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Drospirenone Ethinyl estradiol
COCs reduce pregnancy risk mainly by preventing ovulation.
At a glance
| Generic name | Drospirenone Ethinyl estradiol |
|---|---|
| Sponsor | AGUNCO Obstetrics and Gynecology Centre |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Combined oral contraceptives (COCs) primarily work by suppressing ovulation, which prevents the release of an egg from the ovaries and thus reduces the chance of fertilization.
Approved indications
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning Women over 35 years old who smoke should not use drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
Common side effects
- headache/migraine
- menstrual irregularities
- nausea/vomiting
- breast pain/tenderness
- menstrual irregularities
- nausea
- headache
- breast tenderness
- fatigue
- irritability
- decreased libido
- increased weight
Key clinical trials
- Anxiety and Depression in Adolescent PCOS (NA)
- A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants (PHASE1)
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding (NA)
- A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies (PHASE1)
- Effect of Drospirenone-Ethinyl Estradiol (20microgram vs 30 Microgram) on Free Androgen Index in PCOS (NA)
- Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS (NA)
- Continuous Versus Cyclical OCP Use in PCOS (PHASE4)
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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