A phase 3 study of OBE2109 in subjects with heavy menstrual bleeding associated with uterine fibroids.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004059-53-HU

Enrollment

500

Registered

2017-04-04

Start date

2017-05-25

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of heavy menstrual bleeding associated with uterine fibroids. MedDRA version: 20.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000021126

Interventions

Product Name: OBE2109 Product Code: OBE2109 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: NA Current Sponsor code: OBE2109 Other descriptive name: OBE2109 Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy objective: 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. Safety objectives: - To assess the effect of OBE2109 alone and in combination with add-back therapy versus placebo on bone mineral density. - To assess the overall safety of OBE2109 alone and in combination with add-back therapy in subjects with uterine fibroids.;Secondary Objective: Efficacy: To demonstrate the superior efficacy of 24 weeks of OBE2109 alone and in combination with add-back therapy versus placebo on: - Incidence of amenorrhea and time to amenorrhea - Hemoglobin levels - Menstrual bleeding To evaluate the effect of 24 weeks of OBE2109 alone and in combination with add-back therapy versus placebo on: - Pain - Uterine fibroid symptom severity and health-related quality of life - Uterus volume - Myoma volume To evaluate the effect of 52 weeks of OBE2109 alone and in combination with add-back therapy on the above-listed assessments.;Primary end point(s): Reduced menstrual blood loss at 24 weeks of treatment (last 28 days prior to Week 24 visit) defined as menstrual blood loss = 80 mL and = 50% reduction from baseline.;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: Efficacy objective: 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. Safety objectives: - To assess the effect of OBE2109 alone and in combination with add-back therapy versus placebo on bone mineral density. - To assess the overall safety of OBE2109 alone and in combination with add-back therapy in subjects with uterine fibroids.;Secondary Objective: Efficacy: To demonstrate the superior efficacy of 24 weeks of OBE2109 alone and in combination with add-back therapy versus placebo on: - Incidence of amenorrhea and time to amenorrhea - Hemoglobin levels - Menstrual bleeding To evaluate the effect of 24 weeks of OBE2109 alone and in combination with add-back therapy versus placebo on: - Pain - Uterine fibroid symptom severity and health-related quality of life - Uterus volume - Myoma volume To evaluate the effect of 52 weeks of OBE2109 alone and in combination with add-back therapy on the above-listed assessments.;Primary end point(s): Reduced menstrual blood loss at 24 weeks of treatment (last 28 days prior to Week 24 visit) defined as menstrual blood loss = 80 mL and = 50% reduction from baseline.;Timepoint(s) of evaluation of this end point: Week 24

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Secondary

Measure	Time frame
Secondary end point(s): 1. Amenorrhea assessed using the alkaline hematin method 2. Time to amenorrhea 3. Time to reduced menstrual blood loss assessed using the alkaline hematin method 4. Number of days of uterine bleeding for each 28-day interval assessed using the alkaline hematin method 5. Hemoglobin levels (Laboratory assessment) 6. Bone Mineral Density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) scan 7. Endometrial biopsy assessed by histology 8. Endometrial thickness (assessed by ultrasound) 9. Adverse events -Frequency and severity of Treatment-Emergent Adverse Events 10. Clinical laboratory assessments and vital signs -clinically significant changes from baseline in clinical laboratory assessments and vital signs ;Timepoint(s) of evaluation of this end point: 1. Up to Weeks 24 and 52 2. Up to Weeks 24 and 52 3. Up to Weeks 24 and 52 4. Up to Week 52 5. Weeks 12, 24, 36, 52, 64 6. Weeks 24, 52, 76 7. Weeks 24, 52 8. Up to Week 64 9. Up to Week 76 10. From baseline up to Week 64	—

Measure

Time frame

Secondary end point(s): 1. Amenorrhea assessed using the alkaline hematin method 2. Time to amenorrhea 3. Time to reduced menstrual blood loss assessed using the alkaline hematin method 4. Number of days of uterine bleeding for each 28-day interval assessed using the alkaline hematin method 5. Hemoglobin levels (Laboratory assessment) 6. Bone Mineral Density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) scan 7. Endometrial biopsy assessed by histology 8. Endometrial thickness (assessed by ultrasound) 9. Adverse events -Frequency and severity of Treatment-Emergent Adverse Events 10. Clinical laboratory assessments and vital signs -clinically significant changes from baseline in clinical laboratory assessments and vital signs ;Timepoint(s) of evaluation of this end point: 1. Up to Weeks 24 and 52 2. Up to Weeks 24 and 52 3. Up to Weeks 24 and 52 4. Up to Week 52 5. Weeks 12, 24, 36, 52, 64 6. Weeks 24, 52, 76 7. Weeks 24, 52 8. Up to Week 64 9. Up to Week 76 10. From baseline up to Week 64

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Countries

Bulgaria, Czech Republic, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Ukraine, United States

Contacts

Public ContactClinical Trial Information

ObsEva SA

clinicaltrials@obseva.ch+41225523840

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026