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A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis

Studying bone health with long-term Relugolix use in women with fibroids or endometriosis.

Recruiting
18-50 years
Female
Phase 3

This study looks at how a medicine called relugolix combination tablet affects bone health in women over 4 years. It involves women with either uterine fibroids (non-cancerous growths in the uterus causing heavy periods) or endometriosis (tissue similar to the lining of the uterus grows outside it, causing pain). The study checks bone mineral density (BMD), which shows how strong your bones are, using a special X-ray every 6 months.

Women aged 18-50, not in menopause, with these conditions can join, but they must avoid pregnancy during the study using non-hormonal birth control. Those who have already taken the medicine for a year in another study may continue with this one for three more years. After 4 years of treatment or if they leave early, they will be checked for bone health for another year.

  • The study lasts up to 5 years (4 years treatment + 1 year follow-up).
  • Participants have check-ups every 6 months for bone health.
  • The study involves 1000 women, with no cost for the treatment.
Study details
    Uterine Fibroids
    Endometriosis

NCT05862272

Sumitomo Pharma Switzerland GmbH

12 October 2024

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