Ulipristal acetate prevents ovulation more effectively than levonorgestrel: analysis of pooled data from three randomized trials of emergency contraception regimens

Background

The days just prior to ovulation are the most crucial for emergency contraception (EC) efficacy. Ulipristal acetate (UPA) and levonorgestrel's (LNG) capacity to inhibit follicular rupture have never been compared directly at this time of the cycle.

Study Design

Raw data from three pharmacodynamics studies with similar methodology were pooled to allow direct comparison of UPA, LNG and LNG+meloxicam's ability to prevent ovulation when administered orally in the advanced follicular phase, with a leading follicle of ≥18 mm.

Results

Forty eight LNG-treated (1.5 mg) cycles, 31 LNG (1.5 mg) + meloxicam (15 mg), 34 UPA (30 mg) cycles and 50 placebo cycles were compared. Follicle rupture was delayed for at least 5 days in 14.6%, 38.7%, 58.8% and 4% of the LNG-, LNG+meloxicam-, UPA- and placebo-treated cycles, respectively. UPA was more effective than LNG and placebo in inhibiting follicular rupture (p=.0001), while LNG, when administered at this time of the cycle, was not different than placebo. The addition of meloxicam improved the efficacy of LNG in preventing follicular rupture (p=.0292 vs. LNG; p=.0001 vs. placebo; non-significant vs. UPA). UPA was effective in preventing rupture in the 5 days following treatment, even when administered at the time of the luteinizing hormone (LH) surge (UPA 79%, LNG 14% and placebo 10%). None of the treatments were effective when administered on the day of the LH peak. The median time from treatment to rupture was 6 days during the ulipristal cycles and 2 days in the placebo and LNG/LNG+meloxicam cycles (p=.0015).

Conclusion

Although no EC treatment is 100% effective in inhibiting follicular rupture when administered in the late follicular phase, UPA is the most effective treatment, delaying ovulation for at least 5 days in 59% of the cycles. LNG is not different from placebo in inhibiting follicular rupture at this advanced phase of the cycle. No treatment was effective in postponing rupture when administered on the day of LH peak.     

The COX-2 inhibitor meloxicam prevents pregnancy when administered as an emergency contraceptive to nonhuman primates

Objective

Cyclooxygenase-2 (COX-2) inhibitors reduce prostaglandin synthesis and disrupt essential reproductive processes. Ultrasound studies in women demonstrated that oral COX-2 inhibitors can delay or prevent follicle collapse associated with ovulation. The goal of this study was to determine if oral administration of a COX-2 inhibitor can inhibit reproductive function with sufficient efficacy to prevent pregnancy in primates.

Study Design

The COX-2 inhibitor meloxicam (or vehicle) was administered orally to proven fertile female cynomolgus macaques using one emergency contraceptive model and three monthly contraceptive models. In the emergency contraceptive model, females were bred with a proven fertile male once 2±1 days before ovulation, returned to the females' home cage, and then received 5 days of meloxicam treatment. In the monthly contraceptive models, females were cocaged for breeding with a proven fertile male for a total of 5 days beginning 2±1 days before ovulation. Animals received meloxicam treatment (1) cycle days 5–22, or (2) every day, or (3) each day of the 5-day breeding period. Female were then assessed for pregnancy.

Results

The pregnancy rate with meloxicam administration using the emergency contraception model was 6.5%, significantly lower than the pregnancy rate of 33.3% when vehicle without meloxicam was administered. Pregnancy rates with the three monthly contraceptive models (75%–100%) were not consistent with preventing pregnancy.

Conclusions

Oral COX-2 inhibitor administration can prevent pregnancy after a single instance of breeding in primates. While meloxicam may be ineffective for regular contraception, pharmacological inhibition of COX-2 may be an effective method of emergency contraception for women.

Implications

COX-2 inhibitors can interfere with ovulation, but the contraceptive efficacy of drugs of this class has not been directly tested. This study, conducted in nonhuman primates, is the first to suggest that a COX-2 inhibitor may be effective as an emergency contraceptive.     

A randomized study on pharmacodynamic effects of vaginal rings delivering the progesterone receptor modulator ulipristal acetate: research for a novel estrogen-free,method of contraception

Objective

To determine whether a 3-month contraceptive vaginal ring (CVR) delivering ulipristal acetate (UPA) can inhibit ovulation in 90% of cycles.

Study Design

This was a randomized dose-finding parallel group clinical trial. Fifty-five healthy women with normal ovulation at baseline were randomized to receive a low-dose (1500 μg/day) or a high-dose (2500 μg/day) UPA-CVR for two consecutive 12-week treatment periods, followed by a recovery cycle. A subgroup of women received levonorgestrel (LNG) 1.5 mg orally twice (at the end of both 12-week ring periods) or once (at the end of the 24-week treatment). The primary outcome was ovulation suppression assessed by transvaginal ultrasound and hormone levels. Secondary outcomes included endometrial safety and bleeding patterns.

Results

All subjects showed normal ovulation at baseline and recovery. Ovulation suppression was seen in 81.8% (95% CI: 73.3%, 88.5%) and 86.1% (95% CI: 78.1%, 92%) of treatment cycles with low and high-dose, respectively. Benign progesterone receptor modulator associated endometrial changes (PAEC) were seen during treatment; 78.8% at week 24, but resolved at recovery cycle. A few cases of heavy bleeding occurred near the end of the 24-week treatment, but a single dose of LNG every 12 weeks reduced the increase in endometrial thickness during the second treatment period and prevented excessive bleeding.

Conclusion

The 3-month UPA-CVR may become an effective long-acting, user-controlled estrogen-free contraceptive. The greatest suppression of ovulation was seen with the 2500-μg/day ring.

Implications

The 3-month CVR delivering UPA 2500 μg/day can become an effective user-controlled estrogen-free contraceptive method. Benign PAEC during treatment returns to normal after discontinuation. The prevention of occasional excessive withdrawal bleeding, either by a progestin or by using higher UPA levels to increase follicle suppression may permit prolonged treatment.     

Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation

Background

The contraceptive efficacy of emergency contraceptive pills containing levonorgestrel (LNG-EC) has been estimated in most previous studies by judging the day of ovulation from presumptive menstrual cycle data, thus providing poorly reliable estimates.

Methods

In the present study, the efficacy of LNG-EC was determined in 393 cycles by dating ovulation on the basis of reliable hormonal and ovarian parameters validated by a database constructed in a separate study. In addition, the efficacy was determined separately for cycles in which LNG-EC was given before or after ovulation.

Results

For the 148 women who had sexual intercourse during the fertile days, the overall accumulated probability of pregnancy was 24.7, while altogether 8 pregnancies were observed. Thus, the overall contraceptive efficacy of LNG-EC was 68%. Among the 103 women who took LNG-EC before ovulation (days −5 to −1), 16 pregnancies were expected and no pregnancy occurred (p<.0001). Among the 45 women who took LNG-EC on the day of ovulation (day 0) or thereafter, 8 pregnancies occurred and 8.7 were expected (p=1.00). These findings are incompatible with the inhibition of implantation by LNG-EC in women. The same cases were also analyzed using the presumptive menstrual cycle data, and important discrepancies were detected between the two methods.

Conclusion

The efficacy of LNG-EC has been overestimated in studies using presumptive menstrual cycle data. Our results confirm previous similar studies and demonstrate that LNG-EC does not prevent embryo implantation and therefore cannot be labeled as abortifacient.     

Efficacy and safety of an ascending-dose,extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive

Objective

To evaluate the efficacy and safety of an ascending-dose, extended-regimen (ADER) combined oral contraceptive consisting of levonorgestrel (LNG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 42 days, LNG 150 mcg/EE 25 mcg for 21 days, LNG 150 mcg/EE 30 mcg for 21 days and EE 10 mcg for 7 days.

Study Design

This was a multicenter, open-label, phase 3, single-arm study. Sexually active women aged 18–40 years were enrolled and received ADER for up to 1 year (4 consecutive 91-day cycles). Participants kept diaries to record adherence, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index and the life-table method; safety and tolerability were assessed through reported adverse events (AEs).

Results

A total of 3701 women were enrolled and 2144 completed the study. The Pearl Index was 3.19 [95% confidence interval (CI), 2.49–4.03], based on 70 pregnancies that occurred after ADER initiation and ≤ 7 days after the last LNG/EE or EE-only pill in women aged 18–35 years, excluding cycles in which another contraceptive method was used. Life-table pregnancy rate was 2.82% (95% CI, 2.23%–3.57%) for all users aged 18–35 years. Unscheduled bleeding/spotting decreased with increasing EE doses within each cycle and decreased after cycle 1. No unexpected AEs or changes in laboratory parameters were reported.

Conclusion

This study demonstrated that ADER effectively prevented pregnancy with a favorable safety and tolerability profile.     

Impact of body mass index on suppression of follicular development and ovulation using a transdermal patch containing 0.55-mg ethinyl estradiol/2.1-mg gestodene: a multicenter,open-label,uncontrolled study over three treatment cycles

Background

Body mass index (BMI) may influence ovulation inhibition resulting from transdermal hormone delivery. Investigation of this effect is important given the high prevalence of obesity in the US.

Study Design

This open-label, uncontrolled, Phase 2b trial stratified 173 women (18–35 years) according to three BMI groups (Group 1, n=56, ≤ 30 kg/m²; Group 2, n=55, > 30 kg/m² and ≤ 35 kg/m²; and Group 3, n=47, > 35 kg/m²). Women used a contraceptive patch containing 0.55-mg ethinyl estradiol (EE) and 2.1-mg gestodene (GSD). The EE/GSD patch was used weekly for three 28-day cycles (one patch per week for 3 consecutive weeks followed by a 7-day, patch-free interval), and its effect on ovulation was assessed by the Hoogland score, a composite score that comprises transvaginal ultrasound and estradiol (E₂) and progesterone levels every 3 days in Cycles 2 and 3. Evaluation of pharmacokinetic parameters was a secondary aim of the study, and blood samples for analytic determination of EE, GSD and sex hormone-binding globulin were taken during the pretreatment cycle, Cycle 2 and Cycle 3. Compliance was assessed using diary information and serum drug levels.

Results

In the per-protocol set, there were only six ovulations during the study, and no participant ovulated in both study cycles. One ovulation occurred in Group 1, three in Group 2 and two in Group 3. Ovulation inhibition was unaffected by BMI; in all groups, most participants had Hoogland scores of 1 or 2 (i.e., follicle-like structures < 13 mm: Group 1, ≤ 30 kg/m², 80.0% in Cycle 2, 85.7% in Cycle 3; Group 2, > 30 kg/m² and ≤ 35 kg/m², 61.4% in Cycle 2, 75.0% in Cycle 3; Group 3, > 35 kg/m², 78.0% in Cycle 2, 72.5% in Cycle 3). Serum levels of follicle-stimulating hormone, luteinizing hormone, E₂ and progesterone were similar between groups. Body weight had a limited effect on EE clearance that was unlikely to be clinically relevant.

Conclusion

The EE/GSD patch provided effective ovulation inhibition, even in women with higher BMI.

Implications

This is the largest-to-date study of physiologic endpoints and found no clinically important differences in ovarian suppression among obese and normal-weight users of the EE/GSD contraceptive patch, thus providing reassurance that obese women can achieve the same high level of contraceptive protection as normal-weight users.     

Examining the role of oral contraceptive users as an experimental and/or control group in athletic performance studies

Background

This study was conducted to examine the effect of oral contraceptives on endogenous reproductive hormone levels in order to assess the suitability of oral contraceptive users as experimental and/or control groups in human performance studies.

Study Design

Ninety-five females who were taking a variety of oral contraceptives (2 types and 11 brands) were recruited. A single blood sample was analysed for endogenous concentrations of oestradiol and progesterone.

Results

There were significant differences (p<.05) in circulating oestradiol and progesterone as a result of oral contraceptive type and brand. Overall, oral contraceptive use resulted in low levels of oestradiol and progesterone and large variation in hormone concentration when multiple brands were analysed together.

Conclusion

This study indicates that future studies should employ a single pill type and brand when using oral contraceptive users as either a control or experimental group and that comparison between oral contraceptive users as a control group and the early follicular phase of the menstrual cycle as an experimental group should be reconsidered.     

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.     

Efficacy of fennel and combined oral contraceptive on depot medroxyprogesterone acetate-induced amenorrhea: a randomized placebo-controlled trial

Objectives

We aimed to determine the efficacy of fennel and low-dose combined oral contraceptive (LD-COC) on inducing menstrual bleeding and method continuation in women using depot medroxyprogesterone acetate (DMPA) who had no menstrual bleeding within the previous 45 to 140 days.

Study design

In this double-blind double-dummy trial, 78 married women referred to public health centers in Hamadan, Iran, who complained of menstrual cessation induced by DMPA were randomly assigned into fennel, LD-COC or placebo groups with an allocation ratio of 1:1:1. All participants received two fennel or placebo capsules and one placebo or LD-COC pill daily for 21 days. We evaluated menstrual bleeding using the Higham pictorial chart within 40 days following initiating intervention. Data were analyzed using chi-square or analysis of variance.

Results

There was no loss to follow-up. Significantly more women in the fennel (73%) and LD-COC (81%) groups experienced menstrual bleeding compared to the placebo (19%) group [relative risk (RR) 3.1, 95% confidence interval (CI) 1.6 to 6.2; RR 4.2, 95% CI 1.9 to 9.4, respectively]. Mean amount of menstrual bleeding among those who experienced menstruation was significantly higher in the fennel group (21 cc) than both the LD-COC (14 cc) and placebo (12 cc) groups. Also, women using fennel (73%) and LD-COC (65%) were significantly more likely than those using placebo (31%) to have subsequent DMPA injection [RR 2.5 (95% CI 1.3 to 4.9) and RR 2.0 (95% CI 1.1 to 3.7), respectively].

Conclusions

Fennel and LD-COC can resolve DMPA-induced amenorrhea and increase continuation rate of this contraceptive method.     

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.     

Effects of low-dose mifepristone administration in two different 14-day regimens on the menstrual cycle and endometrial development: a randomized controlled trial

Background

This study was conducted to evaluate the effects of treatment with mifepristone 5 mg given every day or every other day for 14 days, starting 15 days after menses started for endometrial development.

Study Design

Ten women recruited to the study were given mifepristone 5 mg beginning 15 days after initiation of menses. In Group A, five women were administered mifepristone every day for three cycles; in Group B, five women were administered mifepristone every other day for three cycles. The effects on the menstrual cycle and endometrial development were investigated.

Results

Following these treatments with mifepristone 5 mg, there was slight suppression of ovulation in both treatment cycles compared with control cycles. The follicular phase in subsequent cycles was prolonged after daily treatment with mifepristone, which was not observed after administration every other day. In addition, continuous treatment increased progesterone receptor (PR) expression and reduced leukemia inhibitory factor (LIF) expression in the endometrial epithelium.

Conclusion

Treatment with low-dose mifepristone every day or every other day starting 15 days after initiation of menses retards endometrial development and impairs endometrial receptivity but has minor effects on the menstrual cycle.     

Understanding women's desires for contraceptive counseling at the time of first-trimester surgical abortion

Objective

The objective was to investigate whether or not women presenting for a first-trimester surgical abortion want to discuss contraception on the day of their procedure.

Study Design

Between October 2012 and January 2013, an anonymous self-administered survey was distributed to women receiving first-trimester surgical abortions at four northern California family planning clinics. The survey obtained demographic information about each woman and inquired about her desire for contraceptive counseling during her appointment. Results were analyzed using both univariate and multivariable regression analyses to assess trends in responses related to desire for contraceptive counseling based on demographic and other variables.

Results

Of the 199 respondents, 64% reported that they did not want to talk to a counselor or doctor about contraception on the day of their abortion. About half of the women (52%) who did not want to discuss contraception indicated they already knew what they wanted for pregnancy prevention. Of the 25% who reported that they did want to discuss contraception, the most important topic desired from the counseling was identification of methods that were easier to use than what they used previously.

Conclusion

The majority of women seeking first-trimester surgical abortion may not desire additional information about contraception on the day of the procedure.

Implications Statement

This study demonstrates that a significant proportion of women may not want contraceptive counseling on the day of a planned surgical abortion.     

Characteristics of Kenyan women in a prospective cohort study who continue using subdermal contraceptive implants at 12 months

Objective

Subdermal contraceptive implant continuation has not been well studied in Africa. We conducted a secondary data analysis to compare baseline characteristics of Kenyan women who continued to use the subdermal implant at 12 months to those who did not.

Study Design

Kenyan women aged 18–24 years who presented to a family planning clinic for short-acting hormonal contraception were offered a two-rod subdermal implant instead. Participants were followed for 12 months after initiation of their contraceptive method. Statistical analysis included Pearson's chi-square or Fisher's exact tests for comparisons of proportions. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to determine factors associated with continuation.

Results

Eighty-six (89%) of the 97 women who chose the implant were followed for 12 months. Of these women, 68 (79%) continued to use the implant. None of the factors we examined had a statistically significant association with continued use of the implant. Duration of intended use was the only strong factor; 83% of women with 3 + years of need continued using the implant, compared to 56% of those with shorter needs (Risk ratio = 1.48, 95% CI = 0.94–2.31). No substantive continuation differences were found when comparing other participant characteristics including months with their current partner, personal desire and partner preference for future children, previous use of modern birth control and other factors.

Conclusion

High implant continuation rates were noted regardless of previous use of modern birth control, partner preference for children or baseline concern for menstrual change.

Implications

Contraceptive use in Africa continues to focus on short-acting contraceptives despite the proven superior efficacy of long-acting reversible contraceptives in other settings. The high subdermal implant continuation among Kenyan women in this prospective study, regardless of baseline characteristics, supports the need for increasing access and future research in this population.     

Characteristics of scheduled bleeding manipulation with combined hormonal contraception in university students

Background

There is a lack of information concerning the decision factors and sources of information influencing women who purposefully deviate from the prescribed use of their combined hormone contraceptives to exert elective control of their scheduled bleeding.

Study Design

A self-administered email survey of scheduled bleeding practices and beliefs was distributed to 11,900 female students at the University of Oregon. Assessment of survey participant characteristics, scheduled bleeding manipulation features and attitudes and knowledge toward hormonal contraception was analyzed.

Results

Of 1719 respondents to the survey, 1374 (79.9%) reported using combined hormonal contraception currently or recently. Approximately 17% of these women altered their scheduled bleeding pattern by deviating from package instructions. Of these, 50% indicated they delayed or skipped their scheduled bleeding for convenience or personal choice. Within this group, 47% of women indicated they learned to modify their scheduled bleeding from health care professionals, while 30% indicated such knowledge was obtained from family or friends. Characteristics that decreased the likelihood of this practice included being of Asian race, use of hormonal contraceptive for bleeding cycle regulation, following a regular exercise program, and personal preference for a monthly cycle.

Conclusions

The majority of university females who choose to modify their scheduled bleeding cycle with combined hormonal contraceptives do so for convenience rather than to avoid menstrual symptoms, and many learn from nonmedical sources. There is some disparity between the preferences of menstruation frequency and actual scheduled bleeding pattern behaviors, suggesting potential for improvement in patient education.     

Immediate versus delayed initiation of the contraceptive patch after abortion: a randomized trial

Background

Immediate start of the contraceptive patch has not been studied in women after surgical abortion.

Study Design

Women presenting for surgical abortion who had chosen the transdermal patch for contraception were randomized to either delayed start of the patch (beginning the Sunday after their abortion) or immediate start (directly observed application of the patch in the clinic). Subjects were contacted at 2 and 6 months to assess contraceptive use.

Results

Two hundred ninety-eight women were randomized, and the follow-up rate was 71% at 2 months and 53% at 6 months. Method continuation did not differ by timing of initiation. At 2 months, 71% in the delayed-start group and 74% in the immediate-start group were using the patch [p=.6, with a difference of 3.1%, 95% confidence interval (CI)=−17.2% to +11.2%]. At 6 months, 55% in the delayed-start group and 43% in the immediate-start group were using the patch (p=.13, with a difference of 11.9%, 95% CI=−19.2% to +34%).

Conclusion

Immediate initiation of the contraceptive patch after surgical abortion was not associated with increased use of patch at 2 or 6 months.     

Delayed pregnancy testing and second-trimester abortion: can public health interventions assist with earlier detection of unintended pregnancy?

Background

Delayed pregnancy testing has been associated with presentation for abortion in the second trimester. Little is known about acceptability of potential interventions to hasten pregnancy recognition.

Study design

A total of 592 women presenting for abortion at six clinics in the United States completed surveys on contraceptive use, risk behavior, timing of first pregnancy test and interest in interventions to speed pregnancy recognition and testing.

Results

Forty-eight percent of women presenting for second-trimester abortion delayed testing until at least 8 weeks. In multivariate analysis, women who often spotted between periods had higher odds of delaying pregnancy testing [odds ratio (OR) 2.7, 95% confidence interval (CI) 1.04–6.94]. Women who often missed periods had higher odds of second-trimester abortion (OR 2.1, 95% CI 1.34–3.13). The majority (64%) of women were not aware of a fertile time in the menstrual cycle; these women had higher odds of second-trimester abortion (OR 2.0, 95% CI 1.21–3.37). Ninety-four percent of women expressed interest in at least one potential intervention to help recognize pregnancy earlier.

Conclusions

While there was near-universal interest in earlier pregnancy recognition, no single proposed intervention or scenario was endorsed by the majority. Improving sexual health awareness is an important consideration in future efforts to expedite pregnancy testing.

Implications

We found near-universal interest in earlier pregnancy recognition, though no single proposed intervention or scenario garnered majority support. Based on our findings, the concept of improving sexual health awareness through education should be incorporated in the development of future strategies to hasten recognition of unintended pregnancy.     

Effect of a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) in women with menstrually-related migraine (MRM)

Background

Combined hormonal contraception might worsen migraine in sensitive women, especially during the free-hormone interval, and raise concerns about the vascular risk. The characteristics of a contraceptive pill containing estradiol valerate/dienogest (E2V/DNG) might be of potential benefit in women with menstrually related migraine (MRM) who choose to use oral contraception for birth control.

Study design

This was a prospective diary-based pilot study. Thirty-two women (age > 35 years) [n= 18 who had never used combined oral contraceptives (COCs) and n= 14 who had previously used COCs] diagnosed with MRMs according to the International Headache Society criteria were included. During the observational period, women filled in a diary with the clinical characteristics of migraine attacks. After a three-cycle run-in period, each subject received a COC containing E2V/DNG (Qlaira®/Natazia®; Bayer HealthCare, Berlin, Germany) administered using an estrogen step-down and progestogen step-up approach. Follow-up evaluations were scheduled at the last cycle of run-in and at the third and sixth cycles of treatment.

Results

The number of migraine attacks was significantly reduced at the third (p<.001) and sixth cycles (p<.001) in comparison with the run-in period. A similar result was evident for the duration (p<.001 at the third and p<.001 at the sixth cycle) as well as for the severity of head pain (p<.001 at the third and p<.001 at the sixth month). Indeed, a significantly lower number of analgesics were used at the third cycle (p<.001) in comparison with baseline, and a further decrease was evident at the sixth cycle (p<.001) in comparison with the third cycle of E2V/DNG use. Interestingly, duration and severity of head pain were significantly correlated with the number of days of dysmenorrhea at the third cycle (r= .89, p=.000 and r= .67, p=.02; respectively) and at the sixth cycle (r= .76, p=.000 and r= .62, p=.04; respectively) in women without complete remission of menstrual cramps during the study period.

Conclusions

The present diary-based pilot study indicates that the use of a pill containing EV2/DNG for six cycles has a positive effect in women with MRM and suggests an association between dysmenorrhea with COCs use as a potential feature of refractory head pain.     

Contraceptive method selection by women with inflammatory bowel diseases: a cross-sectional survey

Objective

Women with inflammatory bowel diseases (IBDs) utilize contraception at a lower rate than the general population. We sought to identify factors associated with contraceptive use and selection of more effective methods in IBD patients at risk for unintended pregnancy.

Study Design

An online survey was distributed to women with IBD in January 2013. Contraceptive methods were categorized by effectiveness and associations with use explored by demographics, disease characteristics and reproductive goals.

Results

A total of 162 respondents were analyzed: 62% had Crohn’s disease and 38% ulcerative colitis. Mean age was 31 (range 20–45), 97% identified as White, and 53% were nulliparas. Seventy-four percent were currently using IBD medications. A quarter of participants (23%) used no contraception, 17% used highly effective methods, 41% used short-term hormonal methods, and 19% chose barrier/behavioral methods. Prior IBD-related surgery, biologic therapy use and low education attainment were associated with no contraception use. Of contraceptive users, age, parity, insurance status, IBD surgery and prior immunomodulator use were associated with highly effective method selection.

Conclusions

A quarter of women with IBD at risk for pregnancy in this study population reported no contraceptive method use. Higher levels of IBD activity influence contraceptive use and method selection, which could guide future patient and provider educational interventions.

Implications

Pregnancy planning is important for women with inflammatory bowel diseases to avoid adverse outcomes in a disease-poor state. Use of contraception assists in avoidance of unintended pregnancy. IBD characteristics are targets for educational interventions to improve uptake of highly effective contraceptive methods.     

Contraceptive adherence among HIV-infected women in Malawi: a randomized controlled trial of the copper intrauterine device and depot medroxyprogesterone acetate

Objective

To evaluate contraceptive adherence to the copper intrauterine device (Cu-IUD) and the injectable depot medroxyprogesterone acetate (DMPA) among women with HIV in Lilongwe, Malawi.

Methods

We randomized 200 HIV-infected women on highly active antiretroviral therapy (HAART) to either the Cu-IUD or DMPA and followed these women prospectively, evaluating adherence and factors associated with nonadherence.

Results

There was no difference in contraceptive adherence: 68% of Cu-IUD and 65% of DMPA users were adherent at 48 weeks. Receiving first-choice contraceptive was not associated with adherence. Women commonly cited partner's disapproval as an indication for discontinuation. Women who experienced heavy menstruation and first-time contraceptive users were more likely to be nonadherent. Among ongoing users at study conclusion, 95% were happy with their method, and 98% would recommend their method to a friend.

Conclusion

Contraceptive adherence between the Cu-IUD and DMPA was similar at 1 year. With similar adherence and similar high rates of satisfaction among users of both methods at 1 year, the Cu-IUD offers a hormone-free alternative to DMPA.

Implications

Adherence to the Cu-IUD and DMPA is similar at 1 year among HIV-infected women on HAART in a randomized controlled trial. Despite high method satisfaction, partner disapproval and heavy bleeding contribute to reduced adherence. Receiving a method that differs from participant's first-choice method did not influence adherence.     

Evaluation of a volunteer community-based health worker program for providing contraceptive services in Madagascar

Background

Madagascar recently scaled up their volunteer community health worker (CHW) program in maternal health and family planning to reach remote and underserved communities.

Study design

We conducted a cross-sectional evaluation using a systematic sample of 100 CHWs trained to provide contraceptive counseling and short-acting contraceptive services at the community level. CHWs were interviewed on demographics, recruitment, training, supervision, commodity supply, and other measures of program functionality; tested on knowledge of injectable contraception; and observed by an expert while completing five simulated client encounters with uninstructed volunteers. We developed a CHW performance score (0–100%) based on the number of counseling activities adequately met during the client encounters and used multivariable linear regression to identify correlates of the score.

Results

CHWs had a mean performance score of 73.9% (95% confidence interval [CI]: 70.3–77.6%). More education, more weekly volunteer hours, and receiving a refresher training correlated with a higher performance score. We found no other associations between measures of the components previously identified as essential for effective CHW programs and performance score.

Conclusions

Although areas of deficiency were identified, CHWs proved capable of providing high-quality contraception services.