EUCTR2021-000452-19-RO
Active, not recruiting
Phase 1
A long-term follow-up study to assess bone mineral density in subjects with uterine fibroids completing the Phase 3 studies of linzagolix, PRIMROSE 1 or PRIMROSE 2 - PRIMROSE 3
ObsEva S.A.0 sites400 target enrollmentApril 21, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ObsEva S.A.
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject must provide written informed consent.
- •2\. The subject completed at least 20 weeks of treatment in PRIMROSE 1 or PRIMROSE 2 and underwent an end\-of\-treatment DXA scan
- •3\. The subject is enrolled within 24 months from the last treatment administration in PRIMROSE 1 or PRIMROSE 2\.
- •4\. The subject is willing and able to comply with the requirements of the study protocol for the duration of the PRIMROSE 3 study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 400
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. The subject is pregnant.
- •2\. The subject can not have her scans done on the same DXA machine type as used for the end\-of\-treatment DXA scan in PRIMROSE 1 or PRIMROSE 2
- •3\. The subject is currently taking part in a clinical trial or has been administered any experimental drug since completion of PRIMROSE 1 or PRIMROSE 2\.
- •4\. The subject has any condition that, in the opinion of the Investigator, constitutes a risk or a contraindication to the participation of the subject in this study, or that could interfere with the study objectives, conduct or assessments.
Outcomes
Primary Outcomes
Not specified
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