orlistat + ethinyl estradiol + norethindrone acetate + lifestyle modification

This combination treatment approach, developed and studied by the Milton S. Hershey Medical Center, is a multi-component preconception intervention designed for obese infertile women with polycystic ovary syndrome (PCOS). Investigated in the Phase 2 OWL-PCOS trial, the regimen integrates pharmacological therapy with intensive lifestyle changes. It specifically consists of the lipase inhibitor orlistat (60 mg three times daily), a continuous low-dose oral contraceptive pill (Loestrin 1/20, containing ethinyl estradiol and norethindrone acetate), and a lifestyle modification program involving caloric restriction (meal replacements), exercise, and behavioral counseling. The mechanism of action is dual-pronged: the oral contraceptive suppresses ovarian androgen production to treat hyperandrogenism, while the lifestyle intervention and orlistat promote weight loss to improve insulin sensitivity. This combined strategy aims to optimize the metabolic and endocrine environment prior to ovulation induction, thereby increasing cumulative ovulation and live birth rates.

Brand names

Loestrin 1/20

Other names

OWL-PCOS combination therapypreconception lifestyle intervention plus oral contraceptives