Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception
Completed
Bayer
Phase 3
2013-08-01
The objective of this study is to compare the red blood cell (RBC) and plasma concentrations
of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus
levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.
Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before
and in the first few weeks of pregnancy has been shown to reduce certain types of birth
defects. This is important for women who may become pregnant following discontinuation of
oral contraception. Information about any side effects that may occur will also be collected.
Sponsor Type for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Sponsor
Trials
Industry
1
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0
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Last updated: May 25, 2026
ecutive summary
Drosperinone/ethinyl estradiol/levomefolate calcium (a 24/4 oral contraceptive class product) has late-stage clinical development that is typically driven by line extensions (new dose regimens, stratified populations, formulations), while competitive dynamics largely hinge on generic/OTC-adjacent oral contraceptive entry timing, label differentiation, and patent estate resilience around levomefolate calcium use and formulation/process IP. Market projection depends on (1) U.S. exclusivity and patent-expiration calendar, (2) biosafety and tolerability claims that sustain differentiation, and (3) how quickly authorized generics and at-large generics pressure price.
However, no drug-specific clinical-trial registry data, FDA product/Orange Book listing, or patent/expiration dataset is included in the provided prompt. Without those concrete inputs, a complete, accurate clinical-trials update and market/patent-based projection cannot be produced under required data constraints.
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