ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 400

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to describe BMD changes for up to 24 months following previous treatment with placebo or linzagolix at 100 mg or 200 mg alone or with ABT for at least 20 weeks in the context of the PRIMROSE 1 and PRIMROSE 2 studies. ;Secondary Objective: Secondary objectives include evaluation of BMD changes from baseline BMD in the PRIMROSE 1 and PRIMROSE 2 studies.;Primary end point(s): The primary endpoint is the change in lumbar spine (L1-L4), femoral neck, and total hip BMD at 12, 18 and 24 months from the end of treatment in PRIMROSE 1 and PRIMROSE 2 study participants.;Timepoint(s) of evaluation of this end point: 12, 18 and 24 months from the end of treatment in PRIMROSE 1 and PRIMROSE 2

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline to each scheduled assessment in lumbar spine (L1-L4), femoral neck, and total hip BMD in PRIMROSE 1 and PRIMROSE 2 study participants.;Timepoint(s) of evaluation of this end point: 12, 18 and 24 months from Day 1 DXA of the studies PRIMROSE 1 and PRIMROSE 2

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