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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000452-19-PL

Enrollment

400

Registered

2021-04-09

Start date

2021-05-21

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of heavy menstrual bleeding associated with uterine fibroids. MedDRA version: 21.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864

Interventions

Product Name: linzagolix Product Code: OBE2109 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: linzagolix Current Sponsor code: OBE2109 Other descriptive name: OBE2109 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Bulgaria, Czechia, Hungary, Latvia, Poland, Romania, Ukraine, United States

Contacts

Public ContactClinical Trial Information

ObsEva S.A.

clinicaltrials@obseva.ch+41225523840

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026