Last updated on July 2020

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: UTERINE FIBROID | Menorrhagia
  • Age: Between 18 - 100 Years
  • Gender: Female

Key Inclusion Criteria:

  • Premenopausal woman at screening.
  • Body Mass Index 18 kg/m2.
  • Menstrual cycles 21 days and 40 days.
  • Presence of uterine fibroids.
  • Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

Key Exclusion Criteria:

  • The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
  • History of uterus surgery that would interfere with the study.
  • The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.
  • Undiagnosed abnormal uterine bleeding.
  • Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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