Uterine Fibroids, Heavy Menstrual Bleeding
Conditions
Brief summary
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 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 BG2109 alone and in combination with add-back therapy (Estradiol 1 mg / Norethindrone Acetate 0.5 mg) for the treatment of uterine fibroids in China.
Interventions
DRUGBG2109
BG2109 100mg film coated tablet for oral administration once daily.
DRUGPlacebo for BG2109
Placebo for BG2109 100mg tablet for oral administration once daily.
DRUGPlacebo for add-back therapy
Placebo for add-back therapy tablet for oral administration once daily.
DRUGAdd-back therapy
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Sponsors
Bio Genuine (Shanghai) Biotech Co., Ltd.
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: 1. Subject is an 18 years and older premenopausal woman. 2. Subject's Body Mass Index ≥ 18 kg/m2. 3. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound. 4. Subject's menstrual cycles is between 21 days and 35 days in the last 3 months. 5. Subject has clinical manifestations of heavy menstrual bleeding. 6. Subject's menstrual blood loss \>80mL for at least 2 menstrual periods assessed at screening using the alkaline hematin method. Key
Exclusion criteria
1. The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study. 2. The subject has a history of uterus surgery that would interfere with the study. 3. The subject's condition is so severe that she will require surgery within 6 months. 4. The subject have had or are currently suffering from any estrogen- dependent malignancy. 5. The subject has a significant risk of osteoporosis, or have a known history of 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. | The last 28 days before the Week 24. | MBL will be determined using the Alkaline Hematin method (AHM). Responder means whose MBL less than 80mL during the last 28 days before the Week 24 and more than 50% reduction in MBL compared to the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reduced MBL before the Week 24. | From baseline to Week 24. | Reduced MBL means MBL less than 80ml and more than 50% reduction in MBL compared to the baseline. |
| Percentage of amenorrhea at the Week 24. | From baseline to Week 24. | Amenorrhea is defined as having 0 data (or volume below the lower limit of quantification) from the AHM of MBL from the central laboratory or missing of AHM data with reported of spotting or no bleeding in the eDiary for 35 days before Week 24. |
| Time to amenorrhea before the Week 24. | From baseline to Week 24. | The number of days from Study Day 1 to the first day having amenorrhea. |
| Days of menstrual bleeding in the last 28 days before the Week 24. | The last 28 days before the Week 24. | Record the number of days. |
| Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia. | The Week 24. | Anemia is defined as hemoglobin below 12g/dL at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density (BMD) | The Week 24 and Week 52. | Assessed by dual-energy X-ray absorptiometry (DXA) scan. |
| Percentage of Responders at the Week 52. | The last 28 days before the Week 52. | Responder is defined as above. |
| Adverse events | Up to Week 64. | Clinical manifestation，frequency and severity of Treatment-Emergent Adverse Events. |
| Time to reduced MBL before the Week 52. | From baseline to Week 52. | Reduced MBL is defined as above. |
| Percentage of amenorrhea at the Week 52. | From baseline to Week 52. | Amenorrhea is defined as above. |
| Time to amenorrhea before the Week 52. | From baseline to Week 52. | The number of days from Study Day 1 to the first day having amenorrhea. |
| By 52 weeks, the number of days with menstrual bleeding per 28 days. | From baseline to Week 52. | Record the number every 28days. |
| Score of Uterine Fibroids related pain, symptoms and quality of life. | From Week 12 to Week 64 | Use specified scales. |
Countries
China
Contacts
Primary ContactLisa Chen
Outcome results
None listed