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Gonadotropin-releasing hormone (GnRH) agonist

OBE2109 dose 1 (100mg) + Add-back for Uterine Fibroids (PRIMROSE 1 Trial)

Phase 3
Waitlist Available
Research Sponsored by ObsEva SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up last 28-day interval prior to week 24
Awards & highlights
Pivotal Trial

Summary

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Eligible Conditions
  • Menorrhagia
  • Uterine Fibroids

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last 28-day interval prior to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and last 28-day interval prior to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
Secondary study objectives
Amenorrhea
Number of days of uterine bleeding for each 28-day interval
Number of days of uterine bleeding for the last 28-day interval prior to Week 24
+1 more
Other study objectives
Adverse events
Bone Mineral Density (BMD)
Endometrial biopsy

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-backExperimental Treatment3 Interventions
Group II: OBE2109 dose 2 (200mg) + Add-backExperimental Treatment2 Interventions
Group III: OBE2109 dose 1 (100mg) + Placebo Add-backExperimental Treatment3 Interventions
Group IV: OBE2109 dose 1 (100mg) + Add-backExperimental Treatment3 Interventions
Group V: Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-backPlacebo Group4 Interventions
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo to match OBE2109
2017
Completed Phase 3
~1040
OBE2109
2016
Completed Phase 3
~1370
Placebo to match Add-back
2017
Completed Phase 3
~1040
Add-back
2017
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

ObsEva SALead Sponsor
13 Previous Clinical Trials
3,855 Total Patients Enrolled
~61 spots leftby Nov 2025
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