Estelle® (estetrol and drospirenone) (E4/DRSP)The FDA is reviewing Mayne Pharma’s Estelle as a combination product for pregnancy prevention. Estelle is composed of 15mg estetrol (E4) and 3mg of drospirenone (DRSP). Estetrol is a native estrogen that has minimal impact on liver cells and metabolic pathways. Estelle is seeking approval based on Phase 3 clinical studies that met its primary endpoint of contraceptive efficacy. This was measured by the number of on-treatment pregnancies per 100 women per 12 months of exposure among women ages 16 to 35 years of age.5 Mayne Pharma claims Estelle is more environmentally friendly compared to alternatives currently on the market because E4 creates smaller environment concentrations in aquatic environment (low as 10ng/L) compared to synthetic estrogen ethinylestradiol (EE2) which is considered to be a strong environmental endocrine disruptor that could accumulate in living organisums.6 Similar products include EE/DRSP combination oral contraceptives.
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