Studied in more than ONE type of patient

Studied in a broad range of women, including patients like yours

Selected patient characteristics at baseline in ELARIS UF-1 and UF-2 (N=790)1-7†

Fibroid Location

  • Submucosal
  • Intramural
  • Subserosal

Primary Fibroid


79.6 cm3


1-1081.5 cm3

Primary fibroid volume defined as largest fibroid identified by ultrasound.

Uterine Volume


500.0 cm3


71.6-3347.9 cm3

A uterus that is 14-16 weeks in size is approximately 355-460 cm3.



42.4 years


25-53 years

MBL Volume


239.7 mL


83.8-1207.1 mL

1 cup=237 mL

MBL=menstrual blood loss



33.6 kg/m2


18.8-61.5 kg/m2

Comprised of


Black or African American women1



Hispanic or Latina women4

How was ORIAHNN studied?

In two 6-month Phase 3 pivotal studies (ELARIS UF-1 AND UF-2) including premenopausal women aged 25-53 with heavy menstrual bleeding associated with uterine fibroids and in an additional
6-month extension study (UF-EXTEND), which did not include a placebo arm1,8,9

Evaluated across
multiple endpoints

Primary endpoint in ELARIS UF-1, UF-2, and UF-EXTEND1,8,9:

The proportion of women who attained both menstrual blood loss (MBL) volume less than 80 mL at the Final Month‡§ and 50% or greater reduction in MBL volume from baseline to the Final Month‡§

Ranked secondary endpoints in ELARIS UF-1 and UF-21,8,9:

  • Change in MBL volume from baseline to Months 1, 3, 6, and Final Month
  • Number and percentage of women with Suppression of Bleeding (defined as no bleeding, but spotting allowed) during the Final Month of treatment
  • Number and percentage of women with baseline hemoglobin ≤10.5 g/dL who saw an increase of >2 g/dL at Month 6

The same secondary endpoints were studied in the extension study (ELARIS UF-EXTEND), but were not ranked

ORIAHNN met the primary endpoint and all 6 ranked secondary endpoints in its pivotal studies9

For primary fibroid volume only, N=778.

Final Month in ELARIS UF-1 and UF-2 is defined as the last 28 days before and including the last treatment visit date or the last dose date.

§Final Month in ELARIS UF-EXTEND is defined as the last 28 days before and including the last dose date.