EUCTR2021-000452-19-LV
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
ConditionsTreatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment of heavy menstrual bleeding associated with uterine fibroids.
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Enrollment
- 147
- Status
- Active, not recruiting
- Last Updated
- 3 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
Similar Trials
Active, not recruiting
Phase 1
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2Treatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]EUCTR2021-000452-19-BGObsEva S.A.400
Active, not recruiting
Phase 1
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2Treatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]EUCTR2021-000452-19-PLObsEva S.A.400
Active, not recruiting
Phase 1
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2Treatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]EUCTR2021-000452-19-HUObsEva S.A.400
Active, not recruiting
Phase 1
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2EUCTR2021-000452-19-ROObsEva S.A.400
Completed
Not Applicable
ong-term observation on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefectureJPRN-UMIN000025818SAPPORO HOLDINGS Ltd.170