History
Elagolix/estradiol/norethindrone acetate was approved for medical use in the United States in May 2020.The efficacy of elagolix/estradiol/norethindrone acetate was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months. Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL). The primary endpoint was the proportion of women who achieved MBL volume less than 80 mL at the final month and 50% or greater reduction in MBL volume from the start of the study (baseline) to the final month. In the first study, 68.5% of participants who received elagolix/estradiol/norethindrone acetate achieved this endpoint (compared to 8.7% of participants who received placebo). In the second study, 76.5% of participants who received elagolix/estradiol/norethindrone acetate achieved this endpoint (compared to 10.5% of participants who received placebo).The approval of Oriahnn was granted to AbbVie Inc.

References
External links
"Elagolix". Drug Information Portal. U.S. National Library of Medicine. "Estradiol". Drug Information Portal. U.S. National Library of Medicine. "Norethindrone acetate". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02654054 for "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women" at ClinicalTrials.gov
Clinical trial number NCT02691494 for "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)" at ClinicalTrials.gov
Many medications can also affect the development of the fetus, as can alcohol, tobacco, and illicit drugs.See Environmental toxins and fetal development. See Drugs in pregnancy. Genetic mutations
Genetic mutations can cause a wide variety of fetal malformations, ranging from relatively mild cleft lips to severe and even fatal deformities. Infection
Maternal infection may be transmitted to the fetus; this is called a vertically transmitted infection. The fetus has a weak immune system, so infections that are relatively minor in adults can be very serious in a developing fetus. In addition, some studies suggest that maternal infections increase the risk of neurodevelopmental disorders, including schizophrenia, in the child. Intrauterine hypoxia
Intrauterine hypoxia, or oxygen deprivation in the womb, can cause serious brain damage in the fetus. It most commonly occurs because of damage to or malformation of the umbilical cord or placenta. Intrauterine hypoxia can cause brain damage, including cerebral palsy and other neurological and psychiatric disorders. Maternal health issues
Certain maternal health issues can cause birth injuries. Gestational diabetes can cause premature birth, macrosomia, or stillbirth. Pregnancy complications
Complications such as placenta previa, placental abruption,  Placenta accreta, Retained placenta, Placental insufficiency, Placental infarcts, anemia, and preeclampsia can limit the supply of oxygen and nutrients to the fetus, increasing the risk of birth defects. Severe cases may be fatal to the fetus. Common types of birth injury
Brachial plexus injury
The brachial plexus is the plexus of nerves that lies between the neck and axilla and controls the motion of the arm and hand.