Unintended pregnancy rates differ according to combined oral contraceptive – results from the INAS-SCORE study

Barnett, Clare; Dinger, Jürgen; Minh, Thai Do; Heinemann, Klaas

doi:10.1080/13625187.2019.1629412

Cited by 10 publications

(2 citation statements)

References 17 publications

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“…These characteristics were shown to make NOMAC-E2 more 'forgiving' in the sense that contraceptive effectiveness is maintained even when pills are missed [16]. In support of these findings, results from the INAS-OC study showed the improved contraceptive effectiveness of a 24-day regimen of drospirenone when compared to a 21-day dosing schedule [9] and the INAS-SCORE study [24] showed a lower contraceptive failure rate of a multiphasic dienogest/E2-valerate preparation with a short 2-day hormone-free interval compared to LNG COCs with a 7-day hormone-free break.…”

Section: Discussionmentioning

confidence: 77%

Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study

Reed

Koro

DiBello

et al. 2021

The European Journal of Contraception & Reproductive Health

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Objective: To assess and compare the risk of unintended pregnancy in NOMAC-E2 users with levonorgestrel-containing COC (COC LNG ) users in clinical practice. Study design: In this observational study, new users 1 of NOMAC-E2 and COC LNG were recruited in Europe, Australia, and Latin America and followed for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (contraceptive failures per 100 women-years [WY]), crude hazard ratios (HR crude ) and adjusted hazard ratios (HR adj ). Results: Overall, 44,559 and 46,754 users were recruited to the NOMAC-E2 and COC LNG user cohorts, respectively. There were 64 unintended pregnancies in NOMAC-E2 users (0.15 per 100 WY; 95% CI, 0.11-0.19) and 200 in COC LNG users (0.41 per 100 WY; 95% CI, 0.35-0.47). The unintended pregnancy risk was statistically significantly lower in the NOMAC-E2 cohort (p<.0001) compared to the COC LNG user cohort. The HR adj of NOMAC-E2 vs COC LNG was 0.45 (95% CI, 0.34-0.60; adjusted for age, body mass index, gravidity, COC user status, education level). Conclusions: NOMAC-E2 demonstrated superior contraceptive effectiveness compared to COC LNG , likely due to the comparatively short hormone-free interval and possibly reinforced by the long half-life of NOMAC.

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Section: Discussionmentioning

confidence: 77%

Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study

Reed

Koro

DiBello

et al. 2021

The European Journal of Contraception & Reproductive Health

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“…3 In 2009 and 2010, an E2 valerate-based COC in a four-phase dosing regimen comprising varying combinations of E2 valerate and the progestin dienogest was launched in Europe and the United States. 4 The International Active Surveillance INAS-SCORE study (Safety of Contraceptives: Role of Estrogens), 5,6 a postauthorization safety study, evaluated the VTE risk of E2 valerate-dienogest compared with other marketed COCs and showed a trend toward a reduced VTE risk for E2 valerate-dienogest compared with first-line COCs containing ethinyl E2 in combination with levonorgestrel. In this pooled analysis, we further investigated this trend in a larger, realworld user population.…”

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confidence: 99%

Venous Thromboembolic Risk of Estradiol Valerate–Dienogest Compared with Ethinyl Estradiol–Levonorgestrel Combined Oral Contraceptives

Bauerfeind,

von Stockum,

Boehnke

et al. 2024

Obstetrics &Amp; Gynecology

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This pooled analysis compared the risk of venous thromboembolism (VTE) associated with combined oral contraceptives (COCs) containing estradiol (E2) valerate–dienogest with those containing ethinyl E2–levonorgestrel. Data were retrieved from two large, prospective, observational cohort studies. Propensity score subclassification was applied to balance baseline parameters between the COC user cohorts. Crude and adjusted hazard ratios (HRs) were calculated based on the extended Cox model. The pooled data set included 11,616 E2 valerate–dienogest users and 18,681 ethinyl E2–levonorgestrel users, contributing 17,932 and 29,140 women-years of observation, respectively. A significantly decreased VTE risk in E2 valerate–dienogest COCs compared with ethinyl E2–levonorgestrel COCs was observed (propensity score–stratified HR 0.46, 95% CI, 0.22–0.98). This pooled analysis expands data from a previous postauthorization safety study and provides valuable real-world safety information on the relative safety of current COCs.

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Evolución del estrógeno en la anticoncepción hormonal combinada: del etinilestradiol al estetrol pasando por el estradiol

Lete

2022

Clínica e Investigación en Ginecología y Obstetricia

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Unintended pregnancy rates differ according to combined oral contraceptive – results from the INAS-SCORE study

Cited by 10 publications

References 17 publications

Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study

Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study

Venous Thromboembolic Risk of Estradiol Valerate–Dienogest Compared with Ethinyl Estradiol–Levonorgestrel Combined Oral Contraceptives

Evolución del estrógeno en la anticoncepción hormonal combinada: del etinilestradiol al estetrol pasando por el estradiol

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