining the study that were relayed both formally by the clinic (e.g. testing and treatment) and informally by the community including the positive aspects of the ring. There were also some negative rumors circulating regarding the research site, likely from excluded participants who faced potential stigma based on that exclusion. It was understood by most participants that they were enrolled in a research study and participants actively sought out enrollment in the research for a variety of reasons. The experiences demonstrate that although inequalities in access to health care may create conflicting situations around the study, it is possible to form partnerships between a research center and participants/their partners, for research about reproductive health.

Contraceptive Vaginal Ring and Female Sexual Function in Kigali, Rwanda

Sexual satisfaction may influence acceptability and adherence of contraceptive methods, in particular contraceptive vaginal rings (CVR) which are likely to affect sexual relationship. This study aimed to assess female sexual function (FSF) among women using CVRs in Rwanda. Women participating in a CVR clinical trial in Kigali, Rwanda. Mixed-methods were used to assess acceptability and adherence of a CVR (Nuvaring®) in this two arm trial, comparing women with intermittent and extended ring use. FSF was assessed in both arms before and after CVR use. A 6-Item Version of the Female Sexual Function Index (FSFI-6) was administered to measure FSF, assessing for each item optimal function (maximum 5) to poor function (minimum 1). Triangulation of qualitative and quantitative data indicated high acceptability of and adherence to the Nuvaring®. Of a total of 120 women enrolled, ten reported a low baseline FSF score (≤ 19). At the last study visit, 95 women (79.2%) had a high FSF score between 25-30, 23 (19.2%) a moderate score between 20-24 and only two women (1.6%) reported a score ≤ 19. Compared to baseline FSF scores (total mean 24.2 ±3SD), end of study visit scores (total mean 26.5 ± 2.5SD) showed an improved sexual function (p<0.05). A significant improvement between baseline and last visit was seen when looking at all 6 items individually. We did not find a significant difference in improved sexual function between intermittent and extended users. (Inter)personal factors such as the quality of the relationship and the effects on sexual pleasure had an impact on overall acceptability and adherence of the CVR.

Youtube Series Support Dutch Girls in Choosing a Contraceptive Method

Soa Aids Nederland (SANL) and Rutgers invite Dutch teenage girls to share their experiences on contraceptive use and to learn from each other. Using a blend of social media this is done through Britt Talk; six short films including a call for action. Research results in the Netherlands showed that Dutch girls need more knowledge and positive attitudes to make informed and healthy decisions regarding use of contraceptives. In this process, many girls rely on experiences of their peers. Last December the series of 6 films was launched on Sense.info. This is the most visited website on sexual health for young people aged 12–15 in the Netherlands. SANL and Rutgers partner in moderating this site. In six different episodes Britt Talk discusses the contraceptive pill, plaster injection and ring, the IUD and Implanon. Each episode is hosted by Britt Scholte – a popular Dutch female moderator on YouTube (116,000 followers) – and another female YouTube celebrity. All hosts are between 17–21 years old.

Factors associated with psychological distress among young women in Kisumu, Kenya.

BackgroundAttention to mental health issues is growing globally. In many countries, including Kenya, however, assessment of psychological distress, especially in rural areas, is limited.MethodsWe analyzed data from young women screened for a longitudinal contraceptive ring study in Kisumu, Kenya. Multivariable regression analysis was used to assess factors associated with recent moderate and high psychological distress, as measured by the Kessler (K-6) psychological distress scale.ResultsAmong the 461 women screened, most (58.4%) were categorized as having moderate psychological distress, 20.8% were categorized as having low or no psychological distress, and 20.8% were categorized as having high psychological distress. Moderate psychological distress (vs low/no) was significantly more likely among women who reported a history of forced sex and were concerned about recent food insecurity. High (vs low/no) psychological distress was significantly more likely among women who reported a history of forced sex, who were concerned about recent food insecurity, and who self-reported a sexually transmitted infection.ConclusionTo reduce psychological distress, a focus on prevention as well as care methods is needed. Girls need a path toward a healthy and productive adulthood with a focus on education, which would help them gain skills to avoid forced sex. Women would benefit from easy access to social services and supports that would help them with basic needs like food security among other things. A holistic or ecological approach to services that would address mental, educational, social, health, and economic issues may have the highest chance of having a long-term positive impact on public health.

Weight gain, body image and sexual function in young patients treated with contraceptive vaginal ring. A prospective pilot study

Introduction: Oral contraceptives could induce mood changes. As far as our knowledge, there are no studies in literature that have examined the role of vaginal contraception in self-perceived body image.Aim: To evaluate the effects of intravaginal contraception on weight gain and perceived body image in relation with the Beck’s Depression Inventory questionnaire (BDI) and the McCoy Female Sexuality Questionnaire (MFSQ).Methods: Twenty-one adult (18–35 years old) eumenorrheic (menstrual cycle of 25–35 days), lean (body mass index – BMI – of 19–25 kg/m2) women who were referred for hormonal contraception were administered the Stunkard Figure Rating Scale (FRS), BDI and MFSQ. Subjects were studied in basal condition and after 6 months of therapy with vaginal contraception (NuvaRing®; Organon-Schering-Plough Italia, Milan, Italy).Main outcome measures: BMI, FRS, MFSQ and BDI.Results: After 6 months of therapy with NuvaRing®, both body weight (60.0 ± 8.3; p = 0.050) and BMI (22.1 ± 3.1; p = 0.028) slightly, but statistically, increased. FRS and BDI showed no differences after the vaginal contraception. Hormonal contraception was associated with a significant decrease in the two-factor Italian MFSQ score.Conclusions: Vaginal ring seems a good alternative to other hormonal contraceptive not significantly altering the female sexuality and not influencing the FRS and BDI.

Residual hormone levels in used contraceptive rings as a measurement of adherence to vaginal ring use

ObjectiveThis study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials. Study designResidual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice. ResultsTwenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones. ConclusionResidual vaginal ring drug levels could help assess adherence in clinical trials.

Efficacy and side-effects profile of the ethinylestradiol and etonogestrel contraceptive vaginal ring: a systematic review and meta-analysis

Objective: To assess the efficacy and tolerability (side-effects profile), and compliance of the combined contraceptive vaginal ring (CCVR) compared with combined oral hormonal contraceptives (COC). Data sources: The PubMed, Embase, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, ClinicalTrials.gov, Clinical Trials Registry Platform (ICTRP) and CINAHL databases were searched. Methods of study selection: Electronic databases were searched for randomised clinical trials comparing the CCVR with COC with a duration of at least 3 months between 01 December and 15 December 2015. The primary outcome was efficacy. The secondary outcomes were compliance, absence of withdrawal bleeding, breakthrough bleeding, nausea and headache. Heterogeneity was assessed using I 2 statistic and Cochran's Q statistic. Results were expressed as odds ratios (OR) with 95% confidence intervals (CIs) using random-effects models or fixed-effects models depending on the heterogeneity. Results: 4368 records were identified, 2844 of which were removed after duplicates and 1524 records were screened. Of these, 1503 were excluded and 21 full text articles were assessed for eligibility. After removing another 7 articles, 14 records were finally included in the qualitative and quantitative analysis. The results show a trend to higher efficacy for the CCVR in preventing pregnancy (Peto OR: 0.52 [95% CI: 0.26–1.04]) and a significantly lower presence of nausea (Peto OR: 0.66 [95% CI: 0.46–0.93]). More cycles were compliant in the CCVR group (Peto OR: 1.22 [95% CI: 1.12–1.32]) and fewer women reported breakthrough bleeding (Peto OR: 0.68 [95% CI: 0.51–0.91]). Conclusions: Our findings demonstrate that the CCVR is as effective and tolerable as the COC but with a better bleeding profile.

CHANGES IN VAGINAL PRACTICES AFTER CONTRACEPTIVE VAGINAL RING USE AMONG WOMEN IN KIGALI, RWANDA

BackgroundRecent developments in HIV prevention, including the dapivirine vaginal ring, have shown promising results in protecting women from HIV. Additionally, a healthy vagina is protective against HIV/STIs but vaginal practices...

Implications of dispensing self-administered hormonal contraceptives in a 1-year supply: a California case study

On September 23, 2016, California became the sixth state to pass legislation requiring health plans and insurers to cover a 12-month supply of FDA-approved self-administered hormonal contraceptives such as contraceptive pills, patches and vaginal rings. This legislation is estimated to result in 38% of current contraceptive pill, patch, and ring users receiving a 12-month supply dispensed at one time. This shift in dispensing patterns was estimated to result in a reduction of 15,000 unintended pregnancies; 2000 fewer miscarriages; and 7000 fewer abortions in California decreasing total net health care expenditures by 0.03%. With similar legislation introduced in 17 states, the findings from this study are important for consideration outside of California.

Contraceptive vaginal ring experiences among women and men in Kisumu, Kenya: A qualitative study.

Future HIV prevention options for women will likely include Antiretroviral (ARV)-based intravaginal rings. Valuable insights may be gained by examining user experiences with a similar licensed technology, a contraceptive ring, especially in settings where this technology may not be currently available. In-depth interviews with 24 females enrolled in a trial assessing acceptability and use of a contraceptive ring, and 20 male sexual partners were conducted September 2014-April 2015. Elements of ethnography and phenomenological anthropology were used to collect, analyze, interpret, and describe ring users' experiences. Thematic analysis was completed in MaxQDA-10. Experiences with the contraceptive ring reflected a broader Family Planning (FP) paradigm that centered around three themes: latitudes and drawbacks of FP (being free); an FP method needs to be compatible with a woman's body (feeling normal); and dealing with fertility control uncertainties (how well does it really work). FP intentions and disclosure practices were influenced by partner support, socioeconomic factors, religion, cultural beliefs, and societal norms, including female sexuality. A user-friendly FP design was emphasized. Non-suppression of menstruation was favored by most. Unease with vaginal insertion as well as ring placement issues (slippage, expulsion) created initial challenges requiring clinician assistance and practice for some participants. While minor side-effects were described, concerns centered on ring efficacy, negative effect on a woman's sexual desire, and future fertility issues. Awareness of the multiple contexts in ring users' experience may inform the development, education, and promotion approaches for future ARV rings.

Stroke and Etonogestrel/Ethinyl Estradiol Ring (NuvaRing): Clinical, Radiological, and Prognostic Features

A recent study found that NuvaRing (a vaginal contraceptive ring containing 15 µg ethinyl estradiol and 120 µg etonogestrel) has 2.5 times increased relative risk of thrombotic stroke compared to nonuse. We studied a case series of 19 such patients as well as prior published case reports to clarify clinical, radiological, and prognostic features. Medical records and imaging for 18 cases were initially systematically reviewed for consultation in a class action lawsuit. One case was seen personally outside of litigation. All 19 cases were entered into a database detailing clinical, radiological, and prognostic features as well as other potential risk factors. A literature search identified 8 additional cases. Average age at stroke was 31.7 ± 9.8 years; average duration of NuvaRing use prior to stroke was 11.2 months. Arterial stroke occurred in 10 of 19 (52%); 1 of 10 (10%) was hemorrhagic. Venous sinus thrombosis was present in 11 of 19 (58%) on initial imaging; 6 of 11 (54%) were hemorrhagic. The most common presenting symptom was headache (7 of 19 [37%]) and motor weakness (7 of 19 [37%]). A hypercoagulable condition was present in 3 of 19 (16%); 3 of 19 (16%) had history of hypercoagulable disease in a first-degree relative. Mortality was .5%; 8 of 19 (42%) fully recovered and 3 of 19 (15%) were discharged to rehabilitation. In this largest case series of NuvaRing-associated stroke to date, approximately half of the strokes are venous and half are arterial. Stroke typically occurred within the first year of use, and as soon as 2 weeks after NuvaRing initiation.

Comparison of combined hormonal vaginal ring and low dose combined oral hormonal pill for the treatment of idiopathic chronic pelvic pain: a randomised trial

ObjectiveTo compare the efficacy and acceptability of combined hormonal vaginal ring with combined oral hormonal pill in women with idiopathic chronic pelvic pain. Study designRandomised prospective interventional trial conducted in 60 women with idiopathic chronic pelvic pain. Women were randomised into two groups of 30 each. In each group, treatment was given for 84 days using either combined vaginal ring or combined oral hormonal pill. Hormonal vaginal ring releases 15mcg of ethinyl estradiol and 120mcg of the etonogestrel per day while the hormonal pill contained 30mcg of ethinyl estradiol and 150mcg of levonorgestrel. There was no ring or pill free week. After every 28 days, pain relief was measured using visual analogue scale (VAS), and verbal rating score (VRS) calculated by summing dysmenorrhea, non-cyclic pelvic pain (NCCP) and deep dyspareunia scores. Side effects, compliance, satisfaction, and user acceptability were also measured. Data was analyzed using various parametric and non-parametric tests. ResultsReduction in mean VAS score at end of treatment in ring group was 6.23 (95% confidence interval [CI], 5.45–7.01; p<0.001) as compared to 5.53 in pill group (95% CI, 4.83–6.23; p<0.001). Reduction in mean VRS score was 5.63 in ring users (95% CI, 4.84–6.42; p<0.001) versus 4.36 in pill users (95% CI, 3.63–5.10; p<0.001). A significantly higher persistent relief in NCPP score was observed in vaginal ring group as compared to oral pill group at end of one month after stopping treatment. Compliance, satisfaction, and user acceptability were higher in ring users (80%) than pill users (70%) and a higher incidence of nausea was seen in pill group. ConclusionPresent study demonstrates for first time that both vaginal and oral hormonal therapy are effective in treatment of idiopathic chronic pelvic pain and vaginal ring may be a better choice with higher satisfaction rate and fewer side effects.

Acceptability, tolerability, and satisfaction of a contraceptive vaginal ring (the NuvaRing) among Thai women

Background: The NuvaRing has demonstrated efficacy and acceptability in a number of clinical studies mostly in western countries. Because of cultural differences and self-administration of the device, it may not be wellaccepted by Thai women. Objectives: To assess the acceptability, tolerability and satisfaction of Thai women who started to use the NuvaRing. Methods: The levels of acceptance by 39 clients who began using the NuvaRing were reviewed in this retrospective observational cohort study of clients at a family planning clinic in Bangkok. Ring-related and other adverse events were recorded at the end of second, fourth, and sixth cycles. Results: Included in this study were clients (38/39; 97%) who used the NuvaRing for six cycles consecutively. Difficulties in removing the NuvaRing were experienced by 13% of the participants and 49% felt transient vaginal discomfort; however, these problems resolved over time. Approximately one third of clients had asymptomatic watery discharges. Of the total of 229 cycles 95.1% were as usual with scheduled bleeding. Seventy-one percent of the clients were very satisfied. Before and after 6 cycles of using the NuvaRing, there were no significant clinical differences between body weight, blood pressure, duration of period, and amount of pads used per cycle found using paired 2-sample t tests. Conclusions: NuvaRing has demonstrated no significant effects on regular cycle continuation and had very few clients experienced adverse events. The acceptability of this device and satisfaction of using it were partly owing to structural, comprehensive counseling, and support provided by the family planning staff. Keywords: Acceptability, contraceptive vaginal ring, NuvaRing, satisfaction, tolerability

Early Impact of the Affordable Care Act on Uptake of Long-acting Reversible Contraceptive Methods.

The Affordable Care Act (ACA) required most private insurance plans to cover contraceptive services without patient cost-sharing as of January 2013 for most plans. Whether the ACA's mandate has impacted long-acting reversible contraceptives (LARC) use is unknown. The aim of this article is to assess trends in LARC cost-sharing and uptake before and one year after implementation of the ACA's contraceptive mandate. A retrospective cohort study using Truven Health MarketScan claims data from January 2010 to December 2013. Women aged 18-45 years with continuous insurance coverage with claims for oral contraceptive pills, patches, rings, injections, or LARC during 2010-2013 (N=3,794,793). Descriptive statistics were used to assess trends in LARC cost-sharing and uptake from 2010 through 2013. Interrupted time series models were used to assess the association of time, ACA, and time after the ACA on LARC cost-sharing and initiation rates, adjusting for patient and plan characteristics. The proportion of claims with $0 cost-sharing for intrauterine devices and implants, respectively, rose from 36.6% and 9.3% in 2010 to 87.6% and 80.5% in 2013. The ACA was associated with a significant increase in these proportions and in their rate of increase (level and slope change both P<0.001). LARC uptake increased over time with no significant change in level of LARC use after ACA implementation in January 2013 (P=0.44) and a slightly slower rate of growth post-ACA than previously reported (β coefficient for trend, -0.004; P<0.001). The ACA has significantly decreased LARC cost-sharing, but during its first year had not yet increased LARC initiation rates.

Prevalence of combined contraceptive vaginal rings in Norway.

Little is known about vaginal ring (VR) prescribers and user patterns in Norway and internationally. With data from the Norwegian Prescription Database, we explore user and prescriber characteristics of women initiating VR use. In a cross-sectional study design, we analyzed 47127 first-time VR users from 1 January 2006 to 31 December 2012. Follow up ended on 30 June 2013. We applied strict definitions for switching from any other hormonal contraceptive before and at the end of VR use. All analyses were performed using SPSS, with chi-squared test, t-test, and survival analysis. At study end, the prevalent use of VR reached 10 per 1000 women of fertile age, which amounted to 3% of all hormonal contraceptive use. The number of first-time VR users increased from 2006 to 2008 only among women under the age of 20. Nearly three out of four new users discontinued after 3months. Physicians without specialist status and general practitioners accounted for over 70% of the prescriptions, whereas gynecologists accounted for 17% of the prescriptions. Gynecologists were significant prescribers of VR to women aged 35 or more. Gynecologists are important providers of VR to first-time users above 30years of age. When prescribing VR to first-time users, it is important to discuss the need for contraception in a longer time perspective. Authorizing public health nurses/midwives as VR prescribers to teenagers, from 1 March 2006, may explain the relative increase in VR usage at a younger age.

Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial

Objectives: The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15 μg ethinylestradiol [EE] and 120 μg etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30 μg EE and 3 mg drospirenone in healthy Chinese women aged 18–40 years.Methods: This was a phase III, open-label, randomised multicentre trial conducted in China. Participants received NuvaRing or COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-free/pill-free period). Contraceptive efficacy was assessed by in-treatment pregnancies and expressed by the Pearl Index (PI; number of pregnancies/100 woman-years of use). Cycle control was assessed by unscheduled (breakthrough) and absence of scheduled (withdrawal) bleeding events. Safety and tolerability were assessed throughout the study.Results: Participants were randomised either to the NuvaRing (n = 732) or to the COC (n = 214); 588 (82.4%) and 182 (78.4%) participants, respectively, completed the study. There were 10 in-treatment pregnancies in the NuvaRing group (PI 1.92; 95% confidence interval [CI] 0.92, 3.53) and five in the COC group (PI 3.12; 95% CI 1.01, 7.29). Breakthrough bleeding/spotting ranged from 18.6% (Cycle 1) to 4.2% (Cycle 11) for NuvaRing and from 21.6% (Cycle 1) to 7.9% (Cycle 11) for COC. Absence of withdrawal bleeding ranged from 8.6% (Cycle 1) to 3.0% (Cycle 11) for NuvaRing and from 14.6% (Cycle 1) to 6.4% (Cycle 5) for COC. For NuvaRing and COC, respectively, 26.6% and 25.0% of participants had treatment-related adverse events, and 7.0% and 9.1% discontinued the study as a result.Conclusions: Once-monthly NuvaRing is efficacious and safe for use in Chinese women.

Efficacy of combined hormonal vaginal ring in comparison to combined hormonal pills in heavy menstrual bleeding

ObjectiveTo compare the efficacy, acceptability and compliance of combined hormonal vaginal ring (CVR), with combined hormonal pills (CHP) in patients with heavy menstrual bleeding (HMB). Study designThis prospective study was conducted in 50 women with HMB in age group of 25–40 years. Patients were divided in two groups of 25 each and followed for six treatment cycles. In each group, cycle comprised of three weeks of CVR (releases 15μg of EE and 120μg of the etonogestrel per day) or CHP (containing 30μgm of EE and 150μgm of LNG) use, followed by one ring or pill free week. After each cycle, patients were evaluated about the amount of blood loss and duration of bleeding by the pictoral blood assessment chart (PBAC), early bleeding (EWB), continued bleeding (CWB), intermenstrual bleeding, intended bleeding, compliance, and user acceptability. The collected data were analyzed using the Chi square test, t-test and ANOVA test. ResultReduction in PBAC score for CVR (70.73%) and CHP group (70.02%), duration of bleeding and incidence of EWB was comparable among the two groups. The incidence of intermenstrual bleeding was lower in CVR than in CHP group in cycle 3 and 4 with significant p value. The incidence of CWB was significantly lower and the incidence of intended bleeding pattern in CVR group was significantly higher in cycle 3, 4, 5 and 6, signifying better cycle control. Compliance was also higher in CVR (88%) than CHC (75.33% of all cycles). ConclusionThis trial suggests that both the CVR and CHP are very effective short-term treatments for HMB in reproductive age group. However, women had better cycle control and compliance with CVR. This may be an attractive option among the wide variety of medications used to treat HMB.

An Open-Label, Randomized, Two-Period Crossover Study of the NuvaRing Applicator in Healthy Women [8N

INTRODUCTION: NuvaRing®, a contraceptive vaginal ring, is inserted by the user with her fingers. An applicator has been developed as an optional insertion aid. This study assessed performance, tolerability, and safety of a new applicator. METHODS: Women aged 18–45 years not currently using NuvaRing® were enrolled at 2 centers in this 2-period crossover study. Women were randomly assigned to either applicator or fingers in the first period and the other method in the second. For both periods, the ring was in place for 24–72 h; questionnaires were administered immediately following ring insertion and at removal. The second period occurred 48–72 h after removal of the first ring. RESULTS: 164 women (mean age 30.2 years) were randomized: 163 completed the applicator period, 162 completed the fingers period. Insertion was 100% successful with both methods. Ring expulsion occurred in 1 and 2 women, respectively, with applicator and fingers. Among randomized subjects, 8.6% and 4.3%, respectively, reported at least 1 treatment-related adverse event (AE); all were mild and were mostly considered related to the ring rather than the insertion method. Five AEs (4 events [2.5%] of vulvovaginal pain, 1 episode [0.6%] of abdominal cramping) were considered related to the applicator. The 4 AEs of mild pain (eg, “pinching”) lasted less than 1 minute and resolved spontaneously. Bleeding did not occur during or up to 15 h following applicator use; mild events occurred more commonly during follow-up after applicator use (3.1% and 0.6%, respectively). CONCLUSION: The NuvaRing® Applicator is an effective and well-tolerated optional NuvaRing® insertion aid.

Long-Acting Reversible Contraception and Condom Use Among Female US High School Students: Implications for Sexually Transmitted Infection Prevention.

Long-acting reversible contraception (LARC), specifically intrauterine devices and implants, offers an unprecedented opportunity to reduce unintended pregnancies among adolescents because it is highly effective even with typical use. However, adolescent LARC users may be less likely to use condoms for preventing sexually transmitted infections compared with users of moderately effective contraceptive methods (ie, oral, Depo-Provera injection, patch, and ring contraceptives). To compare condom use between sexually active female LARC users and users of moderately effective contraceptive methods. Cross-sectional analysis using data from the 2013 national Youth Risk Behavior Survey, a nationally representative sample of US high school students in grades 9 through 12. Descriptive analyses were conducted among sexually active female students (n = 2288); logistic regression analyses were restricted to sexually active female users of LARC and moderately effective contraception (n = 619). The analyses were conducted in July and August 2015. Contraceptive method at last sexual intercourse was assessed by 1 item-respondents could select birth control pills; condoms; an intrauterine device or implant; injection, patch, or ring; withdrawal or other method; or not sure. A separate item asked whether respondents used a condom at last sexual intercourse. We created an indicator variable to distinguish those reporting use of (1) LARC (intrauterine device or implant), (2) oral contraceptives, and (3) Depo-Provera, patch, or ring. Among the 2288 sexually active female participants (56.7% white; 33.6% in 12th grade), 1.8% used LARC; 5.7% used Depo-Provera, patch, or ring; 22.4% used oral contraceptives; 40.8% used condoms; 11.8% used withdrawal or other method; 15.7% used no contraceptive method; and 1.9% were not sure. In adjusted analyses, LARC users were about 60% less likely to use condoms compared with oral contraceptive users (adjusted prevalence ratio [aPR], 0.42; 95% CI, 0.21-0.84). No significant differences in condom use were observed between LARC users and Depo-Provera injection, patch, or ring users (aPR, 0.57; 95% CI, 0.26-1.25). The LARC users were more than twice as likely to have 2 or more recent sexual partners compared with oral contraceptive users (aPR, 2.61; 95% CI, 1.75-3.90) and Depo-Provera, patch, or ring users (aPR, 2.58; 95% CI, 1.17-5.67). Observed differences in condom use may reflect motivations to use condoms for backup pregnancy prevention. Users of highly effective LARC methods may no longer perceive a need for condoms even if they have multiple sexual partners, which places them at risk for sexually transmitted infections. As uptake of LARC increases among adolescents, a clear need exists to incorporate messages about condom use specifically for sexually transmitted infection prevention.