A phase 1, multicentre, open-label study to evaluate ovarian follicular activity and hormone levels with an extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

Kroll, Robin; Seidman, Larry; Ricciotti, Nancy; Howard, Brandon; Weiss, Herman

doi:10.3109/13625187.2014.979282

Cited by 11 publications

(17 citation statements)

References 33 publications

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“…Effectiveness of extended-regimen 84/7 COC as a contraceptive method in the real world has been shown through significantly lower unintended pregnancy rates compared with 21/7 or 24/4 regimens, using an insurance claims database 25. Efficacy has been well demonstrated with the 84/7 LNG/EE regimen with continuous low-dose EE through effective unintended pregnancy prevention,22 and significantly decreased follicle stimulating hormone, estradiol, and developing follicles vs 7-day HFI regimens,19 as well as effective suppression of ovarian activity and ovulation inhibition 26. The safety of this extended-regimen COC is supported by studies showing no further accumulation of hormones,27 no unexpected changes in the endometrium or endometrial hyperplasia,28 no effect of cycle length on hemostatic biomarkers,29 and similar incidence rates of adverse events over 4 years of continuous use30 compared with the conventional 28-day cycle.…”

Section: Discussionmentioning

confidence: 99%

Cycle control with an extended-regimen oral contraceptive combining levonorgestrel and ethinyl estradiol that includes continuous low-dose ethinyl estradiol instead of the traditional hormone-free interval

Nappi¹,

Abascal²,

Hsieh

et al. 2017

IJWH

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PurposeTo evaluate scheduled and unscheduled bleeding and spotting over 1 year of treatment with 91-day extended-regimen combined oral contraception (COC) providing continuous low-dose ethinyl estradiol (EE) in place of the traditional 7-day hormone-free interval (HFI).Patients and methodsThis post hoc analysis of a multicenter, open-label, 1-year, Phase 3 study of extended-regimen COC with 30 µg EE/150 µg levonorgestrel (LNG) for 84 days and EE 10 µg for 7 days included 799 sexually active, adult women who completed at least one 91-day cycle of therapy. Subjects recorded bleeding and spotting episodes daily using electronic diaries. Logistic regression analyses are reported as ORs with 95% CIs.ResultsThere was a 10% increase (OR =1.102; 95% CI: 1.006–1.206) in the likelihood of reporting no scheduled bleeding for each additional 91-day cycle completed. From the third 91-day cycle, more than one fifth of women reported no scheduled bleeding (third cycle =23% [121/533]; fourth cycle =22% [97/446]). Among women who reported no scheduled bleeding at Cycle 1 (136/758 [18%]), ≥45% showed sustained lack of scheduled bleeding in later cycles. There were increases of 53% (OR =1.531; 95% CI: 1.393–1.683) and 31% (OR =1.307; 95% CI: 1.205–1.418) in the likelihood of reporting 0 to ≤6 days vs >6 days of unscheduled bleeding and spotting, respectively, for each additional 91-day cycle. By Cycle 2, more than 80% of women reported no unscheduled bleeding or ≤6 days of unscheduled bleeding during each 91-day cycle.ConclusionImproved cycle control with decreased bleeding over time was shown during extended-regimen COC with 30 µg EE/150 µg LNG for 84 days and continuous low-dose EE instead of the traditional 7-day HFI. Women considering this regimen should be informed that those who complete at least one 91-day COC cycle will likely experience less bleeding/spotting in future cycles.

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Section: Discussionmentioning

confidence: 99%

Cycle control with an extended-regimen oral contraceptive combining levonorgestrel and ethinyl estradiol that includes continuous low-dose ethinyl estradiol instead of the traditional hormone-free interval

Nappi¹,

Abascal²,

Hsieh

et al. 2017

IJWH

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“…10 Women should be made aware of the potential for pregnancy immediately after completion of COC in order to avoid unintended pregnancy.…”

Section: Discussion/conclusionmentioning

confidence: 99%

Differences in reporting Pearl Indices in the United States and Europe: Focus on a 91-day extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

Luzar-Stiffler²,

Giljanovic

et al. 2015

The European Journal of Contraception & Reproductive Health

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Background Regulatory agencies in the United States (US) and Europe differ in requirements for defining pregnancies after the last dose of oral contraceptive, sometimes resulting in discrepant Pearl Indices (PIs) for the same product despite identical clinical data. This brief report highlights one such example, a 91-day extended-regimen combined oral contraceptive (COC). Methods The US- and European-based PI methodologies were compared for a 91-day extended-regimen COC consisting of 84 days of active levonorgestrel/EE 150 μg/30 μg tablets, followed by 7 days of EE 10 μg tablets in place of placebo. Conclusions At the times of approval of the 91-day extended-regimen COC in the US and Europe, the requirements for defining ‘on-treatment’ pregnancies differed (14-day vs. 2-day rule, respectively). This difference resulted in a higher PI in the US- vs. European-based calculation (1.34 and 0.76, respectively). The differences in the PI should not be interpreted as the extended-regimen COC being less effective in preventing pregnancy in the US compared with Europe.

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“…The ovarian activity rate for the entire 91-day period was 2.9 % and ovulation was suppressed in 97.1 % of cycles during treatment with Seasonique Ò [13]. Additionally, progesterone levels were generally low (1.8-3.1 nmol/L) during treatment (vs. 29.7 nmol/L during the pre-treatment cycle).…”

Section: Contraceptive Effectsmentioning

confidence: 90%

“…In another study (n = 35), ovulation was detected in 0 out of 35 cycles during the first 28-day interval, in 2.9 % of cycles in the second 28-day interval and in 5.7 % of cycles in the final 35-day interval [13]. The ovarian activity rate for the entire 91-day period was 2.9 % and ovulation was suppressed in 97.1 % of cycles during treatment with Seasonique Ò [13].…”

Section: Contraceptive Effectsmentioning

confidence: 93%

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Extended-Cycle Levonorgestrel/Ethinylestradiol and Low-Dose Ethinylestradiol (Seasonique®): A Review of Its Use as an Oral Contraceptive

Burness

2015

Drugs

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A 91-day extended-cycle oral contraceptive (OC) consisting of levonorgestrel/ethinylestradiol 150/30 µg for 84 days and ethinylestradiol 10 µg for 7 days (Seasonique(®)) has recently been approved for the prevention of pregnancy in adult women in the EU. This regimen allows for a reduction in the number of withdrawal bleeding episodes to four per year, compared with 13 episodes per year with conventional 28-day regimens. Seasonique(®) was effective in preventing pregnancy in a large (n = 1006), noncomparative trial of healthy, sexually active women. In this trial, the overall Pearl index (pregnancies per 100 woman-years of use) in women aged 18-35 years (n = 621) was 0.76 and the Pearl index for method-failure (compliant use) was 0.26. Scheduled (withdrawal) bleeding and/or spotting remained fairly constant over time, with a mean of 2 days of bleeding and 1 day of spotting per each 91-day cycle. Unscheduled bleeding and unscheduled spotting was highest during the first few cycles of use and decreased thereafter. Seasonique(®) was generally well tolerated, with a tolerability profile in line with that expected for OCs. Seasonique(®) extends the contraceptive options currently available to women, particularly in those who desire fewer withdrawal bleeding episodes.

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A phase 1, multicentre, open-label study to evaluate ovarian follicular activity and hormone levels with an extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

Abstract: The 91-day extended-regimen COC with low-dose EE supplementation was found to be effective in suppressing ovarian activity and inhibiting ovulation and was well tolerated. Return to ovulation was rapid, occurring within approximately one month after discontinuation of COC.

Cited by 11 publications

References 33 publications

Cycle control with an extended-regimen oral contraceptive combining levonorgestrel and ethinyl estradiol that includes continuous low-dose ethinyl estradiol instead of the traditional hormone-free interval

Cycle control with an extended-regimen oral contraceptive combining levonorgestrel and ethinyl estradiol that includes continuous low-dose ethinyl estradiol instead of the traditional hormone-free interval

Differences in reporting Pearl Indices in the United States and Europe: Focus on a 91-day extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation

Extended-Cycle Levonorgestrel/Ethinylestradiol and Low-Dose Ethinylestradiol (Seasonique®): A Review of Its Use as an Oral Contraceptive

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