Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Phase 3

Completed

• Conditions: Uterine Fibroids; Heavy Menstrual Bleeding
• Interventions: Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Add-back; Drug: Placebo to match Add-back

• Registration Number: NCT03070899
• Lead Sponsor: ObsEva SA

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-06
• Study Start: 2017-04-20
• Primary Completion: 2020-04-14
• Study Completion: 2021-04-12
• Disposition First Submitted: 2021-05-20
• Status Verified: 2021-06
• Disposition First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Disposition First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 526

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back	OBE2109	-
OBE2109 dose 1 (100mg) + Add-back	OBE2109	-
OBE2109 dose 1 (100mg) + Add-back	Placebo to match OBE2109	-
OBE2109 dose 1 (100mg) + Placebo Add-back	OBE2109	-
OBE2109 dose 1 (100mg) + Placebo Add-back	Placebo to match OBE2109	-
OBE2109 dose 1 (100mg) + Add-back	Add-back	-
OBE2109 dose 2 (200mg) + Add-back	OBE2109	-
OBE2109 dose 1 (100mg) + Placebo Add-back	Placebo to match Add-back	-
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back	Placebo to match Add-back	At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back	Placebo to match Add-back	-
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back	Add-back	-
OBE2109 dose 2 (200mg) + Add-back	Add-back	-
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back	OBE2109	At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back	Add-back	At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back	Placebo to match OBE2109	At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.

Primary Outcome Measures

Name	Time	Method
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24	From baseline to Week 24	Assessed using the alkaline hematin method

Secondary Outcome Measures

Name	Time	Method
Amenorrhea	Up to Week 52	Assessed using the alkaline hematin method
Number of days of uterine bleeding for the last 28-day interval prior to Week 24	last 28-day interval prior to Week 24	Assessed using the alkaline hematin method
Number of days of uterine bleeding for each 28-day interval	Up to Week 52	Assessed using the alkaline hematin method
Time to reduced menstrual blood loss	Up to Week 52	Assessed using the alkaline hematin method
Time to amenorrhea	Up to Week 52

Trial Locations

Locations (116)

Site reference ID 192; 🇺🇸 Birmingham, Alabama, United States

Site reference ID 169; 🇺🇸 Dothan, Alabama, United States

Site reference ID 353; 🇺🇸 Mobile, Alabama, United States

Site reference ID 232; 🇺🇸 Vestavia Hills, Alabama, United States

Site reference ID 242; 🇺🇸 Phoenix, Arizona, United States

Site reference ID 355; 🇺🇸 Tucson, Arizona, United States

Site reference ID 211; 🇺🇸 Arcadia, California, United States

Site reference ID 184; 🇺🇸 Cerritos, California, United States

Site reference ID 147; 🇺🇸 Escondido, California, United States

Site reference ID 154; 🇺🇸 Huntington Park, California, United States

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