Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 1)

ObsEva

Status and phase: Completed; Phase 3

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Treatments: Drug: Placebo to match Add-back; Drug: Placebo to match OBE2109; Drug: OBE2109; Drug: Add-back

Study type: Interventional

Funder types: Industry

Identifiers

NCT03070899

16-OBE2109-008

Details and patient eligibility

About

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.

Full description

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids.

Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Enrollment: 526 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Premenopausal woman at screening.
• Body Mass Index ≥ 18 kg/m2.
• Menstrual cycles ≥ 21 days and ≤ 40 days.
• Presence of uterine fibroids.
• Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

Key Exclusion Criteria:

• The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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526 participants in 5 patient groups, including a placebo group

OBE2109 dose 1 (100mg) + Placebo Add-back

Experimental group

Treatment:

Drug: Placebo to match Add-back

Drug: Placebo to match OBE2109

Drug: OBE2109

OBE2109 dose 1 (100mg) + Add-back

Experimental group

Treatment:

Drug: Placebo to match OBE2109

Drug: OBE2109

Drug: Add-back

OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back

Experimental group

Treatment:

Drug: Placebo to match Add-back

Drug: OBE2109

Drug: Add-back

OBE2109 dose 2 (200mg) + Add-back

Experimental group

Treatment:

Drug: OBE2109

Drug: Add-back

Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back

Placebo Comparator group

Description:

At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.

Treatment:

Drug: Placebo to match Add-back

Drug: Placebo to match OBE2109

Drug: OBE2109

Drug: Add-back