New Data Show NEXTSTELLIS® Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives
March 06, 2021 at 15:00 PM EST
RALEIGH, N.C., March 6, 2021 /PRNewswire/ -- Mayne Pharma announced today new data showing treatment with NEXTSTELLIS®,1 a novel, investigational combined oral contraceptive (COC) containing drospirenone (DRSP) and estetrol (E4), resulted in limited changes in endocrine markers, including lower increases in hormone binding globulins, compared with COCs based on ethinyl-estradiol (EE), the synthetic estrogen used in all but one of the marketed COCs. The data was presented at the annual meeting of the International Society for the Study of Women's Sexual Health (ISSWSH), held virtually in the U.S. from March 5-7.
Historically, some COCs have been associated with a decrease in circulating androgensi and increases in hormone binding globulins.ii These endocrine changes can result in hormonal imbalance and have been associated with side effects such as acne, excess facial and body hair, or changes in libido.iii
"When prescribing COCs, practitioners must have a good understanding of how these therapies may impact other hormones in the body in order to make an informed prescribing decision for their patients," said Andrew London, M.D., Assistant Professor of OB/GYN at The Johns Hopkins School of Medicine. "Based on our findings, treatment with DRSP/E4 has limited effects on some of these endocrine parameters compared to the tested EE-containing products, giving DRSP/E4 a different and potentially favorable endocrine profile compared to those EE-based COCs."
In a phase 2 study, titled "Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone," the changes from the baseline serum concentration of various endocrine and liver protein markers at cycle 3 and 6 were determined in subjects receiving NEXTSTELLIS or a COC formulation containing EE combined with either levonorgestrel (LNG/EE) or drospirenone (DRSP/EE). Comparative findings include:
"This exciting new data adds to the solid safety and tolerability profile of NEXTSTELLIS and the growing body of clinical evidence that this unique combination with a new form of estrogen, may be a promising novel oral contraceptive option for women," said Scott Richards, CEO, Mayne Pharma.
About Mayne Pharma
Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialized in numerous products that continue to be marketed around the world.
NEXTSTELLIS® is a registered trademark of a third party.
Contact: Karen Dombek, email@example.com, 908-234-9900
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SOURCE Mayne Pharma