Surface roughness of different contraceptive vaginal rings: evaluation by scanning electron microscope (SEM).

Objective: The aim of the study was to evaluate whether the compositions of the ethylene vinyl acetate (EVA) membrane of two different contraceptive vaginal rings could influence the surface roughness, which is associated with the possible accumulation of vaginal biomass on the rings during use.Methods: We measured and compared the surface roughness of unused vaginal rings, NuvaRing and Ornibel, using a scanning electron microscope (SEM) and dedicated software that can convert SEM images into 3D models. Average roughness (Ra), average quadratic roughness (Rq) and mean height of the irregularities at 10 points (Rz) were calculated.Results: Different thicknesses of the EVA membranes between the two rings were noted. No significant differences were found between the two rings in the three evaluated values of surface roughness (NuvaRing vs Ornibel, respectively: Ra, 1.53 ± 0.14 vs 1.61 ± 0.14 µm, p = 0.141; Rq, 2.03 ± 0.25 vs 2.07 ± 0.16 µm, p = 0.688; Rz, 11.4 ± 3.1 vs 11.4 ± 2.4 µm, p = 0.987).Conclusion: The different composition of the vaginal rings' EVA membrane is not associated with different surface roughness. Ornibel is equivalent to NuvaRing in terms of surface roughness, despite the different composition of the membrane polymers.

In vitro evaluation of microbial adhesion to a contraceptive vaginal ring with a new polymer composition.

Objective: The aim of the study was to evaluate in vitro the amount of Candida albicans and Lactobacillus acidophilus adhering to the surface of Ornibel, a contraceptive vaginal ring with a new polymer composition, in comparison with NuvaRing. Methods: Ornibel and NuvaRing were tested for adhesion of microorganisms in vitro. The vaginal rings were aseptically sectioned into 1 cm segments. Suspensions of C. albicans (1-2 × 107 colony-forming units [CFU]/ml) and L. acidophilus (1-2 × 108 CFU/ml) were prepared and incubated either in monoculture or as co-culture with the ring segments. After incubation, adherent C. albicans and L. acidophilus were quantified by plate counting. Results: In monoculture, the measured amount of adhesion of C. albicans on the ring surface was significantly lower with Ornibel compared with NuvaRing (p = 6.77 × 10-5), while the adherence of L. acidophilus did not differ between the two rings. Similarly, when co-incubated with C. albicans, the number of adhering L. acidophilus microorganisms was significantly lower with Ornibel compared with NuvaRing (p = .018) . This reduction also resulted in significantly lower levels of adhering L. acidophilus in co-culture compared with L. acidophilus when incubated alone (p = .003). Conclusion: The study demonstrates that the adherence of C. albicans, as well as that of L. acidophilus when co-cultured with C. albicans, is lower with the Ornibel vaginal ring compared with NuvaRing. These in vitro findings warrant future human trials using molecular techniques to assess the vaginal microbiota composition and to establish whether Ornibel can support vaginal health.

Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17ß-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing.

PURPOSE: To identify at least one contraceptive vaginal ring that effectively inhibits ovulation and demonstrates cycle control that is non-inferior to NuvaRing® (Merck Sharp & Dohme B.V., The Netherlands) in terms of an unscheduled bleeding incidence, with a non-inferiority margin of 10%. METHODS: This was a randomised, active controlled, parallel group, multicentre, partially blinded trial in healthy women 18-35 years of age. Subjects received one of six contraceptive vaginal rings with an average daily release rate of 300 µg 17ß-estradiol (E2) and various rates of either etonogestrel (ENG; 75, 100, or 125 µg/day) or nomegestrol acetate (NOMAC; 500, 700, or 900 µg/day), or the active control NuvaRing® (ENG/ethinylestradiol 120/15 µg), for three 28-day cycles. RESULTS: Ovulation inhibition was observed in all groups as confirmed by absence of progesterone concentrations compatible with ovulation (>16 nmol/L) and absence of ultrasound evidence of ovulation. All investigational rings provided good cycle control, with the ENG-E2 125/300 µg/day group being associated with the best cycle control based on the numerically lowest incidence of unscheduled bleeding and absence of scheduled bleeding. Non-inferiority to NuvaRing® with respect to the incidence of unscheduled bleeding could not be concluded for any of the investigational ring groups. The safety profile was consistent with the known safety profile of combined estrogen/progestin contraceptives and similar across all groups. CONCLUSIONS: Contraceptive rings releasing 300 µg E2 and 75-125 µg/day of ENG or 500-900 µg/day of NOMAC provided adequate ovulation inhibition and cycle control and are generally well-tolerated. While non-inferiority to NuvaRing® was not met, among the investigational rings, the ENG-E2 125/300 ring provided the best cycle control.

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

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

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring® (etonogestrel/ethinylestradiol 11.7/2.7 mg).

OBJECTIVE: To show the clinical development of Ornibel® (ExeltisHealthcare, Spain) a contraceptive vaginal ring manufactured with a new polymer composition and containing etonogestrel/ethinylestradiol, compared to Nuvaring® (MSD, Spain). SUBJECTS AND METHODS: Randomised, single dose, 2-period, 2-sequence, 2-stage crossover, comparative bioavailability study conducted in 40 healthy female subjects. All subjects received both treatments for 28 days in each of two periods, separated by a 28 days washout. Ornibel® contains etonogestrel/ethinylestradiol 11.00/3.47 mg and Nuvaring® contains etonogestrel/ethinylestradiol 11.7/2.7 mg, both rings delivering 120/15 µg/day. For the calculation of pharmacokinetic parameters, 37 blood samples were collected up to 840 h after each ring insertion to quantify plasma concentrations of etonogestrel and ethinylestradiol using a validated MS/MS-HPLC. Safety was assessed by adverse events recording, clinical laboratory and vital signs and tolerability by vaginal examination. Acceptability was investigated by a 5-point scale questionnaire. RESULTS: Bioequivalence was demonstrated in the first stage as the 94.12% Confidence Intervals of the primary parameters laid within the 80-125% acceptance range for both etonogestrel (Cmax: 96.81-112.20%; AUC0-504h: 98.71-108.61%; AUC0-t: 100.14-109.10%) and ethinylestradiol. (Cmax: 105.91-120.62%; AUC0-504h: 105.47-114.59%; AUC0-t: 108.31-117.61%). During the first day of use a burst effect was observed with Nuvaring®, with significantly higher level of ethinylestradiol (Cmax0-24h ratio: 78.34%, 94.12CI: 73.55-83.45%). Both products were well tolerated and accepted, without significant differences between them. CONCLUSION: Ornibel® is bioequivalent to Nuvaring® in terms of efficacy, safety, tolerability and acceptability. The new polymer composition provides Ornibel® with more stability and gradual hormonal release during the first day of use, particularly for ethinylestradiol.

Establishment of a Molding Procedure to Facilitate Formulation Development for Co-extrudates.

Co-extrusion offers a number of advantages over conventional manufacturing techniques. However, the setup of a co-extrusion line is cost- and time-intense and formulation development is challenging. This work introduces a novel procedure to test the applicability of a co-extruded reservoir-type system at an early product development stage. We propose vacuum compression molding (VCM), a fast procedure that requires only small material amounts, for the manufacturing of cylindrical reservoir-type system. To this end, the commercially available co-extruded product NuvaRing® and variations thereof were used as test systems. All VCM systems showed a homogeneous skin thickness that adhered well to the core, thereby providing a precise core/skin interface. As drug release is a key criterion for pharmaceutical products, a modified in vitro dissolution method was set up to test the VCM systems. The drug release from the VCM systems was in the same order of magnitude as the corresponding co-extruded strands and followed the same release kinetics. Moreover, the VCM systems were capable of indicating the relative effect of formulation-related modifications on drug release. Overall, this shows that this system is a powerful tool that facilitates formulation tailoring and co-extrusion process setup at the earliest stage.

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

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

Comparison of combined hormonal vaginal ring with ultralow-dose combined oral contraceptive pills in the management of heavy menstrual bleeding: A pilot study.

The aim of this study was to compare combined hormonal vaginal ring with ultralow-dose combined oral contraceptive (COC) pills in management of heavy menstrual bleeding (HMB). Fifty patients were randomised into Group I: vaginal ring (n = 25) and group II: COC pills (n = 25). Menstrual blood loss (MBL) was assessed at baseline, 1, 3 and 6 months (while on treatment) and at 9 months (3 months after stopping therapy). There was significant reduction in baseline pictorial blood loss assessment chart (PBAC) score from 440 ± 188 (Mean ± SD) to 178 ± 95, 139 ± 117, 112 ± 84 and 120 ± 108 in group I and from 452 ± 206 to 204 ± 152, 179 ± 125, 176 ± 164 and 202 ± 167 in group II at 1, 3, 6 and 9 months, respectively (p = 0.001). Reduction in MBL was 72% and 62% at 6 months and up to 71% and 55% at 9 months in group I and group II, respectively (p = 0.001). Reduction in MBL with ring was greater at higher baseline PBAC score but lesser in patients with fibroid > 2 cm. Combined vaginal hormonal treatment for HMB is as effective as oral hormonal therapy, with minor and transient side effects and persistence of response after cessation of therapy.

Contraceptive Vaginal Rings: Do They Pose an Increased Risk of Venous Thromboembolism in Aesthetic Surgery?

UNLABELLED: Nuvaring (Organon, Kenilworth, NJ) is a vaginal contraception ring inserted by the patient. It was approved by the Food and Drug Administration in 2001 for the prevention of pregnancy. The intent of this paper is to increase the awareness of Nuvaring among plastic surgeons, and to explore the risks associated with its use. We report the cases of two cosmetic surgery patients. These patients developed deep venous thrombosis and pulmonary emboli in the postoperative period while using Nuvaring. The very advantages of the Nuvaring-the ease of use, the avoidance of daily administration, and the insertion and removal of the device by the patient-may lead to the failure of patients to recollect being on a vaginal ring for contraception. LEVEL OF EVIDENCE: 4 Risk.

Desogestrel-only contraceptive pill versus sequential contraceptive vaginal ring in the treatment of rectovaginal endometriosis infiltrating the rectum: a prospective open-label comparative study.

OBJECTIVE: To compare the efficacy of two hormonal therapies in treating symptoms caused by bowel endometriosis. DESIGN: Patient preference study. SETTING: University hospital. POPULATION: A total of 143 women with rectovaginal endometriosis infiltrating the rectum. METHODS: This study was performed between January 2008 and June 2011. Patients were treated with a desogestrel-only contraceptive pill or with the sequential combined contraceptive vaginal ring for 12 months. MAIN OUTCOME MEASURES: The primary endpoint of the study was the rate of satisfied patients at 12-month follow up. The changes in symptoms and in the volume of the nodules were secondary endpoints. RESULTS: At 12-month follow up, the rate of satisfied patients was higher in the group treated with the desogestrel-only contraceptive pill than in the group treated with the sequential combined contraceptive vaginal ring (p = 0.004). When only changes in gastrointestinal symptoms were considered, 50% of patients treated with the desogestrel-only contraceptive pill and 31.3% of those treated with the sequential combined contraceptive vaginal ring were satisfied (p = 0.037). The reduction in the volume of the nodules, the percentages of patients who discontinued the therapy after the completion of the study and of those who decided to undergo surgery were similar between the two groups. CONCLUSIONS: Both hormonal therapies are efficacious in treating symptoms caused by rectovaginal endometriosis infiltrating the rectum. Patient satisfaction is higher with the desogestrel-only pill than with a vaginal ring.

The vaginal ring (NuvaRing®) for contraception in adolescent women.

Adolescence is a phase of life of utmost importance for the present and future physical, psychological, and social health of individuals of both genders. Contraception as a preventive measure and behavior has to be integrated into this developmental context. The aim hereby is not only the prevention of unwanted pregnancies, but also the maintenance and promotion of reproductive and sexual health in a broader sense. This includes protection against sexually transmitted diseases (STI), preservation of fertility, promotion of a self-determined and satisfying sexual life, diminution of general health risks and prevention of diseases which may occur later in life. The vaginal contraceptive ring seems to respond to most of these needs except for protection against STI. In conclusion, the vaginal ring is for these reasons an important option in the contraceptive care of adolescents.

The contraceptive vaginal ring, NuvaRing(®), a decade after its introduction.

OBJECTIVES: To review the clinical experience with the contraceptive vaginal ring (CVR, NuvaRing(®)) since its introduction over ten years ago. METHODS: The literature was searched on efficacy, cycle control, safety, user preference and satisfaction of the CVR in comparison with combined oral contraceptives (COCs) and the patch, with special attention to recent developments. RESULTS: The ring has the same working mechanism and contraindications as COCs. Serum levels of steroids are steadier, whereas oestrogenic exposure is lower. Contraceptive efficacy is similar, as are metabolic changes. Cycle control is better, and compliance and continuation rates are equal or higher. Oestrogen-related adverse symptoms appear to be fewer, but reports on the incidence of venous thrombosis are conflicting. Expulsion of the ring is reported by 4% to 20% of women. Local adverse events are the main reason for discontinuation. Acceptability is as high as with COCs and, after structured counselling, the ring is preferred by many women to the pill or the patch. CONCLUSIONS: Efficacy of the CVR, and the metabolic changes and adverse events it elicits, are generally comparable to those of COCs, yet oestrogenic exposure is lower and cycle control superior. After counselling, the ring is preferred to the pill by many women.

Effect on carbohydrate metabolism and analysis of acceptability (menstrual cycle control) of extended regimens of the vaginally inserted hormone-releasing system 'NuvaRing' as compared with the standard 21/7 regime in reproductive-age women with type 1 diabetes mellitus.

AIM: To evaluate the effect of the vaginally inserted hormone-releasing system 'NuvaRing' on carbohydrate metabolism and acceptability (menstrual cycle control) of extended regimens of using as compared with the standard regimen (21/7) in women with type 1 diabetes mellitus (DM) in reproductive period during 24 months. METHODS: The open randomised study included a total of 109 women with type 1 DM, using 'NuvaRing' in different regimens (21/7, 42/7, 84/7 and 357/7). Average daily insulin requirements, the levels of glycosylated haemoglobin were determined at baseline, after 6, 12, 18 and 24 months of contraception. The control group was composed of 22 age-matched women with type 1 DM using no methods of contraception. RESULTS: Using the contraceptive system 'NuvaRing' in type 1 DM women in the reproductive period has proved to exert no clinically significant effect on carbohydrate metabolism in prolonged regimens, as well as in standard regimen. The overall number of bleeding days and spotting days was comparable in different groups. Longer regimens with fewer breaks were associated with fewer days of bleeding but a larger number of spotting days as compared with the shorter regimens, with a tendency towards a gradual decrease in spotting days during a year. CONCLUSION: The releasing system 'NuvaRing' proved to be a reliable and safe means of contraception for late reproductive age women with type 1 DM.

An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).

INTRODUCTION: Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention. METHODS: UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring® or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring® (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods. RESULTS: Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring® (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring® users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring® , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill. CONCLUSIONS: Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.

[Vaginal combined contraception NuvaRing in the clinical practice in the Czech Republic]. / Klinickié zkusenosti s kombinovanou vaginální antikoncepcí NuvaRing v Ceské republice.

OBJECTIVE: The aim of this non-interventional, non-comparative, prospective, multicentric study was to evaluate use of vaginal combined contraception NuvaRing in the clinical practice in the Czech Republic. DESIGN: Non-interventional, non-comparative, prospective, multicentric study. SETTING: Department of obstetrics and gynecology, General Faculty Hospital Prague, 1st Faculty of Medicine, Charles University Prague. METHODS: The cohort of 2134 new users of NuvaRing was followed for 6 months. Questionnaire was filled in by the physician (gynaecologist) three times during the study--before the start of NuvaRing use (baseline), after 3 months and after 6 months of the ring use. RESULTS: The average age of women in study was 29.5 years, 68.2% was from 21 to 35 years old. Insertion and removal of the ring were evaluated as easy in 95% of women in the end of the study. Irregular bleeding was mentioned only in 19.7% of women during first 3 cycles and 7.8% during last 3 cycles, mostly (90%) as spotting. Menstrual bleeding was shorter in 62.8% of women in the end of the study compared with the baseline. Dysmenorea decreased by 34.9% and PMS by 28.8% in the last evaluated cycle compared with the baseline. No feeling or only exceptional feeling the of the ring in the vagina was reported in 87% of women and in 77.9% of their sexual partners during the last 3 cycles. The main two reasons why women like NuvaRing was no need to remember anything (57.5%) and easy use (34%). The main reasons why women dislike the ring were feeling of the ring in the vagina in 2.9%, disturbing of sexual intercourse in 2.4% and irregular bleeding in 2%. (90% answered, that they like NuvaRing.) CONCLUSIONS: After six months of use 89% of women was satisfied or highly satisfied with the vaginal ring and 91% of the users was decided to recommend this contraception method to other women.

Frequency and management of breakthrough bleeding with continuous use of the transvaginal contraceptive ring: a randomized controlled trial.

OBJECTIVE: To assess bleeding patterns with continuous use of the transvaginal contraceptive ring. METHODS: We did a prospective analysis of daily menstrual flow during a 21/7 cycle followed by 6 months of continuous use and institution of a randomized protocol to manage breakthrough bleeding/spotting. Seventy-four women completed the baseline 21/7 phase and were randomized equally into two groups during the continuous phase. Group 1 was instructed to replace the ring monthly on the same calendar day with no ring-free days. Group 2 was instructed to use the same process, but if breakthrough bleeding/spotting occurred for 5 days or more, they were to remove the ring for 4 days, store it, and then reinsert that ring. RESULTS: Sixty-five women completed the continuous phase with reduced average flow scores in the continuous phase compared with the 21/7 phase (P<.02). Most patients had no to minimal bleeding during continuous use, with group 2 experiencing a statistically greater percentage of days without breakthrough bleeding or spotting (95%) compared with group 1 (89%) (P=.016). Instituting a 4-day hormone-free interval was more (P<.001) effective in resolving breakthrough bleeding/spotting than continuing ring use. CONCLUSION: A reduction in bleeding occurred during continuous use with replacement of the transvaginal ring compared with baseline 21/7 use. Continuous vaginal ring use resulted in an acceptable bleeding profile in most patients, reduction in flow, reduction in pelvic pain, and a high continuation rate.

An open-label, multicentre trial to evaluate the vaginal bleeding pattern of the combined contraceptive vaginal ring NuvaRing.

OBJECTIVE: The objective of this multicentre, non-controlled, open-label study is the evaluation of the bleeding patterns during the use of a vaginal combined contraceptive, its safety in relation to occurrence of adverse effects, its efficacy as a contraceptive method and user compliance. STUDY DESIGN: Healthy female volunteers (N=165), asking for contraception, were enrolled to participate in the study. Each subject was given seven vaginal rings, releasing an average amount of 120microg etonogestrel (ENG) and 15microg ethinylestradiol (EE) per day. Study period was 7 cycles. A total of 878 cycles was valid for statistical analysis. The primary parameter, (breakthrough bleeding and/or spotting), was recorded for each cycle. The subjects were asked to report any adverse effect experienced during the treatment period, general physical and gynaecological examinations were performed and haematological blood tests were taken. RESULTS: Breakthrough bleeding/spotting occurred in 5.01% cycles (44 out of 878 cycles, of whom 37 were breakthrough spotting only). Absence of withdrawal bleeding during the ring-free period was reported in 1.94% cycles (17 out of 878). Forty-one subjects (24.8%) reported 66 events that were potentially drug-related. The most frequently drug-related events were weight increase (10 cases), headache (9 cases), nausea (4 cases). No pregnancy was reported during the study period. Haematology and chemical chemistry tests showed no clinically significant abnormality. CONCLUSIONS: In the present study, NuvaRing has shown to be a valid contraceptive method to ensure optimal cycle control with low incidence of irregular bleeding and altered withdrawal bleeding. The low incidence of gastrointestinal side effects (nausea, vomiting) may be related the low hormonal dose and to the vaginal delivery of hormones which avoids the gastrointestinal tract.

Review of the vaginal contraceptive ring (NuvaRing).

NuvaRing represents another useful contraceptive option for women. The vaginal administration confers benefits and women do not appear to dislike this route of hormone delivery. Efficacy and cycle control are the least comparable to conventional COCs and adverse events are minimal, though vaginal side effects are reported more commonly. Women may find that trying to insert the ring in the clinic will allay any concerns they have with regard to insertion and removal.

The latest advances in hormonal contraception.

Millions of women each year start or continue to use some type of hormonal contraceptive method. Choosing a method may be anxiety provoking. In this article, we review some of the latest advances in and options for hormonal contraception, including extended-dose oral contraceptives, the vaginal ring, injectable methods, and emergency contraception. Nurses can facilitate women's decision making for healthy reproductive options.