Austin Regional Clinic Physicians constantly tries to improve the care given to you and to all our patients. We are dedicated to offering unique options for our patients to help them reach ideal health goals. Part of this dedication involves making clinical research available. Clinical research makes it possible to discover the benefits, risks, and safety of both commercially-available and investigational medications.
Research standards are very strict to help make studies as safe as possible. Each study we conduct has already been reviewed by teams of government and research experts to minimize any study risks. Austin Regional Clinic has decided to be involved in this research study because we think it can potentially benefit our patients.
ARC is looking for patients who suffer from Uterne Fibroid issues. The purpose of the study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
If you’d like to see if you qualify, please contact our research team. You can call our ARC Clinical Research team at 512-225-5931, or fill out our Clinical Research interest form online.
What to Expect
Once the screening central lab and menstrual blood loss volume measured by Alkaline Hematin Method are received, all inclusion and exclusion criteria will be reviewed. If the eligibility is confirmed, the site will contact the subject to confirm her willingness to continue in the study. If the subject confirms, she will be randomized in a 1:1:1:1:1 ratio to one of five treatment groups.
At Week 24 visit, half of the subjects from the Placebo OBE2109 + Placebo E2/NETA arm will be switched to OBE2109 200 mg with add-back (E2 1 mg/NETA 0.5 mg) group while the other half will remain on placebo. This allocation will be pre-determined as part of the randomization and treatment will be continued up to Week 52.
We are currently seeking candidates for a paid clinical research study at Austin Regional Clinic Wilson Parke.
- Premenopausal women
- Heavy menstrual bleeding associated with uterine fibroids
- Oral medication alone and in combination with add-back therapy
# Visit's Required:
- The study duration will be approximately 85 weeks per subject. If a washout is required for Oral Contraceptive (OC) pill or other non-depot sex hormones, an additional period of up to 6 weeks is allowed between signing the informed consent and screening.
Request to Participate