Last reviewed · How we verify
Levora
At a glance
| Generic name | Levora |
|---|---|
| Also known as | Hormonal oral contraceptive |
| Sponsor | Agile Therapeutics |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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, including LEVORA 0.15/30-28, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1) ].
Common side effects
- Nausea
- Breast tenderness
- Vomiting
- Abdominal pain
- Cramps
- Bloating
- Change in menstrual flow
- Change in weight
- Change in appetite
- Breast pain
- Breast enlargement
- Breast secretion
Serious adverse events
- Mesenteric thrombosis
- Serious cardiovascular adverse events
- Vascular events
- Liver disease
- Hypertension
- Gallbladder disease
- Carcinoma of the cervix
- Anaphylactic/anaphylactoid reactions
- Budd-Chiari syndrome
- Hemolytic uremic syndrome
Key clinical trials
- A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (PHASE1)
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR (PHASE2)
- A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (PHASE1)
- A Study of Elenestinib in Healthy Adult Female Participants (PHASE1)
- A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (PHASE1)
- Validating and Assessing Reliability
- Role of Estrogen on Skeletal Outcomes in FHA (PHASE2)
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 |