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

Phase 1

• Conditions: Treatment of heavy menstrual bleeding associated with uterine fibroids.; MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-000452-19-PL
• Lead Sponsor: ObsEva S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-09
• Last Update Posted: 13 September 2021

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