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Updated: Feb 4, 2026
06:51
Ovariectomy and 17β-estradiol Replacement in Rats and Mice: A Visual Demonstration
Published on: June 7, 2012
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Venous Thromboembolism Risk Associated With Relugolix-estradiol-norethisterone Acetate Combination Therapy.
Jonathan Douxfils1,2,3, Marie Didembourg1,2, Lorraine Maitrot-Mantelet4
1Clinical Pharmacology and Toxicology Research Unit, Namur Research Institute for Life Sciences, Faculty of Medicine, University of Namur, 5000 Namur, Belgium.
Journal of the Endocrine Society
|February 2, 2026
Summary
Relugolix combined therapy for uterine conditions shows a low venous thromboembolism (VTE) risk, comparable to traditional oral contraceptives. Careful patient selection and ongoing surveillance are recommended for optimal safety.
Area of Science:
- Pharmacology
- Gynecology
- Thrombosis Research
Background:
- Relugolix, an oral GnRH antagonist, treats uterine myomas and endometriosis.
- Concerns exist regarding venous thromboembolism (VTE) risk with relugolix combined with estradiol (E2) and norethisterone acetate (NETA).
Purpose of the Study:
- Evaluate the thrombotic risk of relugolix combined therapy (relugolix-CT).
- Assess risk based on pharmacological data, clinical trials, and regulatory reviews.
Main Methods:
- Reviewed pivotal trials (LIBERTY, SPIRIT) and regulatory reports (EMA, FDA).
- Analyzed real-world safety data, focusing on hemostatic effects and VTE risk.
Main Results:
- Relugolix monotherapy causes minor decreases in coagulation factors.
- E2 and NETA mitigate hypoestrogenic effects; clinical data show no significant VTE increase.
- E2-based regimens have lower thrombotic risk than ethinylestradiol-based therapies.
Conclusions:
- Relugolix-CT VTE risk appears lower than traditional combined oral contraceptives.
- Essential to select patients carefully, especially those with thrombotic risk factors.
- Continued real-world surveillance is crucial for refining the safety profile.
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