HAILEY 1.5/30
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HAILEY 1.5/30 (HAILEY 1.5/30).
Combination oral contraceptive containing ethinyl estradiol and desogestrel. Ethinyl estradiol suppresses gonadotropin release via negative feedback on the hypothalamic-pituitary axis; desogestrel, a progestin, inhibits ovulation and alters cervical mucus and endometrial receptivity.
| Metabolism | Ethinyl estradiol undergoes hepatic metabolism primarily via CYP3A4; desogestrel is rapidly metabolized to its active metabolite etonogestrel via hydroxylation and dehydrogenation, further metabolized via CYP2C9 and CYP3A4. |
| Excretion | Approximately 40% renal (as metabolites), 32% fecal (as metabolites), and <1% unchanged in urine. |
| Half-life | Terminal elimination half-life of ethinyl estradiol is 13-27 hours (mean 17 hours); for norgestimate, active metabolite norelgestromin has half-life 12-30 hours (mean 19 hours). Steady state reached after 7-14 days. |
| Protein binding | Ethinyl estradiol: ~98% bound to albumin; norelgestromin: ~99% bound to albumin and SHBG. |
| Volume of Distribution | Ethinyl estradiol: 2.3-4.0 L/kg; norelgestromin: 2.0-3.5 L/kg. Indicates extensive tissue distribution. |
| Bioavailability | Oral: Ethinyl estradiol 40-55% (first-pass metabolism); norelgestromin: ~80% (as metabolite of norgestimate). |
| Onset of Action | Oral: Contraceptive effect begins after 7 days of continuous dosing; maximum effect after 1 cycle. |
| Duration of Action | Contraceptive protection persists for 24 hours per daily dose; missed doses >24 hours increase pregnancy risk. |
One tablet (ethinyl estradiol 0.03 mg, levonorgestrel 0.15 mg) orally once daily at the same time each day for 21 days, followed by 7 placebo tablets. For continuous cycling, may take active tablets daily without placebo.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Not studied in severe impairment, but estrogen metabolites may accumulate; use caution. |
| Liver impairment | Contraindicated in acute liver disease or severe hepatic impairment (Child-Pugh C). For mild to moderate (Child-Pugh A or B), use is not recommended due to altered hormone clearance; if used, monitor liver function and consider lower estrogen dose. |
| Pediatric use | Postmenarchal adolescents: Same adult dosing (one tablet daily). Safety and efficacy not established in premenarchal girls. |
| Geriatric use | Not indicated for postmenopausal women; contraindicated after menopause due to increased risk of cardiovascular events. No specific geriatric dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HAILEY 1.5/30 (HAILEY 1.5/30).
| Breastfeeding | CHCs may reduce milk production and composition. Small amounts of synthetic estrogen and progestin are excreted in breast milk. M/P ratio not specifically reported for this combination; ethinyl estradiol M/P ratio approximately 0.02-0.05. Use during lactation is generally not recommended, especially in early postpartum period. Alternative contraception should be considered. |
| Teratogenic Risk | FDA Pregnancy Category X. Combined hormonal contraceptives (CHCs) are contraindicated in pregnancy. First trimester exposure is associated with a low risk of fetal malformations; however, CHCs should be discontinued if pregnancy occurs. Second and third trimester exposure may increase risks of fetal adverse outcomes, including but not limited to congenital anomalies and fetal demise. Use is not recommended at any trimester. |
■ FDA Black Box Warning
Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use combination oral contraceptives should be strongly advised not to smoke.
| Serious Effects |
["Active or history of venous thromboembolism","Cerebrovascular disease","Coronary artery disease","Valvular heart disease with complications","Thrombogenic valvulopathies","Major surgery with prolonged immobilization","Diabetes with vascular involvement","Uncontrolled hypertension","Active liver disease","Known or suspected pregnancy","Breast cancer or other estrogen-sensitive neoplasia","Heavy smoking (≥15 cigarettes/day) and age ≥35"]
| Precautions | ["Increased risk of thromboembolic disorders","Cigarette smoking increases cardiovascular risk","Elevated blood pressure","Gallbladder disease","Hepatic neoplasia","Carbohydrate and lipid effects","Ocular lesions","Headache/migraine","Bleeding irregularities","Depression"] |
Loading safety data…
| Fetal Monitoring | Monitor blood pressure monthly, assess for thromboembolic symptoms (leg pain, chest pain, dyspnea), monitor liver function and signs of hepatic adenoma. Rule out pregnancy before initiation and at any missed menses. No specific fetal monitoring required if pregnancy occurs; standard prenatal care advised. |
| Fertility Effects | CHCs prevent ovulation and implantation; fertility returns promptly after discontinuation. No permanent adverse effects on fertility. Post-use, normal ovulatory cycles typically resume within 1-3 months. |