Severe anemia from heavy menstrual bleeding requires heightened attention.

OBJECTIVE: The objective of the study was to analyze the behaviors of women that resulted in menstrually related severe anemia (hemoglobin <5 g/dL) from a single public hospital serving indigent women. STUDY DESIGN: This was a retrospective cohort study of all women identified as having been treated at Harbor-UCLA Medical Center for excessive menstruation (International Classification of Diseases, ninth revision, codes 285.9, 6256.2) and hemoglobin values less than 5 g/dL in the 6 years from 2008 to 2013. RESULTS: Approvals were obtained from the Human Subjects and Research Committees. This search identified 271 women with those 2 diagnoses; 122 were excluded because their severe anemia had nonmenstrual causes. The remaining 149 women had 168 episodes with hemoglobin levels below 5 g/dL attributed to chronic excessive menstrual bleeding. Mean age was 41 years (range, 19-55 years). Mean body mass index was 28.9 kg/m(2) (range, 18-57 kg/m(2)); 58.2% were actively bleeding at presentation, and 90.4% reported chronic excessive blood loss. Two thirds recognized heavy bleeding that had persisted for more than 6 months without seeking help. However, 7.8% described their bleeding as normal, and 40.5% had received at least 1 previous transfusion. Mean nadir hemoglobin was 4.15 g/dL (range, 1.6-4.9 g/dL). Mean corpuscular volume was 62.2 fL (range, 47.7-99.8 fL) and mean corpuscular hemoglobin concentration was 29.2 g/dL (range, 25.7-33.6 g/dL). Nearly a quarter had reactive thrombocytosis, which might have created a hypercoagulable state. Bleeding was ultimately attributed to leiomyoma in 47.9%; cancer was detected in 4.8%. A total of 33.9% were discharged without being offered any therapy to prevent subsequent bleeding; 3.0% declined any medical therapy; 35.1% were lost to follow-up prior to receiving effective therapy; and 26.8% had multiple subsequent transfusions before seeking/receiving definitive treatments. CONCLUSION: Even when faced with potentially life-threatening anemia because of chronic, excessive menstrual blood loss, some women are not impressed with the serious nature of their problem. Women will benefit from recognizing the health consequences of chronic excessive blood loss. Chronic excessive blood loss should be treated as both an urgent and potentially recurrent problem; physicians should address this clinical concern proactively.

Mothers with Breastfeeding Difficulty Report Increased Depressive Symptoms and Impaired Maternal-Infant Bonding on Social Media.

Background: Protection against postpartum depression is a commonly cited maternal benefit of breastfeeding. However, recent studies have found that negative breastfeeding experiences may actually increase the risk of depressive symptoms. Objective: To investigate women's self-reported associations between breastfeeding experiences and depressive symptoms on a social media platform. Study Design: An electronic search was conducted on Reddit of all original user posts using keywords "breastfeeding" and "depression" from February 2013 to July 2021. Relevant posts and corresponding comments were manually extracted, evaluated for inclusion and exclusion criteria, and analyzed for thematic content. Results: In total, 584 entries was analyzed. Mothers most frequently described difficulty breastfeeding as the cause of new onset mental health symptoms (53%); however, mothers breastfeeding without difficulty were also susceptible (20%). Mothers also reported exacerbated preexisting mental health symptoms-predominantly related to difficulty breastfeeding (17%), but again, others experienced no difficulty (6%). Common words included among all entries were "guilt" (17%), "fail" (14%), "pressure" (7%), "shame" (6%), and "alone" (6%). Among mothers mentioning bonding (n = 99), 58% reported that breastfeeding inhibited infant bonding, versus 1% enhanced bonding; furthermore, 63% reported increased bonding after switching to formula versus 8% unchanged and 6% decreased bonding. Nearly one-quarter (23%) of all posts described inadequate breastfeeding counseling. Finally, 9% of all posts reported a negative experience with health care providers versus 6% a positive experience. Conclusions: Mothers struggling to breastfeed may not experience the classically described benefits of breastfeeding, instead experiencing increased depressive and other mental health symptoms and impaired maternal-infant bonding. Furthermore, limited provider disclosure about potential breastfeeding challenges and alternatives to breastfeeding may exacerbate mental health symptoms associated with breastfeeding difficulties. Balanced information should be presented to mothers contemplating breastfeeding in order to minimize maternal perceptions of "failure."

Microscopic ferning in human pre-ejaculate is highly correlated with the absence of sperm.

OBJECTIVE: We characterize microscopic ferning in pre-ejaculate samples with and without sperm. STUDY DESIGN: Healthy, male, withdrawal-experienced participants provided up to three paired pre-ejaculate and ejaculate samples. We centrifuged ejaculate samples to obtain a supernatant without sperm. After sperm analysis, we dried and evaluated pre-ejaculate, ejaculate, and supernatants for microscopic ferning. RESULTS: Of 57 pre-ejaculate samples (N = 24 men), seven (12.3%) contained sperm, none of which exhibited ferning. Sixty-six percent (33/50) of pre-ejaculate samples without sperm exhibited ferning. Neither ejaculate nor supernatant samples exhibited ferning. CONCLUSION: Ferning may distinguish clinical pre-ejaculate with and without sperm. Ferning exhibited 100% specificity for pre-ejaculate without sperm.

Low to non-existent sperm content of pre-ejaculate in perfect-use contraceptive withdrawal, a pilot study.

OBJECTIVE: To assess pregnancy risk following perfect use of the withdrawal method by quantification of sperm in pre-ejaculate. STUDY DESIGN: We conducted a pilot study of sperm and factors linked to its presence in pre-ejaculate samples among healthy, reproductive-age, withdrawal-experienced men. Participants provided up to three paired pre-ejaculate and ejaculate specimens in 72-hour intervals. We analyzed samples for volume, consistency, sperm concentration, count, and motility. We set clinical pregnancy risk as our primary outcome, defined as sperm concentration >1million/mL. RESULTS: From 70 paired samples (N = 24 participants, median age: 27 years), we identified sperm in nine (12.9%) pre-ejaculate samples, from six (25.0%) participants. Only seven samples contained sperm in concentrations of significant clinical pregnancy risk. All ejaculatory specimens contained motile sperm in concentrations of significant pregnancy risk. CONCLUSION: In this study of the pre-ejaculate of perfect-use withdrawal users, motile sperm were usually absent, or found inconsistently and in insufficient quantities to confer significant clinical pregnancy risk. IMPLICATIONS: While correct and consistent withdrawal use is likely to be highly effective, given that motile sperm in concentrations >1 million/mL are usually absent or inconsistently present in pre-ejaculate, clinical trial data is lacking.

How Do Women Vote: What Women Post About Home Birth Versus Hospital Birth on Popular Social Media Platforms.

INTRODUCTION: The rates of home birth have been increasing; reliance on social media as a source of medical advice and support for patients has also been increasing. This is the first study that directly evaluates birthing people's perceptions, attitudes, and advice about planned home births expressed in public posts and comments on two popular social media platforms - Reddit and TikTok. METHODS: Posts on each platform were searched from January 2017 through July 2022 using the terms "home birth" and "home vs. hospital birth". Included posts were from the United States written in English, with at least 10 comments and 10 upvotes or likes. Up to five themes were collected per post or comment and were categorized as supportive, opposing, or neutral. The Institutional Review Board (IRB) determined that the project did not include human subjects. RESULTS: Collectively, 777 posts and 47,452 comments were evaluated for inclusion; 257 posts and 2,408 comments met the inclusion criteria for analysis. In posts, 69% supported, 20% opposed, and 11% were neutral toward home birth (n = 257). Similarly, in comments, 53% supported, 28% opposed, and 19% were neutral (n = 2,408). Supportive themes included concerns about the safety of hospital delivery and reassurance about home birth safety, enhanced patient control with home deliveries, positive personal stories reinforcing home birth, concerns about excessive interventions in hospital birth, and advice about preparing for home birth. Opposing themes included concerns about risks of home birth, negligence of those attempting it, reassurance that hospital birth does offer women control, greater financial costs of home birth and that medical interventions can be lifesaving. CONCLUSION: These results can help physicians recognize some of the women's concerns about hospital births and what information they may find on social media guiding them as they formulate their birth plans. Overall, this information helps with the goal of balancing patient safety with the need to respect patient autonomy.

Five years later: Can women in Los Angeles County, California, get adequate pill supplies?

OBJECTIVES: This study sought to determine if pharmacies in Los Angeles County had implemented 2017 legislation requiring insurance companies based in California to fully reimburse for 13 cycles of oral contraceptives dispensed at once. STUDY DESIGN: We conducted a secret shopper telephone survey of Los Angeles County pharmacies nearly 5 years after the legislation went into effect. We chose the categorical state family program (Family PACT) to represent all programs covered by the legislation. Representative numbers of pharmacies were randomly selected in each of Los Angeles County's eight service planning areas in proportion to the number of women living in each area. We asked pharmacies if they would fill a prescription for a year's supply of contraception all at once for a patient enrolled in Family PACT. RESULTS: We contacted a total of 582 pharmacies and excluded the 150 unresponsive pharmacies. Of the 432 pharmacies contacted, only 3.2% said they would dispense a 1-year supply of pills at once to a patient enrolled in this representative program. Nearly 50% explicitly said they would not dispense 13 cycles at one time regardless of the prescription. CONCLUSIONS: Only 3.2% of surveyed pharmacies in Los Angeles County said they would comply with current legislation, which requires dispensing 1-year supply of pills at once. IMPLICATIONS: Collaboration among physicians, pharmacies, and patients along with enhanced insurance company oversight will be needed to improve dispensing practices to achieve the lower unintended pregnancy rates associated with providing adequate contraceptive supplies.

Prevalence and treatment outcome of cervicitis of unknown etiology.

BACKGROUND: Mucopurulent cervicitis (MPC) is a clinical syndrome characterized by mucopurulent discharge from the cervix and other signs of inflammation. This was a phase III, multicenter study designed to evaluate the effectiveness of placebo versus empiric antibiotic treatment for clinical cure of MPC of unknown etiology at 2-month follow-up. Unfortunately, enrollment was terminated because of low accrual of women with cervicitis of unknown etiology, but important prevalence and outcome data were obtained. METHODS: Five hundred seventy-seven women were screened for MPC. Women with MPC were randomized to the treatment or placebo arm of the study, and the 2 arms were evaluated based on the etiology, clinical cure rates, adverse events (AEs), and rates of pelvic inflammatory disease. RESULTS: One hundred thirty-one (23% [131/577]) screened women were found to have MPC. Eighty-seven were enrolled and randomized. After excluding women with sexually transmitted infections and other exclusions, 61% (53/87) had cervicitis of unknown etiology. The overall clinical failure rate was 30% (10/33), and the clinical cure rate was only 24% (8/33). Rates were not significantly different between the arms. There were 24 gastrointestinal AEs in the treatment arm compared with 1 AE in the placebo arm. CONCLUSIONS: More than half of the cases of MPC were of unknown etiology. Clinical cure rates for the placebo and treatment arms were extremely low, with most women concluding the study with a partial response. Gastrointestinal AEs were higher in the treatment arm.

A new progestogen-only medical therapy for outpatient management of acute, abnormal uterine bleeding: a pilot study.

OBJECTIVE: The objective of this investigation was to study short-term efficacy and feasibility of a new progestogen-only treatment for outpatient management of acute abnormal uterine bleeding. STUDY DESIGN: This was a prospective, single-arm, pilot clinical trial of a progestogen-only bridging treatment for acute abnormal uterine bleeding in nonpregnant, premenopausal women in the Gynecologic Urgent Care Clinic at Harbor-UCLA Medical Center. Subjects were administered a depo-medroxyprogesterone acetate 150 mg intramuscular injection and given medroxyprogesterone acetate 20 mg to be taken orally every 8 hours for 3 days. The primary outcome measures included a percentage of women who stopped bleeding in 5 days, time to bleeding cessation, reduction in numbers of pads used, side effects, and patient satisfaction. RESULTS: All 48 women stopped bleeding within 5 days; 4 women had spotting only at the time of their last contact during the 5 day follow-up. Mean time to bleeding cessation was 2.6 days. Side effects were infrequent and patient satisfaction was high. CONCLUSION: Injection of depo-medroxyprogesterone acetate 150 mg intramuscularly combined with 3 days of oral medroxyprogesterone acetate 20 mg every 8 hours for 9 doses is an effective outpatient therapy for acute abnormal uterine bleeding.

Drospirenone and estetrol: evaluation of a newly approved novel oral contraceptive.

INTRODUCTION: Estetrol (E4) is a native estrogen produced only by the fetal liver during pregnancy. E4 is the first new estrogen to be used in hormonal contraception since the introduction of oral contraceptives in 1960. Ethinyl estradiol, the most commonly used estrogen in oral contraceptives today, increases the risks of thromboembolism and has other significant hepatic impacts, which induce important drug-drug interactions. On the other hand, Phase 2 E4 characterization studies demonstrated that E4 has negligible impacts on liver, breast, and vascular endothelium due to its distinct tissue selectivity. Combined with drospirenone (DRSP), E4 offers an improved safety profile for oral contraception. AREAS COVERED: This paper briefly highlights the unique pharmacokinetic and pharmacodynamic features of E4. The efficacy, safety, and tolerability results from the Phase 2 and 3 studies of the E4/DRSP pill are discussed to provide the reader with a thorough understanding of E4 and information to use when counseling potential users. EXPERT OPINION: The estetrol/drospirenone oral contraceptive is effective and well tolerated and provides good cycle control. In the future, estetrol may be the estrogen of choice if subsequent evidence verifies that it reduces the risks associated with current estrogens, such as venous thromboembolism and drug-drug interactions.

Satisfaction with a Segesterone Acetate and Ethinyl Estradiol Contraceptive Vaginal System Among Recent Oral Contraceptive or Hormonal Contraceptive Vaginal Ring Users.

Background: We evaluated satisfaction with use of a segesterone acetate and ethinyl estradiol (0.15/0.013 mg) contraceptive vaginal system (CVS) among women who had recently used a monthly contraceptive vaginal ring or contraceptive pills. The CVS is a ring-shaped device used in a 21-days-in/7-days-out regimen for 13 cycles. Materials and Methods: We analyzed post hoc satisfaction responses at cycle 3 and end of study (EOS) from a subset of participants with documented recent use of the monthly ring or daily pills before enrollment in a multinational, phase 3, 13-cycle trial evaluating the CVS. EOS included results from participants who had completed ≥10 cycles. Results were summarized descriptively. Results: We identified 128 recent ring and 219 recent pill users at cycle 3 (of 1033 survey participants), and 92 and 148, respectively, at EOS (of 622 survey participants); overall satisfaction with CVS use was high (≥90%). At EOS, most ring (89%) and pill (97%) users liked the CVS as much/better than any previous method. The two most-liked CVS features included ease of use and 1-year duration; the two most disliked features included ring insertion and feeling it coming out. At EOS, ≥88% of both groups reported no concern about using the same CVS for a year, and most (>80%) had recommended it to friends or family members. Conclusion: The CVS clinical trial participants who were recent ring/pill users reported high satisfaction and liked it as much/better than any previously used contraceptive; the CVS may be a good contraceptive option for switchers. Clinical trial registration NCT00263341.

Unmet Needs Discussed on Reddit by Women with Premenstrual Dysphoric Disorder.

Premenstrual dysphoric disorder (PMDD) is a disabling disorder that impacts 1.8 percent to 5.8 percent of menstruating women for 1-2 weeks each month. Many affected women turn to social media platforms for the information and the support they feel that they do not get from other sources. We sought to better understand the most strongly expressed unmet needs of women with PMDD by analyzing their posts and comments on one of the largest social media platforms (Reddit), which has been providing important insights into other medical problems. We searched Reddit using the subreddit title "r/PMDD" for posts from January 2020 through November 2021. To identify the most prevalent issues, we included all written posts with a submission score of at least 5 and at least three comments. Two authors classified each post; inconsistencies were resolved by a third reviewer. Over 800 posts were reviewed; 250 met study criteria; additionally, over 875 comments were evaluated. Four main themes emerged from the analysis: emotional responses to PMDD; unanswered questions women had about the diagnosis and treatment of PMDD; the impact that PMDD had on personal relationships, and, finally, the recommendations women made to others based on their own experience, accurate or not. These themes are detailed in this article to provide insights into what many women with PMDD experience and what their frustrations and misunderstandings are about the condition so that clinicians may better help address women's unspoken questions and correct their possible misinformation.

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users. Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment. Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively. Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy. Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).

The new low-dose transdermal contraceptive system (Twirla®): results from preclinical and Phase III trials.

A new low-dose, once-a-week contraceptive transdermal delivery system (TDS) with 2.3-mg ethinyl estradiol (EE) and 2.6-mg levonorgestrel (LNG; Twirla®) has recently been approved by the US FDA for contraception of women with BMI <30 kg/m2. The rationale for developing this new patch, the preclinical study results and the results from two innovative Phase III clinical trials demonstrate that this patch has an acceptable Pearl index (4.3%) for its indicated users and has safety and tolerability comparable to other similar dose oral combined hormonal contraceptives. This new TDS provides an improvement over the existing TDS products, with significantly lower steady-state estrogen exposure, a level equal to that with 30-µg EE containing oral contraceptives.

Lay abstract A new patch with lower doses of estrogen than existing contraceptive patches has been approved by the US FDA for birth control for women who are not obese. It has been tested in two large clinical trials that included women who are like the general population of reproductive age women in the USA. Up-to-date electronic diaries were used to get the most accurate information to use to counsel women who might appreciate the convenience of once-a-week patch use. The patch worked better in lighter women than those who were heavier, and it appears to be safer in women with lower BMIs too.

The potential for intramuscular depot medroxyprogesterone acetate as a self-bridging emergency contraceptive.

OBJECTIVE: To examine the rate of ovulatory disruption when intramuscular depot medroxyprogesterone acetate (DMPA) is administered across graded stages of dominant follicle development. STUDY DESIGN: We assigned enrolled participants to one of three preassigned dominant follicle size groups: 12-14 mm, 15-17 mm and ≥ 18 mm. We followed dominant follicles via serial transvaginal ultrasound (TVUS) until the follicles reached their assigned size, at which time we administered DMPA. For 5 consecutive days thereafter, we followed the follicles via TVUS to observe follicle rupture and obtained serum luteinizing hormone (LH), estradiol, and progesterone concentrations. In the following 2 weeks, we collected serum progesterone concentrations twice weekly to detect possible ovulatory delay or dysfunction. We also collected serum medroxyprogesterone acetate (MPA) concentrations at 1 and 24 h after DMPA administration to examine against ovulatory outcomes. RESULTS: Twenty-six of 29 enrolled women completed the study. DMPA suppressed ovulation in 17/26 (65%) and caused ovulatory dysfunction in 1/26 (4%) participants. Larger follicles were more likely to rupture despite DMPA (12-14 mm: 0/10 (0%); 15-17 mm: 3/10 (30%); ≥ 18 mm: 6/6 (100%); p < .01). Pre-DMPA LH concentrations ranged from 13.8 to 93.7 IU/L (mean 49.0 IU/L) in cases of follicle rupture. We observed no cases of follicle rupture when DMPA was administered through cycle day 12. All 24-h MPA concentrations exceeded those needed for ovulation suppression. CONCLUSION: DMPA suppressed and additionally disrupted ovulation in 65% and 4% of observed cycles, respectively. DMPA may provide effective emergency contraception as well as ongoing contraception if administered prior to an expected ovulation and specifically before the LH surge. IMPLICATIONS: DMPA may be an alternative form of emergency contraception that can also self-bridge to ongoing contraception. As ovulation was not observed among any follicles when DMPA was given through cycle day 12, women who initiate DMPA up through cycle day 12 may not require backup contraception.

Detecting variations in ovulation and menstruation during the COVID-19 pandemic, using real-world mobile app data.

BACKGROUND: As war and famine are population level stressors that have been historically linked to menstrual cycle abnormalities, we hypothesized that the COVID-19 pandemic could similarly affect ovulation and menstruation among women. METHODOLOGY: We conducted a retrospective cohort study examining changes in ovulation and menstruation among women using the Natural Cycles mobile tracking app. We compared de-identified cycle data from March-September 2019 (pre-pandemic) versus March-September 2020 (during pandemic) to determine differences in the proportion of users experiencing anovulation, abnormal cycle length, and prolonged menses, as well as population level changes in these parameters, while controlling for user-reported stress during the pandemic. FINDINGS: We analyzed data from 214,426 cycles from 18,076 app users, primarily from Great Britain (29.3%) and the United States (22.6%). The average user was 33 years of age; most held at least a university degree (79.9%). Nearly half (45.4%) reported more pandemic-related stress. Changes in average cycle and menstruation lengths were not clinically significant, remaining at 29 and 4 days, respectively. Approximately 7.7% and 19.5% of users recorded more anovulatory cycles and abnormal cycle lengths during the pandemic, respectively. Contrary to expectation, 9.6% and 19.6% recorded fewer anovulatory cycles and abnormal cycle lengths, respectively. Women self-reporting more (32.0%) and markedly more (13.6%) stress during the pandemic were not more likely to experience cycle abnormalities. CONCLUSIONS: The COVD-19 pandemic did not induce population-level changes to ovulation and menstruation among women using a mobile app to track menstrual cycles and predict ovulation. While some women experienced abnormalities during the pandemic, this proportion was smaller than that observed prior to the pandemic. As most app users in this study were well-educated women over the age of 30 years, and from high-income countries, their experience of the COVID-19 pandemic might differ in ways that limit the generalizability of these findings.

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results.

OBJECTIVE: To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLAⓇ) containing levonorgestrel (LNG) and ethinyl estradiol (EE). STUDY DESIGN: This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used. RESULTS: The study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m2. In the primary efficacy analysis, the PI (95% confidence interval) was 5.8 (4.5-7.2) pregnancies per 100 woman-years. PIs trended higher as BMI increased; the PI was 4.3 (2.9-5.8) in women with BMI <30 kg/m2 and 8.6 (5.8-11.5) in women with BMI ≥30 kg/m2. Hormone-related treatment-emergent adverse events included nausea (4.1%) and headache (3.6%); 11% of women discontinued due to adverse events. Four women (all with BMIs ≥30 kg/m2) reported thromboembolic events considered related to treatment. CONCLUSIONS: The low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m2. The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the US Food and Drug Administration approval of TWIRLAⓇ for prevention of pregnancy in women with BMI <30 kg/m2. IMPLICATIONS: TDS (120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI <30 kg/m2. TDS has reduced effectiveness in women with BMI ≥30 kg/m2.

Awareness of Pregnancy-Associated Health Risks Among Pregnant Women and Male Partners Surveyed in a Prenatal Clinic.

Background: Underestimation of pregnancy-associated health risks could compromise informed decision-making and reduce demand for preconception care. We assessed the knowledge of pregnant women and male partners about several health risks posed by pregnancy to identify potential gaps in reproductive health literacy. Materials and Methods: Pregnant women and male partners were surveyed about their knowledge of seven common health risks associated with pregnancy (venous thromboembolism [VTE], diabetes, gallstones, hemorrhoids, hypertension [HTN], kidney infection, and anemia) in either English or Spanish in a prenatal clinic at Harbor-UCLA Medical Center in Torrance, California. Results: The response rate for women was estimated to be 66% and was 85% for men. Of the 285 respondents, 5.0% of women and 5.6% of men were able to correctly report that all seven health risks increased during pregnancy. Overall, 30.6% of women and 24% of men recognized that pregnancy increased the risks of the three most serious conditions (VTE, diabetes, and HTN). While higher education was associated with a higher awareness of these three serious risks, the majority of individuals with the highest education nonetheless incorrectly reported that these risks were reduced or unchanged in pregnancy. Age, parity, language, gender, and gestational age did not impact study findings. Overall, 77.9% of respondents rated oral birth control pills more hazardous to a woman's health than pregnancy. Conclusions: Surveyed pregnant women and male partners have significant knowledge deficiencies concerning common and serious health hazards associated with pregnancy that may hamper women's ability to make informed choices about their reproductive health options.

Efficacy, Safety, and Tolerability of a New Low-Dose Copper and Nitinol Intrauterine Device: Phase 2 Data to 36 Months.

OBJECTIVE: To assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator. METHODS: Institutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with a 2-year extension. Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns. RESULTS: A total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients. Over 36 months of observation, we identified two pregnancies (Pearl Index 0.46 [95% CI 0.06-1.67]) and 10 serious adverse events; none were study-related. Successful placement occurred in 283 participants (99.0%). Median (range) continuation times were 2.7 years (0-3.4). We identified five expulsions (1.8%), zero uterine perforations, and one report of pelvic inflammatory disease. Adverse events prompted 30 women (10.6%) to discontinue early in the first year of use with 23 (8.1%) discontinuing for issues of bleeding, pain, or both. Altogether, 107 (37.8%) completed 36 months of device use. Mean bleeding days per cycle decreased from 7.6 in cycle 1 to 5.2 in cycle 13. CONCLUSION: The novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02446821. FUNDING SOURCE: Sebela Pharmaceuticals, Inc.

Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinylestradiol: A new year-long, patient controlled, reversible birth control method.

Introduction: This is an overview of the recently FDA-approved silicone elastomer combined hormonal contraceptive vaginal ring (CVR), which is used cyclically for up to 1 year, eliminating resupply challenges. This ring requires no refrigeration, simplifying the supply chain. Developed by the Population Council, this CVR will soon be marketed in the United States as Annovera™ by TherapeuticsMD. Areas Covered: The composition of the elastomer ring and the chemical, pharmacokinetic and pharmacodynamic properties of both hormonal components are discussed. Results of the clinical trials of its efficacy, tolerability, safety, and acceptability follow. Finally, subanalyses from the clinical trials are presented to guide clinicians in counseling potential users. Expert Opinion: This CVR introduces a new progestin - segesterone acetate (SA) - that has no androgenic or estrogenic action in vitro or in vivo, but has the highest anti-ovulatory potential of all available progestins. SA is paired with EE in an intravaginal elastomer ring, that is used cyclically (21 days in place/7 days removed) to provide 12 months (13 cycles) of contraception. This once-a-month, self-applied CVR offers a convenient, rapidly reversible, year-long contraception with efficacy and side effect profiles similar to other combined hormonal methods, for women with BMI < 29 kg/m2.