EUCTR2016-004059-53-LV
Active, not recruiting
Phase 1
A Phase 3, multicentre, randomized, double-blind, placebo controlled study investigating the efficacy and safety of daily oral administration of OBE2109 alone and in combination with add-back therapy for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. - Primrose 2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ObsEva SA
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Premenopausal woman at screening
- •Body Mass Index \= 18 kg/m2
- •Menstrual cycles \= 21 days and \= 40 days prior to screening
- •Presence of uterine fibroids
- •Heavy menstrual blood loss for the first eight days of two menstrual periods assessed at screening using the alkaline hematin method
- •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 500
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •The subject is pregnant or breast\-feeding or is planning a pregnancy within the duration of the study
- •History of uterus surgery that would interfere with the study
- •The subject’s condition is so severe that she will require surgery within 6 months regardless of the treatment provided
- •Undiagnosed abnormal uterine bleeding
- •Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease
Outcomes
Primary Outcomes
Not specified
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