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Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
This combination oral contraceptive prevents pregnancy by suppressing ovulation through progestin and estrogen activity, while methyltetrahydrofolate supplementation reduces neural tube defect risk.
This combination oral contraceptive prevents pregnancy by suppressing ovulation through progestin and estrogen activity, while methyltetrahydrofolate supplementation reduces neural tube defect risk. Used for Contraception with reduced risk of neural tube defects.
At a glance
| Generic name | Drospirenone/Ethinylestradiol/Methyltetrahydrofolate |
|---|---|
| Sponsor | Bayer |
| Drug class | Oral contraceptive with folate supplementation |
| Target | Progesterone receptor, estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Women's Health |
| Phase | Phase 3 |
Mechanism of action
Drospirenone is a fourth-generation progestin with antimineralocorticoid activity that inhibits the LH surge necessary for ovulation, while ethinylestradiol is a synthetic estrogen that suppresses FSH and stabilizes the endometrium. The addition of methyltetrahydrofolate (the active form of folic acid) provides periconceptional folate supplementation to reduce the risk of neural tube defects in case of contraceptive failure or planned pregnancy.
Approved indications
- Contraception with reduced risk of neural tube defects
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Venous thromboembolism
Key clinical trials
- Efficacy and Safety Study for an Oral Contraceptive Containing Folate (PHASE3)
- Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate (PHASE1)
- Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin) (PHASE1)
- Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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