CLINICAL TRIALS PROFILE FOR DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

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All Clinical Trials for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01902264 ↗	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.

Clinical Trial Conditions for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

Condition Name

Condition Name for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Intervention	Trials
Contraception	1

Condition MeSH

Condition MeSH for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Intervention	Trials

Clinical Trial Locations for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

Trials by Country

Trials by Country for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Location	Trials
Mexico	1

Clinical Trial Progress for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

Clinical Trial Phase

Clinical Trial Phase for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Clinical Trial Phase	Trials
Phase 3	1

Clinical Trial Status

Clinical Trial Status for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

Sponsor Name

Sponsor Name for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Sponsor	Trials
Bayer	1

Sponsor Type

Sponsor Type for DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Sponsor	Trials
Industry	1

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.