Last reviewed · How we verify
Loestrin
At a glance
| Generic name | Loestrin |
|---|---|
| Also known as | Ethinyl estradiol (EE) and norethindrone (NET) |
| Sponsor | ViiV Healthcare |
| 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 should not be used by w omen who are over 35 years of age and smoke [ see Contraindications (4) ] . WARNING : CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribi
Common side effects
- Nausea
- Vomiting
- Gastrointestinal symptoms (abdominal cramps and bloating)
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Headache
- Breast tenderness
- Edema
- Change in weight
- Migraine
- Depression
Serious adverse events
- Thrombophlebitis
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Arterial thromboembolism
- Mesenteric thrombosis
- Retinal thrombosis
- Hepatic adenomas or benign liver tumors
- Budd-Chiari syndrome
Key clinical trials
- Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
- A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
- Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation (NA)
- Ovulation Incidence in Oral Contraceptive Users (PHASE3)
- A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants (PHASE1)
- Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448) (PHASE3)
- A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants (PHASE1)
- A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Loestrin CI brief — competitive landscape report
- Loestrin updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI