Contraception use and changes in young women with newly diagnosed breast cancer.

OBJECTIVE: To evaluate contraception use and change among young women with early breast cancer. DESIGN: Secondary analysis of a cluster randomized trial. SETTING: Multi-institutional. PATIENT(S): Patients with newly diagnosed breast cancer age ≤45 years enrolled from 54 US oncology practices. INTERVENTION(S): Sites were randomly assigned to the Young Women's Intervention, an educational intervention for young women with newly diagnosed breast cancer and their oncologists addressing issues specific to this population, including contraception, or a contact-time control physical activity intervention. Participants completed surveys in follow-up, including a 3-month survey regarding contraceptive practices before and after diagnosis. MAIN OUTCOME MEASURE(S): Outcomes of interest included young women's contraceptive use and methods before breast cancer diagnosis and 3 months after study enrollment. Logistic regression models assessed factors associated with use of less than highly effective contraceptive methods categorized according to World Health Organization effectiveness tiers and changes in contraceptive methods. RESULT(S): Of 312 women included, 258 (83%) reported contraceptive use before breast cancer diagnosis, and 275 (88%) reported contraceptive use after diagnosis. Use of highly effective methods (e.g., vasectomy, non-hormonal intrauterine devices) increased from 39% before diagnosis to 52% after diagnosis. Use of moderately effective methods (e.g., hormonal methods) decreased from 22% before diagnosis to 3% after diagnosis. Use of less effective methods (e.g., condoms, withdrawal) increased from 22% before diagnosis to 34% after diagnosis. On multivariable analysis, factors associated with using less than highly effective contraception after diagnosis included desire for additional children (odds ratio [OR], 6.33; 95% confidence interval [CI], 3.76-10.66) and discussing contraception with a provider (OR, 1.96; 95% CI, 1.12-3.40). After breast cancer diagnosis, 207 patients (66%) reported no change in contraceptive methods. On multivariable analysis, factors associated with contraceptive method change after diagnosis included age <35 years (OR, 2.96; 95% CI, 1.57-5.58) and provider discussion (OR, 3.59; 95% CI, 1.91-6.78). There was no association in either analysis with study arm. CONCLUSION(S): Although most patients used contraception after breast cancer diagnosis, nearly half reported using less than highly effective contraceptive methods with higher failure rates, highlighting the need for early and improved contraceptive counseling for young women with breast cancer. CLINICAL TRIAL REGISTRATION NUMBER: NCT01647607.

Contraceptive efficacy: Determining the threshold for effective suppression based on sperm concentration, motility, and morphology.

INTRODCTION: Human spermatogenesis is a complex process that transforms spermatogonial stem cells through mitosis and meiosis to spermatozoa. Testosterone is the key regulator of the terminal stages of meiosis, adherence of spermatids to Sertoli cells, and spermiation. Follicle-stimulating hormone (FSH) may be required for early spermatogenesis and is important for maintaining normal spermatogenesis in men. Hormonal contraception suppresses FSH, luteinizing hormone, and intratesticular testosterone concentration, resulting in marked suppression of sperm output. RESULTS: Clinical trials using testosterone alone or testosterone plus progestin demonstrate that sustained suppression of sperm concentration to ≤1 million/mL is sufficient to prevent pregnancy in the female partner. New agents that target spermatogenesis could use this as a target for contraceptive efficacy while others that block sperm function or transport may require a lower threshold. When sperm concentrations are suppressed to such low levels, measurement of sperm motility and morphology is technically difficult and unnecessary. With current data from fertile and infertile men, it is not possible to establish a lower limit of sperm motility or percent normal morphology that equates to the prevention of conception. New compounds that decrease sperm motility or alter sperm morphology may need to demonstrate a complete absence of sperm motility or altered morphology in all spermatozoa in the ejaculate. Sperm function tests may be useful depending on the mechanism of action of each new compound. CONCLUSION: Monitoring of sperm surrogate markers to ensure effective contraception relies on laboratories experienced in semen analyses. The development of at-home tests to assess sperm parameters has progressed rapidly. Some tests have been assessed in clinical trials and approved by regulatory agencies for at-home use for fertility assessment. However, caution must be exercised in using these tests as many have not been rigorously validated against semen parameters measured in laboratories by trained technologists using standardized tests defined in the World Health Organization Semen Manual.

Perception of women on safety and efficacy of contraceptives: A comparative study.

Background: Contraceptive information and services are fundamental to the health and human rights of all individuals. Low contraceptive use is a major challenge faced in India. To determine whether a lack of awareness of contraceptive methods was a factor, we assessed the perception of women on contraceptive methods, their safety and efficacy and further determined whether their demographic background played any role in their perception. Materials and Methods: Reproductive-aged women from both rural and urban backgrounds of Bangalore and Tumkur, Karnataka, were individually questioned in a community setting using both Google Forms and personal interviews from September 2022 to December 2022. The questions consisted of limited demographic information and specific questions related to the knowledge and beliefs of women on the efficacy and safety of contraceptive methods and assessed situational awareness. Results: Although awareness was more amongst urban women (99.1%) compared with rural women (79%), the practice was significantly higher amongst rural women (63.2%) compared with urban women (36.7%). Perception showed variations with respect to age, education, religion and parity. A major religion-wise disparity was observed. With regard to safety, oral contraceptive pills (60.9%) and condoms (51.8%) were unanimously perceived to be the most and least harmful to health. The most commonly perceived short-term complications were found to be body changes, and mood swings, tiredness and infertility with no data to support the claim were the most commonly chosen long-term complication. Conclusion: From the study, we concluded that more educated women were not immune to misinformation. The efficacy rates of different methods were highly underestimated with methods with higher failure rates perceived to be more effective. Results demonstrate that women are ill-informed about the long-term complications of various methods.

Practice and development of male contraception: European Academy of Andrology and American Society of Andrology guidelines.

BACKGROUNDS: Despite a wide spectrum of contraceptive methods for women, the unintended pregnancy rate remains high (45% in the US), with 50% resulting in abortion. Currently, 20% of global contraceptive use is male-directed, with a wide variation among countries due to limited availability and lack of efficacy. Worldwide studies indicate that >50% of men would opt to use a reversible method, and 90% of women would rely on their partner to use a contraceptive. Additional reasons for novel male contraceptive methods to be available include the increased life expectancy, sharing the reproductive risks among partners, social issues, the lack of pharma industry involvement and the lack of opinion makers advocating for male contraception. AIM: The present guidelines aim to review the status regarding male contraception, the current state of the art to support the clinical practice, recommend minimal requirements for new male contraceptive development and provide and grade updated, evidence-based recommendations from the European Society of Andrology (EAA) and the American Society of Andrology (ASA). METHODS: An expert panel of academicians appointed by the EAA and the ASA generated a consensus guideline according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. RESULTS: Sixty evidence-based and graded recommendations were produced on couple-centered communication, behaviors, barrier methods, semen analysis and contraceptive efficacy, physical agents, surgical methods, actions before initiating male contraception, hormonal methods, non-hormonal methods, vaccines, and social and ethical considerations. CONCLUSION: As gender roles transform and gender equity is established in relationships, the male contribution to family planning must be facilitated. Efficient and safe male-directed methods must be evaluated and introduced into clinical practice, preferably reversible, either hormonal or non-hormonal. From a future perspective, identifying new hormonal combinations, suitable testicular targets, and emerging vas occlusion methods will produce novel molecules and products for male contraception.

Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial.

BACKGROUND: The 52-mg levonorgestrel-releasing intrauterine system is an established, long-acting contraceptive option with approved use for up to 7 years. OBJECTIVE: The Mirena Extension Trial evaluated the efficacy and safety of the 52-mg levonorgestrel-releasing intrauterine system during extended use beyond 5 and up to 8 years. STUDY DESIGN: This was a multicenter, single-arm study in the United States, enrolling existing users of the 52-mg levonorgestrel-releasing intrauterine system, aged 18 to 35 years, who have had the system for 4.5 to 5 years. We assessed the contraceptive efficacy (Pearl Index) and cumulative failure rate (using the Kaplan-Meier method) of the 52-mg levonorgestrel-releasing intrauterine system during extended use. We also evaluated bleeding outcomes and adverse events. RESULTS: Of the 362 participants starting year 6, 243 entered and 223 completed 8 years of 52-mg levonorgestrel-releasing intrauterine system use. Just more than half the participants were parous. The mean (standard deviation) age was 29.2 (±2.9) years, and all participants were aged ≤36 years at the end of year 8. Two pregnancies occurred, both with the device in situ. The year 6 pregnancy was of undetermined location and resolved spontaneously. The pregnancy in year 7 was ectopic and resolved with methotrexate treatment. In both cases, the 52-mg levonorgestrel-releasing intrauterine system was removed and the participants left the trial. For years 6 to 8, the 3-year Pearl Index (95% confidence interval) was 0.28 (0.03-1.00) with a 3-year cumulative failure rate of 0.68% (0.17-2.71). Pearl Indexes for years 6, 7, and 8 were 0.34 (0.01-1.88), 0.40 (0.01-2.25), and 0.00 (0.00-1.90), respectively. The 3-year (years 6-8) ectopic pregnancy Pearl Index was 0.14 (0.00-0.77). We found treatment-emergent adverse events in 249 of 362 participants (68.8%), with 65 (18.0%) events considered to be related to the 52-mg levonorgestrel-releasing intrauterine system. The discontinuation rate was 38.4% (139/362), most commonly because of desire for pregnancy (12.2%, 44/362). During extended use beyond 5 years and up to 8 years, participants reported a decrease in the mean number of bleeding or spotting days with approximately half of the women experiencing amenorrhea or infrequent bleeding. We did not enroll a sufficient number of women using the 52-mg levonorgestrel-releasing intrauterine system for contraception and heavy menstrual bleeding to assess extended use for that indication. At the end of year 8, most (98.7%, 220/223) of the participants who completed the study remained satisfied with the continued use of the 52-mg levonorgestrel-releasing intrauterine system. Of the 31 women who discontinued early because of desire for pregnancy with evaluable data for return-to-fertility analysis, 24 reported a posttreatment pregnancy within 1 year, giving a 12-month return-to-fertility rate of 77.4%. CONCLUSION: The 52-mg levonorgestrel-releasing intrauterine system, initially approved for 5 years, maintains high contraceptive efficacy, user satisfaction, and a favorable safety profile through 8 years of use. Participants reported 26 posttreatment pregnancies in total, of which 24 occurred in women who had discontinued the 52-mg levonorgestrel-releasing intrauterine system because of a desire for pregnancy. Of note, among women who elected to continue use through 8 years, bleeding patterns remained highly favorable. These findings support continued 52-mg levonorgestrel-releasing intrauterine system use for up to 8 years in women who wish to continue treatment.

Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials.

OBJECTIVE: To evaluate overall and subgroup efficacy of an estetrol (E4) 15 mg drospirenone (DRSP) 3 mg oral contraceptive in a 24/4-day regimen. STUDY DESIGN: We pooled efficacy outcomes from 2 pivotal phase 3 contraceptive trials with E4/DRSP conducted in the United States/Canada and Europe/Russia. We assessed Pearl Index (PI; pregnancies per 100 participant-years) and 13-cycle life-table pregnancy rates in at-risk cycles (confirmed intercourse and no other contraceptive use) among participants 16 to 35 years. We calculated PI by age and further subcategorization (contraceptive history and body mass index [BMI]). We performed multivariable analysis using Cox regression to assess impact of potential confounding factors. RESULTS: Analyses included 3027 participants, of whom 451 (14.9%) had a BMI ≥30 kg/m2. The pooled PI was 1.52 (95% confidence interval 1.04-2.16) and the 13-cycle life-table pregnancy rate was 1.28% (0.83%-1.73%). We calculated unadjusted pooled PI in participants 16 to 25 years and 26 to 35 years of 1.61 (0.94-2.57) and 1.43 (0.78-2.40), respectively; in new starters and switchers of 1.88 (1.09-3.00) and 1.24 (0.68-2.08), respectively; and by BMI <25 kg/m2, 25 to 29.9 kg/m2, and ≥30 kg/m2 of 1.14 (0.64-1.88), 2.19 (1.05-4.03), and 2.27 (0.83-4.94), respectively. In multivariable analysis, we found associations of prior pregnancy (hazard ratio [HR] 3.61[1.56-8.38]), Black race (HR 4.61[1.97-10.80]), age 16 to 25 years (HR 2.37[1.09-5.15]) and compliance <99% of expected pills (HR 4.21[2.04-8.66]) with conception. CONCLUSION: E4/DRSP is an effective oral contraceptive overall and across subgroups stratified by age, contraceptive history, and BMI. Other than compliance, predictors of contraceptive failure are nonmodifiable. IMPLICATIONS STATEMENT: Pooled results from two phase 3 trials demonstrate high contraceptive efficacy of the novel estetrol-drospirenone oral contraceptive. Several non-modifiable risk factors, including prior pregnancy, race, and age, are associated with higher pregnancy risk. Additional research is needed to better understand predictors of combined oral contraceptive failure.

A novel estetrol-containing combined oral contraceptive: European expert panel review.

PURPOSE: Despite considerable advances in recently developed combined oral contraceptives (COCs), resulting in lower rates of adverse events while maintaining contraceptive efficacy, there is interest in further innovation. MATERIALS AND METHODS: Estetrol (E4), a native oestrogen, and progestin drospirenone (DRSP) were combined in a new COC. A European expert panel reviewed the pharmacology, efficacy, and safety and tolerability of this combination. Their findings are presented as a narrative review. RESULTS: E4 15 mg/DRSP 3 mg in a 24/4 regimen provided effective contraception with good cycle control, characterised by a predictable regular bleeding pattern and minimal unscheduled bleeding, together with a good safety profile. The combination was associated with high user satisfaction, well-being, and minimal changes in body weight. The effects on endocrine and metabolic parameters were limited, and the combination was found to have a limited impact on liver function and lipid and carbohydrate metabolism. Moreover, its effect on several haemostatic parameters was lower than that of comparators containing ethinyl oestradiol (EE) 20 µg/DRSP 3 mg and EE 30 µg/levonorgestrel 150 µg. CONCLUSION: E4 15 mg/DRSP 3 mg provides safe and effective contraception, with high user satisfaction and predictable bleeding. Further research will evaluate the long-term safety of the COC.

Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia.

OBJECTIVES: To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. DESIGN: Multicenter, open-label, phase 3 trial. SETTING: Sixty-nine sites in Europe and Russia. POPULATION: Sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m2 . METHODS: E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary. MAIN OUTCOME MEASURES: Pearl Index (PI) for women 18-35 years (overall and method-failure), bleeding pattern and AEs. RESULTS: A total of 1553 women aged 18-50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman-years (95% CI 0.15-1.11); method failure PI was 0.29 pregnancies/100 woman-years (95% CI 0.06-0.83). Scheduled bleeding/spotting occurred in 91.9-94.4% of women over Cycles 1 to 12 and lasted a median of 4-5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment-related serious AE was reported, a lower extremity venous thromboembolism. One-hundred and forty-one (9.1%) women discontinued study participation because of treatment-related adverse events. CONCLUSION: E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile. TWEETABLE ABSTRACT: A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.

Contraceptive efficacy of sperm agglutinating factor from Staphylococcus warneri, isolated from the cervix of a woman with inexplicable infertility.

BACKGROUND: Voluntary control of fertility is of paramount importance to the modern society. But since the contraceptive methods available for women have their limitations such as urinary tract infections, allergies, cervical erosion and discomfort, a desperate need exists to develop safe methods. Vaginal contraceptives may be the answer to this problem, as these are the oldest ways of fertility regulation, practiced over the centuries. With minimal systemic involvement, these are also the safest. Natural substances blocking or impairing the sperm motility offer as valuable non-cytotoxic vaginal contraceptives. Antimicrobial peptides (AMPs) isolated from plants, animals and microorganisms are known to possess sperm immobilizing and spermicidal properties. Following this, in the quest for alternative means, we have cloned, over expressed and purified the recombinant sperm agglutinating factor (SAF) from Staphylococcus warneri, isolated from the cervix of a woman with unexplained infertility. METHODS: Genomic library of Staphylococcus warneri was generated in Escherichia coli using pSMART vector and screened for sperm agglutinating factor (SAF). The insert in sperm agglutinating transformant was sequenced and was found to express ribonucleotide-diphosphate reductase-α sub unit. The ORF was sub-cloned in pET28a vector, expressed and purified. The effect of rSAF on motility, viability, morphology, Mg++-dependent ATPase activity and acrosome status of human sperms was analyzed in vitro and contraceptive efficacy was evaluated in vivo in female BALB/c mice. RESULTS: The 80 kDa rSAF showed complete sperm agglutination, inhibited its Mg2+-ATPase activity, caused premature sperm acrosomal loss in vitro and mimicked the pattern in vivo showing 100% contraception in BALB/c mice resulting in prevention of pregnancy. The FITC labeled SAF was found to bind the entire surface of spermatozoa. Vaginal application and oral administration of rSAF to mice for 14 successive days did not demonstrate any significant change in vaginal cell morphology, organ weight and tissue histology of reproductive and non-reproductive organs and had no negative impact in the dermal and penile irritation tests. CONCLUSION: The Sperm Agglutinating Factor from Staphylococcus warneri, natural microflora of human cervix, showed extensive potential to be employed as a safe vaginal contraceptive.

Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.

OBJECTIVE: To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy. STUDY DESIGN: We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected precoital and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation. RESULTS: Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03). Of the 207 WC efficacy uses with evaluable postcoital PSA levels, 14.5% (30 uses) resulted in semen exposure compared to 14.2% (184 uses) of the 1293 evaluable WC functionality study uses. CONCLUSIONS: When evaluating the ability of an experimental condom to prevent semen exposure, the rate of clinical condom failure reported by participants risking pregnancy in an efficacy substudy was significantly higher than the rate reported by participants not risking pregnancy in a functionality study. The rate of semen exposure, assessed by an objective biomarker was nearly identical for the two studies. IMPLICATIONS: Our results suggest that an objective marker of semen exposure in functionality studies could provide a reasonable alternative to contraceptive efficacy studies in evaluating risk of unintended pregnancy and inferring protection from sexually transmitted infection than condom failure rates based on self-report.

Performance-Improvement Project: Increasing Nursing Knowledge of the Impact of Sugammadex in Female Patients Taking Steroidal Contraceptives.

PURPOSE: This process-improvement project improved postoperative education for female patients by facilitating the development of a topic-specific education program to improve knowledge and confidence among perianesthesia nurses in a military treatment facility. DESIGN: An educational program was developed and presented which reviewed the impact sugammadex has on steroidal contraceptive efficacy, evidence-based postoperative teaching strategies, and specific patient education recommendations for female sugammadex-exposed patients taking steroidal contraceptives. METHODS: Effectiveness was measured by comparing nurses' baseline knowledge and confidence scores before and immediately after presentation of the educational program. These results were then compared with 2-week reassessments to determine if lasting improvements were achieved. FINDINGS: Statistically significant increases in knowledge and confidence were achieved upon both postintervention assessments. CONCLUSIONS: Interactive evidence-based educational interventions can effectively create sustained increases in knowledge and confidence among health care professionals which translates into improved postoperative patient education.

Estimating six-cycle efficacy of the Dot app for pregnancy prevention.

OBJECTIVE: To assess six-cycle perfect and typical use efficacy of Dynamic Optimal Timing (Dot), an algorithm-based fertility app that identifies the fertile window of the menstrual cycle using a woman's period start date and provides guidance on when to avoid unprotected sex to prevent pregnancy. STUDY DESIGN: We are conducting a prospective efficacy study following a cohort of women using Dot for up to 13 cycles. Study enrollment and data collection are being conducted digitally within the app and include a daily coital diary, prospective pregnancy intentions and sociodemographic information. We used data from the first six cycles to calculate life-table failure rates. RESULTS: We enrolled 718 women age 18-39 years. Of the 629 women 18-35 years old, 15 women became pregnant during the first six cycles for a typical use failure rate of 3.5% [95% CI 1.7-5.2]. All pregnancies occurred with incorrect use, so we did not calculate a perfect use failure rate. CONCLUSIONS: These findings are promising and suggest that the 13-cycle results will demonstrate high efficacy of Dot. IMPLICATIONS: While final 13-cycle efficacy results are forthcoming, 6-cycle results suggest that Dot's guidance provides women with useful information for preventing pregnancy.

Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research.

BACKGROUND: Smartphone apps that provide women with information about their daily fertility status during their menstrual cycles can contribute to the contraceptive method mix. However, if these apps claim to help a user prevent pregnancy, they must undergo similar rigorous research required for other contraceptive methods. Georgetown University's Institute for Reproductive Health is conducting a prospective longitudinal efficacy trial on Dot (Dynamic Optimal Timing), an algorithm-based fertility app designed to help women prevent pregnancy. OBJECTIVE: The aim of this paper was to highlight decision points during the recruitment-enrollment process and the effect of modifications on enrollment numbers and demographics. Recruiting eligible research participants for a contraceptive efficacy study and enrolling an adequate number to statistically assess the effectiveness of Dot is critical. Recruiting and enrolling participants for the Dot study involved making decisions based on research and analytic data, constant process modification, and close monitoring and evaluation of the effect of these modifications. METHODS: Originally, the only option for women to enroll in the study was to do so over the phone with a study representative. On noticing low enrollment numbers, we examined the 7 steps from the time a woman received the recruitment message until she completed enrollment and made modifications accordingly. In modification 1, we added call-back and voicemail procedures to increase the number of completed calls. Modification 2 involved using a chat and instant message (IM) features to facilitate study enrollment. In modification 3, the process was fully automated to allow participants to enroll in the study without the aid of study representatives. RESULTS: After these modifications were implemented, 719 women were enrolled in the study over a 6-month period. The majority of participants (494/719, 68.7%) were enrolled during modification 3, in which they had the option to enroll via phone, chat, or the fully automated process. Overall, 29.2% (210/719) of the participants were enrolled via a phone call, 19.9% (143/719) via chat/IM, and 50.9% (366/719) directly through the fully automated process. With respect to the demographic profile of our study sample, we found a significant statistical difference in education level across all modifications (P<.05) but not in age or race or ethnicity (P>.05). CONCLUSIONS: Our findings show that agile and consistent modifications to the recruitment and enrollment process were necessary to yield an appropriate sample size. An automated process resulted in significantly higher enrollment rates than one that required phone interaction with study representatives. Although there were some differences in demographic characteristics of enrollees as the process was modified, in general, our study population is diverse and reflects the overall United States population in terms of race/ethnicity, age, and education. Additional research is proposed to identify how differences in mode of enrollment and demographic characteristics may affect participants' performance in the study. TRIAL REGISTRATION: ClinicalTrials.gov NCT02833922; http://clinicaltrials.gov/ct2/show/NCT02833922 (Archived by WebCite at http://www.webcitation.org/6yj5FHrBh).

Women's perceptions of contraceptive efficacy and safety.

BACKGROUND: Adoption of contraceptive implants and intrauterine devices has been less than might be expected given their superior efficacy and convenience. The purpose of this study was to assess knowledge and beliefs held by women, which may influence their contraceptive choices and theirongoing utilization of contraceptive methods. METHODS: English speaking, nonpregnant, reproductive-age women, who were not surgically sterilized, were individually interviewed to obtain limited demographic characteristics and to assess their knowledge about the efficacy of various contraceptive methods in typical use and about the relative safety of oral contraceptives. RESULTS: A convenience sample of 500 women aged 18-45 years, with education levels that ranged from middle school to postdoctoral level was interviewed. The efficacy in typical use of both combined oral contraceptives and male condoms was correctly estimated by 2.2%; over two-thirds of women significantly overestimated the efficacy of each of those methods in typical use. Oral contraceptives were thought to be at least as hazardous to a woman's health as pregnancy by 56% of women. CONCLUSIONS: The majority of reproductive aged women surveyed substantially overestimated the efficacy of the two most popular contraceptive methods, often saying that they were 99% effective. Women with higher education levels were most likely to overestimate efficacy of oral contraceptives. Women of all ages and education levels significantly overestimated the health hazards of oral contraceptives compared to pregnancy. Overestimation of effectiveness of these methods of contraception, may contribute to lower adoption of implants and intrauterine devices. When individualizing patient counselling, misperceptions must be identified and addressed with women of all educational backgrounds. TRIAL REGISTRATION: Not applicable.

Perfect-use and typical-use Pearl Index of a contraceptive mobile app.

OBJECTIVES: The Natural Cycles application is a fertility awareness-based contraceptive method that uses dates of menstruation and basal body temperature to inform couples whether protected intercourse is needed to prevent pregnancies. Our purpose with this study is to investigate the contraceptive efficacy of the mobile application by evaluating the perfect- and typical-use Pearl Index. STUDY DESIGN: In this prospective observational study, 22,785 users of the application logged a total of 18,548 woman-years of data into the application. We used these data to calculate typical- and perfect-use Pearl Indexes, as well as 13-cycle pregnancy rates using life-table analysis. RESULTS: We found a typical-use Pearl Index of 6.9 pregnancies per 100 woman-years [95% confidence interval (CI): 6.5-7.2], corrected to 6.8 (95% CI: 6.4-7.2) when truncating users after 12months. We estimated a 13-cycle typical-use failure rate of 8.3% (95% CI: 7.8-8.9). We found that the perfect-use Pearl Index was 1.0 pregnancy per 100 woman-years (95% CI: 0.5-1.5). Finally, we estimated that the rate of pregnancies from cycles where the application erroneously flagged a fertile day as infertile was 0.5 (95% CI: 0.4-0.7) per 100 woman-years. We estimated a discontinuation rate over 12months of 54%. CONCLUSIONS: This study shows that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness-based methods. The application may contribute to reducing the unmet need for contraception. IMPLICATIONS: The measured typical- and perfect-use efficacies of the mobile application Natural Cycles are important parameters for women considering their contraceptive options as well as for the clinicians advising them. The large available data set in this paper allows for future studies on acceptability, for example, by studying the efficacy for different cohorts and geographic regions.

LNG-IUS 12: a 19.5 levonorgestrel-releasing intrauterine system for prevention of pregnancy for up to five years.

INTRODUCTION: Globally, intrauterine devices (IUDs) are the second most commonly used form of reversible contraception because of their high efficacy, safety, convenience and cost effectiveness. The levonorgestrel releasing intrauterine system with daily average release of 20 mcg (LNG-IUS 20) is the popular choice because of its favorable bleeding patterns and many noncontraceptive benefits. A three year (LNG-IUS 8) became available three years ago. More recently, the LNG-IUS 12 was added. This new IUD shares a smaller frame, narrow inserter and lower rate of amenorrhea with the LNG-IUS 8, but it offers the five years of contraceptive protection of the LNG-IUS 20. Areas covered: This article provides information on the contraceptive efficacy, safety and tolerability of this new IUS based on approximately 60,000 cycles of use. Where available, the impacts of subject age, parity and body mass index (BMI) on study outcomes are reported. Expert opinion: This new LNG-IUS 12 with mid-dose hormone levels, smaller frame and longer effective life fills a niche that may better meet the needs of women who might appreciate the narrow insertion tube and/or the lower rates of amenorrhea. Cost will ultimately help determine success.

Reproductive Coercion by Male Sexual Partners: Associations With Partner Violence and College Women's Sexual Health.

Reproductive coercion (RC) involves indirect and direct partner behaviors that interfere with effective contraceptive use. RC has been identified as a correlate of intimate partner violence (IPV) among ethnically diverse women sampled from urban health clinics or shelters. Research is needed to determine whether RC is experienced more generally by young women and, if so, whether RC is associated with IPV, multiple indicators of sexual health, or both. In the present study, sexually active undergraduate women ( N = 223, 80% Caucasian/White) provided self-report data on their sexual health and behaviorally specific lifetime experiences of both RC and partner physical violence. About 30% reported experiencing RC from a male sexual partner. Most commonly, RC involved condom manipulation or refusal within an adolescent dating relationship. Experiences of RC and partner violence were not independent; half of the women who reported RC also reported experiencing partner physical violence. Women with a history of RC reported a significantly reduced rate of contraceptive use during last vaginal sex and lower contraceptive and sexual self-efficacy. Additional research on the sociocultural and relational contexts of RC is needed.