Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Completed

Conditions studied: Uterine Fibroid, Endometriosis

In brief

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

Key facts

Study ID

NCT03744507

Run by

Myovant Sciences GmbH

People needed

660

Starts

2018-08-03

Expected to finish

2020-07-31

Last updated by the study team

2020-11-10

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Is a premenopausal female 18 to 50 years old
• By the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. Participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles.
• Has one of the following conditions:
• Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
• Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.
• Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.

You may not qualify if…

• Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
• Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
• Has a history of or currently has osteoporosis, or other metabolic bone disease
• Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
• Is currently pregnant or lactating, or intends to become pregnant during the study period

Where it is running

• Mesa — Mesa, Arizona, United States
• Huntington Beach — Huntington Beach, California, United States
• Palos Verdes Estates — Palos Verdes Estates, California, United States
• Denver — Denver, Colorado, United States
• United States, Colorado — Denver, Colorado, United States
• Aventura — Aventura, Florida, United States
• Jupiter — Jupiter, Florida, United States
• Loxahatchee — Loxahatchee Groves, Florida, United States
• Margate — Margate, Florida, United States
• Miami — Miami, Florida, United States
• Orange City — Orange City, Florida, United States
• Orlando — Orlando, Florida, United States
• Port St. Lucie — Port Saint Lucie, Florida, United States
• Sarasota — Sarasota, Florida, United States
• West Palm Beach — West Palm Beach, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• Decatur — Decatur, Georgia, United States
• Norcross — Norcross, Georgia, United States
• Oak Brook — Oak Brook, Illinois, United States
• Towson — Towson, Maryland, United States
• Canton — Canton, Michigan, United States
• Durham — Durham, North Carolina, United States
• Raleigh — Raleigh, North Carolina, United States
• Winston-Salem — Winston-Salem, North Carolina, United States
• Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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