Pooled analysis of bleeding profile, efficacy and safety of oral oestradiol valerate/dienogest in women aged 25 and under

Jeffrey T. Jensen, Johannes Bitzer, Rossella E. Nappi, Christiane Ahlers, Ralf Bannemerschult, Susanne Parke
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception · 2020 · vol. 25(2) , pp. 98–105 · doi:10.1080/13625187.2020.1731734 · PMID:32162555 · W3011418156
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This pooled analysis found that women aged 25 and under experienced similar bleeding, efficacy, and safety profiles with oral estradiol valerate/dienogest compared to older women.

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Abstract

Purpose: To evaluate differences in key outcomes between younger and older women receiving the oral contraceptive oestradiol valerate/dienogest (E2V/DNG).Methods: We conducted a pooled post hoc analysis of primary data from 12 studies of E2V/DNG, stratified by age (≤25 [n = 1309] and >25 [n = 2132] years). Outcomes included safety, efficacy, bleeding profile and hormone-withdrawal-associated symptoms (HWAS). Bleeding and HWAS analyses are also presented for women aged ≤20 years (n = 362). Discontinuations were considered a proxy for patient satisfaction.Results: Results were generally similar for younger and older women. The percentage of women aged ≤25 and >25 years experiencing intracyclic bleeding did not differ between groups (13.4% and 12.8% at cycle 12, respectively), with similar results in women aged ≤20 years (12.7%, cycle 12). Rates of withdrawal bleeding were very similar in women aged ≤25 and >25 years (78.5% and 78.9%, respectively, cycle 12). We also found a similar adjusted Pearl index in the two age groups (0.45 vs 0.57, respectively), similar rates of AEs and HWAS and no difference in discontinuations.Conclusions: Women aged ≤25 and >25 years have a similar experience with an E2V/DNV oral contraceptive, supporting this as an appropriate contraceptive option in younger and older women.

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MeSH descriptors

Contraceptives, Oral, Combined Estradiol Nandrolone Uterine Hemorrhage Adolescent Adult Age Factors Clinical Trials, Phase II as Topic Clinical Trials, Phase III as Topic Contraceptives, Oral, Combined Contraceptives, Oral, Combined Contraceptives, Oral, Combined Drug Combinations Estradiol Estradiol Estradiol Estradiol Female Humans Middle Aged

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