Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive

BACKGROUND: Many women discontinue their use of hormonal contraception, and even those who continue so may have difficulty using oral contraceptive pills consistently. New delivery systems, including the vaginal ring, may be easier to use, but user acceptability and satisfaction with these new methods may be affected by women's experience with their bodies. MATERIALS AND METHODS: Data for this study were collected as part of a randomized clinical trial on 201 women comparing immediate start of vaginal ring use with immediate start of low-dose oral contraceptive use. We assessed user satisfaction and method continuation 3 months after ring or pill initiation. RESULTS: At 3 months, 174 of 201 subjects (87%) had follow-up interviews. Among the 174 study participants with follow-up data, 61% of ring subjects and 34% of pill subjects were very satisfied with their methods (p=.003). For posttrial contraception, 79% of ring subjects chose to continue with the ring whereas 59% of pill subjects chose to continue with the pill (p<.001). Women who reported greater comfort in touching their genitals, greater frequency of masturbation, more comfort with intercourse and past use of vaginal contraceptives and products were not more likely than others to be satisfied with the ring or to continue using it for birth control. CONCLUSION: Women who were allocated to vaginal ring use, regardless of their baseline characteristics or behavior, were likely to be highly satisfied with the method and to continue its use.     

Factors associated with willingness to use the contraceptive vaginal ring

INTRODUCTION: The objective of this study was to examine factors associated with willingness to use the contraceptive vaginal ring among college students. MATERIAL AND METHODS: We electronically surveyed a random sample of female undergraduates. Factors associated with willingness to use the contraceptive vaginal ring were evaluated using a logistic regression model. RESULTS: Six hundred ninety-one women answered the survey. Willingness to use the contraceptive vaginal ring was positively associated with willingness to use the contraceptive patch, being employed at least 20 h/week, acceptability of a monthly contraceptive, acceptability of self-insertion, acceptability of feeling ring during intercourse and concern over potential hormonal side effects. Willingness to use the contraceptive vaginal ring was negatively associated with current use of oral contraceptives. DISCUSSION: Busy lifestyle and acceptance of its characteristics were associated with willingness to use the contraceptive vaginal ring. Counseling should focus on addressing women's concerns about vaginal administration and side effects.     

Extended regimens of the combined contraceptive vaginal ring containing etonogestrel and ethinyl estradiol: effects on lipid metabolism

Background

Oral contraceptives used for extended periods of time have been studied because of their potential benefits; however, there have been few publications on extended regimens of vaginal contraceptive rings. The aim of this study was to evaluate modifications in the lipid profile of women using the vaginal ring continuously over a 1-year period.

Study Design

This prospective cohort enrolled 75 women (18–37 years) who used a contraceptive vaginal ring releasing 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily continuously for 84 days, followed by a 7-day ring-free interval, during 1 year. At baseline and every 3 months during the 1-year study period, blood was collected to assess cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides and apolipoproteins A-I and B. The ANOVA test was used to analyze differences in the results of these exams over time.

Results

After 1 year of continuous contraceptive use, there was a significant increase in triglycerides as well as in total and HDL-C levels. There was a nonsignificant decrease in the mean concentration of LDL-C during the study period. Apolipoprotein A-I increased and apolipoprotein B decreased, but the apolipoprotein A-I/apolipoprotein B ratio did not change significantly.

Conclusion

The combined contraceptive vaginal ring used on an extended regimen causes changes in the lipid profile metabolism of users. Despite the vaginal route of administration, the steroids released by the ring caused significant changes in lipids and lipoproteins, which were typical of those seen with ethinyl estradiol given either orally or parenterally.     

Extended regimens of the vaginal contraceptive ring: cycle control

Background

Oral contraceptives used for extended periods of time have been extensively studied because of their potential benefits; however, there have been few publications on extended regimen of vaginal rings. The aim of this study was to compare the bleeding patterns of women using extended regimens of the vaginal ring or oral contraceptives.

Study Design

Prospective cohort involving 150 women: 75 used vaginal rings that release 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily, and 75 took oral contraceptives containing ethinyl estradiol 0.3 mcg and desogestrel 150 mcg. Both groups used their respective contraceptive method over continuous periods of 84 days, followed by a 7-day pause, during 1 year.

Results

The total number of scheduled bleeding and spotting days decreased significantly during the 1-year period of the study for both methods (p=.001), and this decrease was significantly higher for oral contraceptive users. Similarly, during the study period, there was a significant reduction in the total number of unscheduled bleeding and spotting days for both methods (p=.01), but this decrease was significantly higher among vaginal ring users (p=.003).

Conclusion

Vaginal ring used on an extended regimen is a contraceptive method that offers good cycle control.     

The combined contraceptive vaginal ring,NuvaRing: an international study of user acceptability

The acceptability of the combined contraceptive vaginal ring, NuvaRing, was assessed during two trials conducted in North America and Europe. Women completed a questionnaire about the ring's clarity of instructions, ease of use, sexual comfort, cycle-related characteristics and satisfaction after 3, 6 and 13 cycles of use. A total of 1,950 women (82% of those recruited) completed a questionnaire at cycle 3. At baseline, 66% of participants preferred oral contraceptives, but after three cycles of ring use 81% preferred the ring. On study completion, 97% agreed that the instructions for use were clear; 85% of women and 71% of their partners never/rarely felt the ring during intercourse and 94% of partners never/rarely minded that the woman was using the ring. Overall acceptance was high, 96% were satisfied with the ring and 97% would recommend the ring. Similar responses were seen for women who prematurely discontinued from the studies, except that slightly fewer women were satisfied (60%) and would recommend the ring (75%). Reasons for liking the ring included 'not having to remember anything' (45%) and 'ease of use' (27%). In conclusion, there is a high level of user and partner acceptability for the contraceptive ring.     

Feasibility study of Nestorone-ethinylestradiol vaginal contraceptive ring for emergency contraception

OBJECTIVE: The Nestorone/ethinylestradiol (NES/EE) vaginal ring is being developed as a regular contraceptive method by the Population Council. This ring is designed to release NES 150 microg/day and EE 15 microg/day during 1 year. Here, we report a Phase I clinical trial to determine the usefulness of this ring for emergency contraception. To that end, we tested the ability of this ring to interfere with ovulation when it is inserted during the follicular phase. METHOD: Forty-eight women protected from the risk of pregnancy by nonhormonal methods were divided into three groups, which differed by the size of the dominant follicle at the time of ring insertion: 12-14 mm (n = 16), 15-17 mm (n = 18) and >or=18 mm (n = 14) diameter. The NES/EE ring was left in the vagina for 7 consecutive days, after which it was removed. The growth of the leading follicle and plasma levels of estradiol, progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the ensuing 5 days after ring insertion were determined. Afterwards, steroid hormones were measured twice a week, until menses took place. All women had a control cycle before the ring cycle, and the range of maximum follicular diameter assigned to each volunteer was the same for the control and the ring cycle at the time when placebo was ingested or the ring inserted. RESULTS: During the 5-day period after ring insertion with follicles 12-17 mm, ovulation was absent in 25 of 34 cycles (p < .01 vs. control), and ovulatory dysfunction (absent, blunted or mistimed LH peak) occurred in 8 of the 9 remaining cycles (33/34 ovulatory processes altered; p < .005 vs. control). After ring insertion with follicles >or=18 mm in diameter, ovulation did not occur in 2 of 14 cycles or was dysfunctional in 7 of the 12 remaining cycles (9/14 ovulatory processes altered; p<.025 vs. control). Altogether, 87.5% of ring cycles (42/48) had either no ovulation or ovulatory dysfunction in the 5-day study period, in contrast to 39.6% (19/48 cycles) in control cycles (p < .001). Among follicles that failed to rupture within the 5-day study period, none ruptured later on in the ring-treated cycles, while 9 of 16 did so in control cycles. Sixty-two percent of ring-treated cycles were shorter than 24 days. Nausea, vaginal discharge and abdominal pain were the most frequently reported adverse events during ring use. CONCLUSION: Interference with 87.5% of ovulatory processes, without ovulation occurring later in the cycle and shortening of cycle length, suggests the NES/EE ring may be used as an emergency contraceptive method, with the potential advantage of providing continuing contraception after it has performed its emergency function.     

The contraceptive vaginal ring compared with the combined oral contraceptive pill: a comprehensive review of randomized controlled trials

BACKGROUND: The purpose of this review was to compare pharmacology, contraceptive efficacy, cycle control, side effects and acceptability with the combined contraceptive vaginal ring (CCVR) and combined oral contraceptives (COCs). STUDY DESIGN: All randomized controlled trials (RCTs) between the CCVR and a COC up to and including December 2006 were analyzed. RESULTS: Twelve RCTs comparing the CCVR and a COC were identified. Systemic exposure to ethinyl estradiol (EE) with the CCVR was half of that with a 30-microg EE-containing COC with less variation in serum levels. During CCVR use, sex hormone-binding globulin and cortisol-binding globulin concentrations were significantly less increased than during COC use. Both methods showed adequate ovarian suppression and equal contraceptive efficacy. Uterine concentrations of EE and etonogestrel were not elevated with the CCVR. Cycle control achieved with the CCVR was better than that of the COC. Compliance with both methods was high. Mean blood pressure and body weight did not change in either group. Incidence of adverse events such as breast tenderness, headache and nausea was comparable, but a higher incidence of local and ring-related events led to higher discontinuation rates in the CCVR group. Both contraceptives were highly acceptable and resulted in a global improvement of sexual function. Ring users were more likely to continue with their method after study completion than COC users. CONCLUSIONS: The vaginal ring has the same contraceptive efficacy as COCs with lower systemic EE exposure, more consistent serum EE levels and better cycle control, but more local adverse events resulting in higher discontinuation rates.     

Dose-finding study of a contraceptive ring releasing norethindrone acetate/ethinyl estradiol

A core design contraceptive vaginal ring (CVR) with average daily release of 650 mcg of norethindrone acetate (NA) and 30 mcg of ethinyl estradiol (EE) inhibited ovulation and controlled vaginal bleeding well, but caused some nausea. This study was designed to minimally alter the dose of steroid to see if nausea could be reduced without loss of contraceptive efficacy. This 30/650 CVR was compared to a CVR releasing 20 mcg of EE and 1000 mcg of NA (20/1000) and another releasing 25 mcg of EE and 650 mcg of NA (25/650) in 69 subjects. Twenty-three subjects using an oral contraceptive containing NA/EE served as controls. Ovulation inhibition was excellent and comparable to the OC for all formulations. The CVR provided better control of vaginal bleeding than did the OC. Side effects were equivalent to the OC with the exception of a slight increase in nausea in CVR users. Lipid changes and globulin increases were comparable to oral contraceptive users. The 20/1000 CVR increased sex hormone binding globulin-binding capacity less than the other two CVRs. The performance of the three CVRs was not significantly different, but the 25/650 showed a trend of reduced performance relative to the other two formulations.     

Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel

Background

This study compared the bleeding pattern, cycle control and safety of an oral contraceptive (OC) comprising estradiol valerate/dienogest (E2V/DNG; administered using a dynamic dosing regimen) with a monophasic OC containing ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG). E2V releases estradiol (E2), which is identical to endogenously produced 17β-estradiol.

Study design

This was a randomized, multicenter, double-blind, double-dummy trial lasting seven cycles in healthy women aged 18-50 years.

Results

Overall, 798 women were randomized and received allocated treatment (399 per group). There were significantly fewer bleeding/spotting days reported by women who received E2V/DNG than those who received EE/LNG [17.3±10.4 vs. 21.5±8.6, respectively, p<.0001, Reference Period 1 (Days 1-90); and 13.4±9.vs. 15.9±7.1, respectively, p<.0001, Reference Period 2 (Days 91-180)]. Through Cycles 1-7, the occurrence of scheduled withdrawal bleeding per cycle was 77.7-83.2% with E2V/DNG and 89.5-93.8% with EE/LNG (p<.0001 per cycle). The duration and intensity of scheduled withdrawal bleeding were reduced with E2V/DNG vs. EE/LNG. The incidence of intracyclic bleeding was similar with E2V/DNG (10.5%-18.6%) and EE/LNG (9.9%-17.1%) (p>.05 per cycle). No unintended pregnancies occurred with E2V/DNG, but there was one unintended pregnancy with EE/LNG. Adverse drug reactions occurred in 10.0% and 8.5% of women taking E2V/DNG and EE/LNG, respectively. Overall, 79.4% of women were satisfied with E2V/DNG and 79.9% with EE/LNG.

Conclusions

A novel OC composed of E2V/DNG is associated with an acceptable bleeding profile that is comparable to that of an EE-containing OC.     

Bleeding patterns of women using extended regimens of the contraceptive vaginal ring

INTRODUCTION: This prospective observational study evaluated the bleeding patterns of women using a vaginal ring releasing 120 microg of etonogestrel and 15 microg of ethinyl estradiol daily, over a continuous period of 84 days followed by 7 ring-free days. METHODS: The study enrolled 75 volunteers aged 18 to 37 years. Sixty-two (82.8%) recorded their menstrual cycles during 1 year. RESULTS: At the end of the study, 85.5% had adequate menstrual patterns (two to four bleeding episodes, none lasting 10 days or more, with a range of bleeding-free intervals not exceeding 17 days), 9.7% had infrequent bleeding, 1.6% reported prolonged bleeding episodes, 1.6% had frequent bleeding and 1.6% had irregular bleeding. CONCLUSION: Only 5 of the initial 75 patients discontinued the method due to bleeding. Among these 75 women, dissatisfaction with bleeding patterns was not a frequent reason given for discontinuation of the contraceptive vaginal ring.     

Safety and acceptability with the use of a contraceptive vaginal ring after surgical or medical abortion

OBJECTIVE: The study was conducted to determine if a contraceptive vaginal ring (CVR) is a safe and acceptable method of contraception when used in the proximate postabortion period following first-trimester surgical or medical abortion. METHODS: A CVR was inserted within 1 week following a medical or surgical abortion. Participants were followed up for 3 months to determine safety and acceptability. Safety was measured by the absence of signs of infection or serious adverse events. Acceptability was assessed by the CVR satisfaction survey, completed at the 3-month follow-up visit. RESULTS: Of 81 participants enrolled in the study, 69 (85%) completed the first-month follow-up visit, and 54 (67%) completed the final 3-month follow-up visit. There were no serious adverse events and no signs of infection on physical exam. Most adverse events were mild and not specifically related to the CVR. Related adverse events were those commonly associated with hormonal contraception use. Eighty-nine percent of participants chose to continue the CVR as their birth control method. CONCLUSION: The CVR is potentially safe and has high acceptability when used in the proximate postabortion period following a first-trimester abortion.     

Bone turnover markers in women participating in a dose-finding trial of a contraceptive vaginal ring releasing Nestorone and estradiol

ObjectiveTo evaluate changes in the bone turnover markers CTx and P1NP during 6 months' use of novel continuous contraceptive vaginal rings delivering Nestorone (NES) 200 mcg/day and three doses of estradiol (E2) (10, 20, and 40 mcg/day).Study designThis randomized trial enrolled 189 women who used two consecutive vaginal rings over 180 days. Frequent blood sampling permitted analysis of NES, E2, CTx and P1NP concentrations. The bone-turnover marker analyses included only women with complete sampling and excluded women with characteristics that might interfere with accurate measurement of bone markers such as afternoon sampling, poor ring compliance or recent pregnancy. We evaluated the change from baseline to 6 months in CTx and P1NP, stratified by ring dose and by average circulating E2 concentrations.ResultsOne hundred fifty-one women completed the study, and 82 women had complete data available for the bone marker analyses; the three dosage groups were balanced with regard to baseline characteristics. E2 concentrations remained low throughout treatment, regardless of which dose ring the participant used. Individual CTx changes from baseline averaged 27±56% (p<.01). Similarly, individual P1NP changes averaged 11±33% (p=.04). These increases were within the premenopausal reference ranges, and unrelated to treatment dose or to circulating E2 concentrations.ConclusionsThe low E2 dose of these rings was associated with low E2 concentrations and modest increases in serum bone turnover makers. Because we have only 6-month bone turnover markers and no direct evidence of bone loss or bone density change, these results must be interpreted with caution.ImplicationsNestorone, a 19-norprogesterone derivative, leads to complete ovarian suppression, which should yield excellent contraceptive effectiveness. To prevent potential adverse effects on bone, the NES contraceptive ring should be combined with higher doses of E2 than were assessed in this study.     

Effects of the contraceptive patch and the vaginal ring on bone metabolism and bone mineral density: a prospective, controlled, randomized study

Background

This study was conducted to compare the effects of the combined contraceptive vaginal ring releasing 15 mcg of ethinylestradiol (EE) and 120 mcg of etonorgestrel daily with the effects of the contraceptive patch, a transdermal system that delivers a daily dose of 20 mcg of EE and 150 mcg of norelgestromin on bone turnover and bone mineral density (BMD) in young fertile women.

Study Design

On the basis of a randomized, computer-generated list, 40 women desiring contraception were assigned to a 12-month treatment with a patch delivering a daily dose of 20 mcg of EE and 150 mcg of norelgestromin (Evra®, Janssen-Cilag, Italy) (Group A, n=20) or to a 12-month treatment with a vaginal ring releasing a daily dose of 15 mcg of EE and 120 mcg of etonorgestrel (NuvaRing®, Organon, Italy) (Group B, n=20). Twenty patients underwent no treatment and were used as healthy controls (Group C, n=20). At 3, 6, 9 and 12 months, serum and urinary calcium, osteocalcin and urinary pyridinoline (PYD) and deoxypyridinoline (D-PYD) levels were measured. At baseline and after 12 months, lumbar BMD was determined by dual-energy X-ray absorptiometry.

Results

In Groups A and B, urinary PYD and D-PYD at 6, 9 and 12 months were significantly reduced in comparison with basal values and Group C values (p<.05). In Groups A and B, serum calcium levels were significantly increased after 6 months. No significant difference was detected between Group A and Group B in urinary levels of PYD and D-PYD, in calcium levels and in osteocalcin levels. At 12 months, no significant difference was detected in spinal BMD values between the three groups and in comparison with basal values.

Conclusion

Both contraceptive systems exert a similar positive influence on bone turnover in young postadolescent women.     

Administration of the etonogestrel contraceptive implant on the day of mifepristone for medical abortion: a pilot study

Objective

We sought to determine satisfaction and continuation rates of the contraceptive implant when placed on the initial visit for first-trimester medical abortion.

Study Design

In this pilot study, we placed the implant within 15 min of mifepristone administration. We assessed satisfaction with implant placement timing, 1-year implant continuation and abortion completion.

Results

We enrolled 20 participants. Sixteen (80%) returned for follow-up, and all had complete abortion. At 1 year, of 16 participants contacted, 14 (87.5%) were satisfied with implant insertion timing, and 14 (87.5%) continued the implant.

Conclusions

Initiation of the contraceptive implant on the initial visit for medical abortion resulted in high satisfaction and continuation rates.

Implications

This pilot study provides important groundwork for future larger studies to assess initiation of the contraceptive implant on the day of mifepristone for medical abortion.     

Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, ‘Praneem polyherbal tablet’, in Pune, India

Acceptability and adherence in clinical trials of microbicides may possibly predict their acceptance by the community. In this study, we investigated the acceptability and adherence of Praneem polyherbal tablet, a candidate microbicide, among 100 HIV-uninfected participants of a Phase II randomised, double-blind, placebo-controlled trial in Pune, India, conducted between June 2004 and February 2006 involving 6 months of coitally-dependent product use. The relationship between five acceptability domains and adherence to product use during the study period was explored. Acceptability and adherence were assessed among 95 study participants completing all study follow-ups. One hundred percent adherence (product use during each sex act for the study period) was reported by 67 participants (70.5%). The majority of participants reported acceptability towards all product characteristics. Product odour was reported to be a concern both in the placebo and Praneem arms. Participants from the Praneem arm [adjusted odds ratio (AOR) = 3.8; 95% CI 1.4-10.8] and participants reporting lower acceptability for experience of product use during the sex act (AOR = 4.2; 95% CI 1.0-17.3) were more likely to have partial adherence. In conclusion, the study product was acceptable to the majority of participants. However, barriers to adherence attributable to undesirable sexual experiences need to be addressed.     

Acceptability of the long-term contraceptive levonorgestrel-releasing intrauterine system (Mirena): a 3-year follow-up study

This study investigated the long-term acceptability of a levonorgestrel-releasing intrauterine system (LNG-IUS) in 165 women after 6 and 36 months of use. Changes in menstrual bleeding pattern were experienced by 161 (98%) women, with a cessation or transient absence of menstruation occurring in 75 (47%) and 14 (9%) women, respectively. Amenorrhea was considered by most women (81%) as a positive change. The proportion of women with menstrual pain was reduced from 60% before use to 29% after 36 months of use with the LNG-IUS. Fear of an unwanted pregnancy became less widespread with duration of use and the device had no disturbing effects on the women or their partners during sexual intercourse. The number of women expressing that they were very satisfied with the LNG-IUS was 69% and 77% after six months and 36 months of use, respectively. LNG-IUS is a well-accepted contraceptive method, without negative influences on the sexual relationship between users and their partners, and is suitable for women requiring long-term reversible contraceptive protection.     

Factors affecting women's selection of a combined hormonal contraceptive method: the TEAM-06 Spanish cross-sectional study

BACKGROUND: Contraceptive efficacy and side effects are primary concerns of women when choosing a contraceptive method. STUDY DESIGN: This cross-sectional multicenter study was designed to assess the reasons for selecting the contraceptive pill, the skin patch or the vaginal ring in 9700 women, aged 18-49 years, who consulted their doctors for starting or re-initiating combined hormonal contraception. A self-administered questionnaire regarding the reasons for the selection made and for the refusal of the remaining two methods was completed. RESULTS: The vaginal ring showed the highest acceptance (46%) compared with the pill (39%) and the skin patch (15%), particularly in women aged 35-39 years. The ring and the skin patch were mainly preferred because of the lower probability of inadvertent omission (62% of cases), convenience, and monthly or weekly frequency of use. The pill was preferred because of its proven efficacy (60% of cases) and ease of use. The acceptance of the skin patch increased with age and the pill was mostly accepted only by women in the youngest age groups. CONCLUSIONS: Convenience, frequency of use and lower probability of inadvertent omission were the primary determinants of contraceptive choice rather than the women's profile.     

The effects of hormonal contraceptive use among women with viral hepatitis or cirrhosis of the liver: a systematic review

Background

This report evaluates the effects of hormonal contraceptive use among women with viral hepatitis or cirrhosis of the liver.

Methods

PubMed and Cochrane databases were searched from inception to June 2008 for publications that examined the use of hormonal contraceptives among women with viral hepatitis or cirrhosis of the liver.

Results

Six studies met the inclusion criteria. In one study of acute hepatitis, combined oral contraceptive (COC) use did not affect duration of hospitalization or successful disease resolution. The remainder of the studies examined chronic hepatitis or its sequelae. Women recovered from hepatitis experienced transaminase elevation with COC use which resolved after 4 weeks in one study or increased slightly over 6 months in another study. Hepatitis B virus carriers using COCs had similar transaminase levels as nonusing carriers over 6 months. Studies of chronic hepatitis C infection demonstrated no influence of COC use on progression or severity of liver fibrosis or development of hepatocellular carcinoma.

Conclusion

Data from one study suggest that COCs do not affect the course of acute hepatitis. Limited data from studies on chronic hepatitis or its sequelae suggest that COC use does not affect the rate of progression or severity of cirrhotic fibrosis, the risk of hepatocellular carcinoma in women with chronic hepatitis, or the risk of liver dysfunction in hepatitis B virus carriers.     

Modification of 24-h ambulatory blood pressure and heart rate during contraception with the vaginal ring: a prospective study

Background

Hypertension is recognized as a major risk factor for coronary, cerebral and renal vascular disease. Hormonal methods of contraception may increase the risk for cardiovascular events. We evaluated whether the combined hormonal contraceptive vaginal ring that releases 15-mcg ethinylestradiol and 120 mcg of etonogestrel each day influences 24-h ambulatory blood pressure.

Study Design

At baseline, ambulatory blood pressure was automatically monitored every 30 min for 41 h in 18 normotensive healthy women during their follicular phase (Days 3–6). Each subject was immediately treated with the vaginal ring for six cycles. Monitoring of ambulatory blood pressure was repeated in the last days of the sixth cycle of treatment.

Results

During the vaginal ring, a significant increase was observed for 24-h diastolic (2.75±5.13 mmHg; p=.03) and mean (2.69±5.35 mmHg; p=.048) blood pressure and for daytime diastolic (3.04±6.36 mmHg; p=.05) blood pressure. No variation was found in nighttime blood pressure. Heart rate increased in the 24-h period (3.39±5.85 beats/min; p=.025) and in the daytime (3.38±6.25 beats/min; p=.034) measurements.

Conclusions

In normotensive women, the vaginal ring slightly increases 24-h blood pressure and heart rate. The underlying mechanisms and the clinical impact of these slight modifications require further evaluation.     

Serum Nestorone and ethinyl estradiol levels, and ovulation inhibition in women using three different dosage combinations of a Nestorone progestogen-ethinyl estradiol contraceptive vaginal ring on a bleeding-signaled regimen

OBJECTIVES: This trial tested the hypothesis that menstrually signaled use of contraceptive vaginal rings ("rings") releasing low-dose combinations of Nestorone (NES) and ethinyl estradiol (EE) would reliably suppress luteal activity and ovulation, and prevent unintended pregnancy, while controlling the incidence of menstrual bleeding episodes and bleeding days. METHODS: Nestorone/ethinyl estradiol rings releasing 50/10, 50/20 and 150/15 mug/day were studied through 6 months. A ring was to be used continuously, until its removal was signaled by menstrual bleeding. Reinsertion was required 96 h after removal. Serum for NES, EE and progesterone were collected and assayed, and vaginal ultrasound scans were performed in three 5-week periods to examine luteal activity, follicular growth, ovulation and their correlates. In 10 subjects using the 150/15 ring, six samples were drawn in the 24-h period after ring removal to examine serum levels of NES and EE. RESULTS: One hundred sixty subjects at three doses provided blood samples. Median serum concentrations of NES and EE demonstrated dose ratios slightly below the nominal dose ratios expected. Serum NES concentrations declined 19-22% from weeks 3 to 25. Changes in EE levels depended on dose. Nestorone levels fell 81% by 24 h after ring removal and EE levels fell by 50%. Luteal activity was completely suppressed in 94-95% of cycles and in 90% of subjects. Three pregnancies occurred in subjects participating in this serum sampling study. CONCLUSION: Satisfactory serum levels of NES and EE, and a high level of ovulation suppression were achieved. Irregular ring use, however, permitted pregnancies to occur.