Heavy Menstrual Bleeding, Uterine Fibroids
Conditions
Keywords
Uterine Fibroid, Leiomyomata, Heavy Menstrual Bleeding, HMB, Heavy Uterine Bleeding, Menorrhagia, OBE2109 + Add-back
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.
Interventions
DRUGOBE2109
OBE2109 100mg tablets for oral administration once daily
Placebo to match OBE2109 100mg tablets for oral administration once daily
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
DRUGAdd-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Sponsors
ObsEva SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Amenorrhea | Up to Week 52 | Assessed using the alkaline hematin method |
| Time to amenorrhea | Up to Week 52 | — |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to Week 76 | Frequency and severity of Treatment-Emergent Adverse Events |
| Endometrial biopsy | From baseline up to Week 52 | Assessed by histology |
| Bone Mineral Density (BMD) | From baseline up to Week 76 | Assessed by dual-energy X-ray absorptiometry (DXA) scan |
Countries
Bulgaria, Czechia, Hungary, Latvia, Lithuania, Poland, Romania, Ukraine, United States
Outcome results
None listed