Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome

In brief

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Key facts

Study ID

NCT03951077

Run by

AbbVie

People needed

118

Starts

2019-08-12

Expected to finish

2021-02-10

Last updated by the study team

2022-06-08

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants with clinical diagnosis of PCOS.
• Participants with a body mass index (BMI) of 18.5 to 38 kg/m\^2 at time of Screening.

You may not qualify if…

• Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
• Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
• Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).

Where it is running

• Mobile, OBGYN P.C. /ID# 205574 — Mobile, Alabama, United States
• Medical Ctr for Clin Research /ID# 205694 — San Diego, California, United States
• UCSF Center for Reproductive Health /ID# 210836 — San Francisco, California, United States
• Avail Clinical Research /ID# 210873 — DeLand, Florida, United States
• University of FL Southside Women's Specialists /ID# 210872 — Jacksonville, Florida, United States
• Segal Institute for Clinical Research /ID# 205490 — North Miami, Florida, United States
• A Premier Medical Research of FL /ID# 215659 — Orange City, Florida, United States
• Virtus Research Consultant,LLC /ID# 205475 — Wellington, Florida, United States
• Comprehensive Clinical Trials LLC /ID# 205458 — West Palm Beach, Florida, United States
• Mount Vernon Clinical Res, LLC /ID# 205695 — Atlanta, Georgia, United States
• Bingham Memorial Hospital /ID# 205606 — Blackfoot, Idaho, United States
• Leavitt Womens Healthcare /ID# 205571 — Idaho Falls, Idaho, United States
• Womens Healthcare Assoc, DBA /ID# 211528 — Idaho Falls, Idaho, United States
• Sonora Clinical Research /ID# 205623 — Meridian, Idaho, United States
• Asr, Llc /Id# 207037 — Nampa, Idaho, United States
• PRN Professional Research Network of Kansas, LLC /ID# 205875 — Wichita, Kansas, United States
• Clinical Trials Management, LLC - Covington /ID# 211219 — Covington, Louisiana, United States
• Clinical Trials Management, LLC - Metairie /ID# 205494 — Metairie, Louisiana, United States
• Baltimore Suburban Health /ID# 205619 — Baltimore, Maryland, United States
• Johns Hopkins University /ID# 205617 — Baltimore, Maryland, United States
• Capital Women's Care - Frederi /ID# 210276 — Frederick, Maryland, United States
• NECCR Fall River LLC /ID# 205567 — Fall River, Massachusetts, United States
• Wayne State University Physician Group - Southfield /ID# 210245 — Southfield, Michigan, United States
• Private practice: Dr. Rex G. Mabey JR /ID# 211149 — Las Vegas, Nevada, United States
• Alabama Clinical Therapeutics /ID# 211498 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.