Vaginal Ring Research Articles

A multimodality review of gynecologic devices in the pelvis.

There are a wide variety of gynecologic devices encountered on pelvic imaging which may not be the focus or primary reason for imaging. Such devices include pessaries, menstrual products, radiation therapy devices, tubal occlusion devices, and contraceptive devices, including intrauterine devices and intravaginal rings. This manuscript offers a comprehensive review of multimodality imaging appearances of gynecologic devices encountered on pelvic imaging and discusses device indications, positioning, and complications.

Preference for novel biomedical HIV pre-exposure prophylaxis methods among adolescent girls and young women in Kampala, Uganda: a mixed methods study

BackgroundNovel HIV pre-exposure prophylaxis (PrEP) methods including a potential future HIV vaccine, will increase prevention options for adolescent girls and young women (AGYW) at high risk of HIV infection in Eastern and Southern Africa, yet data on AGYW’s preferences for various PrEP methods is limited. We investigated preferences for five biomedical PrEP methods (oral, injectable, vaginal ring, implant, HIV vaccine) among 14–24-years-old AGYW in Kampala, Uganda.MethodsFrom January to December 2019, we conducted a mixed methods study including 265 high-risk AGYW. After receiving two education sessions on the five PrEP methods, participants were asked about their “most preferred PrEP method.” Multinomial logistic regression (oral PrEP as reference category) was used to determine participant characteristics associated with method preference. Results are presented as adjusted relative risk ratios (aRRR) with 95% confidence intervals (CI). In-depth interviews were conducted with 20 selected participants to examine reasons influencing PrEP preferences and suggestions for method improvements. Transcripts were analyzed thematically.ResultsParticipants preferred methods were: HIV vaccine (34.7%), oral PrEP (25.7%), injectable PrEP (24.9%), PrEP implant (13.6%), and vaginal ring (1.1%). Preference for injectable PrEP increased with every year of age (aRRR 1.22; 95% CI 1.04–1.44) and among participants with chlamydia or gonorrhoea (aRRR 2.53; 95% CI 1.08–5.90), while it was lower among participants having sexual partner(s) living with HIV or of unknown HIV status (aRRR 0.30; 95% CI 0.10–0.91). Preference for PrEP implants also increased with age (aRRR 1.42; 95% CI 1.14–1.77) and was strong among participants having ≥10 sexual partners in the past 3 months (aRRR 3.14; 95% CI 1.16–8.55), while it was lower among those with sexual partner(s) living with HIV or of unknown HIV status (aRRR 0.25; 95% CI 0.07–0.92). PrEP method preference was influenced by product attributes and prior experiences with similar product forms commonly used in health care.ConclusionAGYW have varied preferences for biomedical PrEP method and those with higher sexual behavioral risk prefer long-acting methods. As we anticipate more available PrEP options, oral PrEP use should be supported among AGYW, especially for those with sexual partners living with HIV or of unknown HIV status.

Effect of various contraceptives on oocyte yield and maturation in patients undergoing planned oocyte cryopreservation

Research questionDo the various forms of hormonal and non-hormonal contraceptives have any association with ovarian stimulation outcomes, such as oocyte yield and maturation, in patients undergoing planned oocyte cryopreservation (POC)? DesignThis retrospective cohort study included all patients who underwent POC cycles between 2011 and 2023. The use of types of contraception before a POC cycle was recorded. The study evaluated the median number of cumulus–oocyte complexes obtained after vaginal oocyte retrieval and the proportion of metaphase II oocytes that underwent vitrification among all the cohorts. ResultsA total of 4059 oocyte freezing cycles were included in the analysis. Eight types of contraceptive method were recognized in patients undergoing ovarian stimulation: intrauterine device (IUD), copper (n = 84); IUD, levonorgestrel low dose (<52 mg) (n = 37); IUD, levonorgestrel (n = 192); subdermal etonogestrel implant (n = 14); injectable medroxyprogesterone acetate (n = 11); etonogestrel vaginal ring (n = 142); combined oral contraceptive pills (n = 2349); and norelgestromin transdermal patch (n = 10). The control group included patients not using contraceptives or using barrier or calendar methods (n = 1220). Among all the cohorts the median number of cumulus–oocyte complexes retrieved during oocyte retrieval was comparable (P = 0.054), and a significant difference in oocyte maturity rate with median number of vitrified oocytes was found (P = 0.03, P < 0.001, respectively). After adjusting for confounders a multivariate analysis found no association between the type of contraceptive and proportion of metaphase II oocytes available for cryopreservation. ConclusionsAmong the various forms of contraception, none was shown to have an adverse association with oocyte yield or maturation rate in patients undergoing POC.

Lessons learnt from daily oral PrEP delivery to inform national planning for PrEP ring introduction for women in low-income and middle-income countries: a qualitative inquiry of international stakeholders

IntroductionSome African countries plan to introduce and scale-up new long-acting pre-exposure prophylaxis methods (LA-PrEP), like the monthly dapivirine vaginal ring (PrEP ring) and injectable cabotegravir. National costed implementation plans, roadmaps...

Auditing the representation of hormonal contraceptives in studies assessing exercise performance in women

ABSTRACT Hormonal contraceptive (HC) users have a different ovarian hormonal profile compared to eumenorrheic women. Due to the prevalence of HC use amongst sportswomen, there has been increased research efforts to understand their impact on exercise performance. The aim was to audit this research. Studies identified were assessed for HC type, athlete calibre, performance outcome, study design, and quality of methodological control regarding ovarian hormonal profiles. Sixty-eight different HCs were reported across 61 studies. Monophasic combined oral contraceptive (OCP) pills represented 60% of HCs, followed by other pills [34%, phasic-combined, progestogen-only, and un-specified], phasic and long acting reversible contraceptives [5%, vaginal ring, patch, implant, injection, intrauterine system] and unspecified HCs (1%). Eleven percent of participants using HCs were classified as highly trained or elite/international with no participants being classed as world class. Whilst the number of studies involving HCs has increased two-fold over the past decade, the number of studies ranked as gold standard has not increased (HC; 2003–57%, 2011–55%, 2022–43%. OCP; 2003–14%, 2011–17%, 2022–12%). Future research assessing HCs and exercise performance should adopt high-quality research designs and include a broader range of HCs in highly trained to world-class populations to increase the reach and impact of research in this area.

Risks of Infections With Contraceptive Vaginal Rings Compared to No Hormone Use [ID 2683646

INTRODUCTION: Alterations in the vaginal microbiome by hormones, foreign bodies, intercourse, etc., can affect the body’s susceptibility to infection. The effect of combined contraceptive vaginal rings (CCVRs) on the vaginal microbiome needs more study. We aim to explore the outcomes of CCVRs on vaginal health and infection risk when compared to women without hormone use to better understand the effect of these devices. METHODS: De-identified data were collected from TriNetX. Using ICD-10 and RXNorm codes, populations were selected for women receiving etonogestrel and ethinyl estradiol CCVR without segesterone use, versus sexually active women of reproductive age on no hormonal contraceptives. Cohorts were matched for age at index, race, and ethnicity. Statistical analysis within 1 year of CCVR placement using risk ratios (RRs); P&lt;.05 was considered significant. RESULTS: Cohort sizes were 274,743 each. Combined contraceptive vaginal ring usage showed an increased risk of gonorrhea (RR 1.221; P=.012), HSV-2 (RR 1.229; P&lt;.0005), acute vaginitis (RR 1.314; P&lt;.0005), subacute/chronic vaginitis (RR 1.708; P&lt;.0005), acute vulvitis (RR 1.708; P&lt;.0005), subacute/chronic vulvitis (RR 1.722; P&lt;.0005), pelvic inflammatory disease (RR 1.184; P&lt;.0005), anogenital warts (RR 1.314; P&lt;.0005), and candidiasis (RR 1.402; P&lt;.0005) when compared to women receiving no hormonal contraception. Combined contraceptive vaginal ring showed significant decreased risk of chlamydia (RR 0.786; P&lt;.0005), syphilis (RR 0.493; P&lt;.0005), and HIV (RR 0.434; P&lt;.0005). Trichomoniasis was statistically insignificant. CONCLUSION: Women on etonogestrel and ethinyl estradiol CCVRs have an increased risk of gonorrhea, HSV-2, vaginitis, vulvitis, PID, anogenital warts, and candidiasis, with a decreased risk of chlamydia, syphilis, and HIV when compared to women receiving no hormonal contraception. Further investigation could be useful in developing multipurpose prevention technologies.

Risks of Vaginally and Sexually Transmitted Infections With Contraceptive Vaginal Rings Compared to Oral Contraceptives [ID 2683643

INTRODUCTION: Use of combined contraceptive vaginal ring (CCVR) has been found to upregulate immune-related genes in the endocervix and mediators within the cervicovaginal fluid. Attachment and infection rates of certain pathogens within this tract can vary based on hormones within the local environment. Rat studies have shown treatment with estrogen prior to chlamydial infections was protective. Continued clinical safety analyses are critical as CCVR use continues to increase. We calculated risk of vaginal infections associated with CCVR compared to oral contraceptive pills (OCPs) via retrospective chart review. METHODS: De-identified data was collected from TriNetX. Using ICD-10 and RxNorm codes, study cohorts included women receiving etonogestrel and ethinyl estradiol CCVRs without segesterone, versus women on OCPs without vaginal hormones. Cohorts (n=30,796 each) were matched for age, race, and ethnicity. Statistical analysis within 1 year of CCVR placement used risk ratios (RRs); P&lt;.05 was considered significant. RESULTS: Combined contraceptive vaginal rings showed increased risk of HSV-2 (RR 1.790; P&lt;.0005), acute vaginitis (RR 1.722; P&lt;.0005), subacute/chronic vaginitis (RR 1.904; P&lt;.0005), subacute/chronic vulvitis (RR 1.969; P&lt;.0005), acute vulvitis (RR 1.894; P&lt;.0005), candidiasis (RR 1.464; P&lt;.0005), trichomoniasis (RR 2.162; P&lt;.0005), and pelvic inflammatory disease (PID) (RR 2.984; P&lt;.0005). Combined contraceptive vaginal rings showed a decreased risk of chlamydia (RR 0.760; P=.047). There were no differences in risk of gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP cohorts CONCLUSION: In this chart review, women using CCVRs had increased risks for HSV-2, vaginitis, vulvitis, PID, trichomoniasis, and candidiasis and decreased risk of chlamydia compared to OCPs. Further study of local hormone delivery on the vaginal mucosa is warranted.

High adherence to intermittent and continuous use of a contraceptive vaginal ring among women in a randomized controlled trial in Kigali, Rwanda.

The introduction of female-initiated drug-delivery methods, including vaginal rings, have proven to be a promising avenue to address sexually transmitted infections and unintended pregnancies, which disproportionally affects women and girls in sub-Saharan Africa. Efficient uptake of existing and new technologies such as vaginal rings requires in depth understanding of product adherence. This remains a major challenge as data on adherence to vaginal rings from African countries is limited. In this study, we explored adherence of contraceptive vaginal ring (NuvaRing®) use in Kigali, Rwanda using a mixed methods approach. We collected quantitative and qualitative data at multiple time points from women participating in a clinical trial exploring the safety and acceptability of either intermittent or continuous use of the NuvaRing®. Various adherence categories were used including monthly and cumulative adherence measurement. The quantitative data were analysed using R and the qualitative data were analysed using a deductive, content-analytical approach based on categories related to the quantitative adherence measures. All data were compared and triangulated. Data from 120 enrolled participants showed that self-reported adherence was high at every study visit in both study groups. At first study visit 80% of the intermittent ring users and 79.7% of the continuous ring users reported perfect adherence (assessed as "the ring was never out"). Reporting of ring expulsions and removals were highest (28.3%) at the beginning of the trial. Self-reported perfect ring adherence increased during the study and reports of ring expulsions and removals declined as familiarity with this contraceptive method increased. The percentage of women with perfect cumulative adherence was non-significantly higher in the intermittent (61.7%) than in the continuous use group (54.3%). The low rate of discrepant adherence data after triangulation (6%) is in line with the perception of the participants as adherent throughout the study. Self-reported adherence in both study groups was high with removals and expulsions being within the expected product range. Comprehensive adherence data triangulation allowed for a deeper understanding of context-driven behaviour that shaped adherence patterns and challenges. Our data categorisation and triangulation approach has shown potential for implementation in future vaginal ring studies aiming to better understand and measure adherence.

Use of hormones and risk of venous thromboembolism.

•The risk of venous thromboembolism (VTE) is not increased in women using long-acting reversible contraceptive methods (LARCs) with progestogens. •Oral contraceptives with levonorgestrel or norgestimate confer half the risk of VTE compared to oral contraceptives containing desogestrel, gestodene or drospirenone. •Progestogen-only pills do not confer an increased risk of VTE. •Women using transdermal contraceptive patches and combined oral contraceptives (COCs) are at an approximately eight times greater risk of VTE than non-users of hormonal contraceptives (HCs), corresponding to 9.7 events per 10,000 women/years. •Vaginal rings increase the risk of VTE by 6.5 times compared to not using HC, corresponding to 7.8 events per 10,000 women/years. •Several studies have demonstrated an increased risk of VTE in transgender individuals receiving hormone therapy (HT). •Hormone therapy during menopause increases the risk of VTE by approximately two times, and this risk is increased by obesity, thrombophilia, age over 60 years, surgery and immobilization. •The route of estrogen administration, the dosage and type of progestogen associated with estrogen may affect the risk of VTE in the climacteric. •Combined estrogen-progesterone therapy increases the risk of VTE compared to estrogen monotherapy. •Postmenopausal HT increases the risk of thrombosis at atypical sites.

Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis

ObjectivesWe assessed associations between intravaginal practices (IVPs) and the incidence of sexually transmitted infections (STIs) and bacterial vaginosis (BV) among women using the dapivirine vaginal ring (DVR) or placebo vaginal...

A Review on Suppositories and Application of Vaginal Drug Delivery System

Historically, medications that caused unconsciousness, haemorrhoidal, germicidal, and purgative effects were administered the rectal route as suppository injections. The majority of medicinal drugs on the market today are designed to be administered rectal in order to increase their bioavailability and achieve the necessary therapeutic blood concentration. Historically, only locally acting medications, such as steroids, prostaglandins, spermicidal, antifungal, antibacterial, and antiviral, were allowed during vaginal birth. The capacity to avoid first-pass hepatic processing, accessibility, a healthy blood supply, and permeability to big molecular weight medications, such as peptides and proteins, are the main benefits of this route. Vaginal medicine delivery devices that are frequently utilised include suppositories, creams, gels, pills, and vaginal rings. This message is intended to give the reader an overview of the developments in the area of vaginal medication delivery.

Depression Among Pregnant and Breastfeeding Persons Participating in Two Randomized Trials of the Dapivirine Vaginal Ring and Oral Pre-Exposure Prophylaxis (PrEP) in Malawi, South Africa, Uganda, and Zimbabwe.

Depression is associated with lower adherence to oral pre-exposure prophylaxis (PrEP) to prevent HIV, but data are not currently available on how depression may affect use of other HIV prevention methods including the dapivirine vaginal ring (DVR). We conducted a mixed methods study using data from the Microbicide Trials Network (MTN) 042/DELIVER (n = 558) and MTN-043/B-PROTECTED (n = 197) studies to describe the prevalence of depressive symptoms and explore how depressive symptoms may have influenced attitudes about use of the monthly DVR and once-daily oral PrEP tablet among pregnant and breastfeeding persons, respectively, in Malawi, South Africa, Uganda, and Zimbabwe. Eleven participants had high Edinburgh Postnatal Depression scores ≥ 10 in MTN-042/DELIVER (2%) and four participants (2%) in MTN-043/B-PROTECTED. In interviews with 9 participants who had high scores (6 DVR, 3 oral PrEP), those with depressive symptoms described overlapping stressors which were magnified by job loss and economic instability during the COVID-19 pandemic, and by experiences of pregnancy/postpartum. These participants experienced a lack of support from partners or family members, and conflict with partners related to trust, and infidelity. While we did not find evidence of a change in product adherence, there was a strong sense of commitment and motivation to use the study products for protection from HIV for participants themselves and their baby. Although lack of social support is usually an obstacle to adherence, in this study, the participants' lives and relationships seemed to have reinforced the need for HIV prevention and motivated women to protect themselves and their babies from HIV.

Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis

The World Health Organization (WHO) recommends tenofovir disoproxil fumarate (TDF)-based oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring, and long-acting intramuscular injectable cabotegravir (CAB-LA) for HIV prevention in populations at substantial risk of HIV infection. Pregnancy is a period of elevated risk of maternal HIV infection and transmission to the infant. This systematic review and meta-analysis assessed the risk of adverse perinatal outcomes among HIV-negative pregnant women with exposure to any PrEP modality. We conducted a systematic review by searching Medline, EMBASE, CINAHL, Global Health, the Cochrane Library, WHO ICTR, ISRCTN, PACTR, and ClinicalTrials.gov for studies published between 1 January 2000 and 29 August 2023. We included studies reporting on the association of antenatal exposure to any PrEP modality with 13 perinatal outcomes: preterm birth (PTB), very PTB, spontaneous PTB, spontaneous very PTB, low birthweight (LBW), very LBW, term LBW, preterm LBW, small for gestational age (SGA), very SGA, miscarriage, stillbirth, or neonatal death (NND). Quality assessments of included studies were performed. Fixed-effect meta-analyses were conducted to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs). The protocol is registered with PROSPERO, CRD42022339825. Of 18,598 citations identified, 13 studies (eight randomised controlled trials (RCTs) and five cohort studies), assessing 8712 pregnant women in Africa, were included. Oral PrEP, compared to no PrEP, was not associated with PTB in meta-analyses of six RCTs (OR 0.73, 95% CI 0.43-1.26; I2=0.0%) or five unadjusted cohort studies (OR 0.84, 95% CI 0.69-1.03; I2=0.0%), but was associated with a reduced risk of PTB in three adjusted cohort studies (aOR 0.67; 95% CI 0.52-0.88, I2=0.0%). There was no association of oral PrEP with LBW, vLBW, SGA, or NND, compared to no PrEP. There was no association with PTB when oral TDF/emtricitabine (FTC) PrEP, oral TDF PrEP, and tenofovir vaginal gel were compared to each other. There was no association of the dapivirine vaginal ring with PTB or NND, compared to placebo or oral TDF/FTC PrEP. We found no data on CAB-LA. We found no evidence of adverse perinatal outcomes associated with PrEP exposure during pregnancy. Our findings support the WHO recommendation to provide oral PrEP to women of reproductive age and pregnant women. More data is needed to assess the safety of all PrEP modalities in pregnancy. None.

Indian women should be encouraged to use combined contraceptive vaginal ring

This article is to spread awareness among Indian women regarding vaginal contraceptive ring use. Since the introduction of hormonal contraceptives, combined oral pills (COCs) have become the method of choice for many women. Although COCs have improved significantly, they have got some disadvantages. This has prompted development of non-oral hormonal contraceptive methods. One of them is combined contraceptive vaginal ring (CCVR). Most studies found out that CCVR was associated with good cycle control and was not associated with vaginal or cervical abnormalities. Treatment related adverse effects like headache, leucorrhoea, nausea, etc and systemic side effects are minimal. Most women found the ring easy to insert, easy to remove and were satisfied with ring usage. So it can be concluded that CCVR is an effective contraceptive with good cycle control that is well tolerated. It is associated with high user and partner acceptability and minimal local and systemic effects. Therefore gynaecologists and policy makers should give more emphasis on its routine use.

Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application.

The current work describes the development of mechanistic vaginal absorption and metabolism model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations. Vaginal and cervix physiology parameters were incorporated in the model development. The study highlights the model assumptions including simulation results comparing systemic concentrations of 5 different compounds, namely, dapivirine, tenofovir, lidocaine, ethinylestradiol and etonogestrel, administered as vaginal ring or gel. Due to lack of data, the vaginal absorption parameters were calculated based on assumptions or optimized. The model uses release rate/in vitro release profiles with formulation characteristics to predict drug mass transfer across vaginal tissue into the systemic circulation. For lidocaine and tenofovir vaginal gel, the predicted to observed AUC0-t and Cmax ratios were well within 2-fold error limits. The average fold error (AFE) and absolute AFE indicating bias and precision of predictions range from 0.62 to 1.61. For dapivirine, the pharmacokinetic parameters are under and overpredicted in some studies due to lack of formulation composition details and relevance of release rate used in ring model. The predicted to observed AUC0-t and Cmax ratios were well within 2-fold error limits for etonogestrel and ethinylestradiol vaginal ring (AFEs and absolute AFEs from 0.84 to 1.83). The current study provides first of its kind physiologically based pharmacokinetic framework integrating physiology, population and formulation data to carry out in silico mechanistic vaginal absorption studies, with the potential for virtual bioequivalence assessment in the future.

The effects of COVID-19 pandemic on women’s access to maternal health and family planning services in Egypt: an exploratory study in two governorates

BackgroundThe COVID-19 pandemic has been noted to decrease access to maternal health and family planning services globally. However, evidence from the Middle East and North Africa region is very scarce and limited. We qualitatively explored women’s experiences in accessing maternal health and family planning services during the COVID-19 lockdown months in the two Egyptian governorates of Port Said and Souhag.MethodsUsing a case study design, semi-structured phone interviews were conducted with a total of 40 women aged 18–35 years from Port Said and Souhag governorates in Egypt. Interviews explored women’s experiences in accessing maternal health and family planning services during COVID-19 lockdown months, their coping strategies, and impact of challenges and/or coping strategies on participants and their families. The collected data was analyzed manually using qualitative thematic analysis.ResultsMany participants were unable to access maternal health and family planning services during COVID-19 lockdown due to fear of contracting the virus, closure of health facilities, changing service hours, family planning method or drug stock-outs, and/or financial constraints. The above challenges in accessing services along with coping strategies that some women and their families used exposed women to additional health risks, including unintended pregnancies, and posed several social, emotional, and financial burdens to many.ConclusionsThe COVID-19 pandemic and associated lockdown measures undermined women’s access to maternal and family planning services and interfered with their ability to achieve their reproductive goals. The paper concludes with a number of recommendations to ensure access to maternal and family planning services at times of crisis. Those recommendations include: (1) adapting reliable guidelines from humanitarian settings, (2) providing adequate guidance to healthcare providers and the public to tackle fears and misinformation, (3) making self-care products available such as oral contraceptive pills, vaginal rings and self- administered injectables, (4) involving other health professionals in the provision of maternal and family planning services through task-sharing/shifting, (5) expanding the use of telemedicine and/or digital health services especially to those living in remote areas and (6) raising policymakers’ awareness of the centrality of reproductive rights and the importance of protecting them at all times.

The state-of-art polyurethane nanoparticles for drug delivery applications.

Nowadays, polyurethanes (PUs) stand out as a promising option for drug delivery owing to their versatile properties. PUs have garnered significant attention in the biomedical sector and are extensively employed in diverse forms, including bulk devices, coatings, particles, and micelles. PUs are crucial in delivering various therapeutic agents such as antibiotics, anti-cancer medications, dermal treatments, and intravaginal rings. Effective drug release management is essential to ensure the intended therapeutic impact of PUs. Commercially available PU-based drug delivery products exemplify the adaptability of PUs in drug delivery, enabling researchers to tailor the polymer properties for specific drug release patterns. This review primarily focuses on the preparation of PU nanoparticles and their physiochemical properties for drug delivery applications, emphasizing how the formation of PUs affects the efficiency of drug delivery systems. Additionally, cutting-edge applications in drug delivery using PU nanoparticle systems, micelles, targeted, activatable, and fluorescence imaging-guided drug delivery applications are explored. Finally, the role of artificial intelligence and machine learning in drug design and delivery is discussed. The review concludes by addressing the challenges and providing perspectives on the future of PUs in drug delivery, aiming to inspire the design of more innovative solutions in this field.

A nine-month repeat-dose intravaginal ring (Ovaprene) irritation study in sheep

ObjectivesOvaprene is a novel, investigational, intravaginal hormone-free monthly ring contraceptive designed for use in women of reproductive age to be worn over multiple weeks (one menstrual cycle). The objective of this work was to evaluate the safety of Ovaprene during a nine-month repeat-dose sheep study. Study designIn addition to traditional safety endpoints such as histopathological evaluation of the sheep female reproductive tract, vaginal fluids were collected and tested for released iron over time. Also, the amount of iron in the rings was assessed following removal, and serum iron levels were measured. There were four sheep in each group (Ovaprene group and sham group). ResultsThere were no macroscopic clinical findings. There was minimal to mild, mixed or mononuclear cell infiltration present in all levels of vagina (cranial, mid, and caudal) from all animals including sham controls based on post-study necropsy. The female reproductive tract from animals treated with the Ovaprene ring was comparable to the sham controls. The concentrations of serum iron in sheep treated with Ovaprene ring were similar compared to a sham treated animal. The average amount of ferrous gluconate released from Ovaprene over the 29-day period of use was 175 mg of the approximately 512 mg nominally loaded into the rings. ConclusionsOverall, the Ovaprene devices were well-tolerated in female sheep. ImplicationsThis study should support a chronic (e.g., one year) contraceptive efficacy study in women.

Effectiveness and continuation rates of the etonogestrel-subdermal contraceptive implant versus short-acting contraceptive methods offered at no cost in Campinas, Brazil.

To compare the efficacy, reasons for discontinuation and continuation rates of the etonogestrel (ENG)-subdermal contraceptive implant when offered at no cost, and the basis of free choice versus short-acting reversible contraceptive (SARC) methods including combined oral contraceptives (COCs), once-a-month injectables, vaginal ring, and patch. We conducted a prospective study at the University of Campinas, Brazil, involving women aged 18 to 40 years. They were counseled on various contraceptive methods before entering the study and followed up every 3 months for up to 24 months. Satisfaction was assessed using a Likert scale. Survival rates were estimated using the Kaplan-Meier test, and curve comparisons were performed using the log-rank test. We enrolled 609 women including 358/609 women (58.8%) who chose the ENG-implant and 251/609 (41.2%) who chose SARC methods. Contraceptive failure and all other reasons for discontinuation were significantly higher in SARC users compared to the ENG-implant users (P < 0.001 and P = 0.002, respectively). The continuation rate was higher among ENG-implant users (89.9% and 75.4%) compared to SARC methods users (27.2% and 15.9%) up to 1 and 2 years after study initiation, respectively. Satisfaction was high in both groups (>82%). The ENG-implant showed higher contraceptive effectiveness and higher continuation rates than SARC methods up to 2 years after study initiation. Furthermore, users from both groups were highly satisfied with their contraceptive. The main reason for discontinuing use of the ENG-implant was bothersome uterine bleeding, while for SARC methods it was for personal reasons.

Qualitative focus group discussions exploring PrEP method and service delivery preferences among female sex workers and their managers in four Zambian provinces

ObjectivesTo describe the experiences of oral HIV pre-exposure prophylaxis (PrEP) use, preferences comparing oral PrEP to future long-acting PrEP products (the dapivirine vaginal ring (PrEP ring) and injectable cabotegravir (CAB...