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
DRUGAdd-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
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
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
United States
Outcome results
None listed