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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
Phase 3 trial testing Vilaprisan (BAY1002670) in Uterine Fibroids in 93 participants. Terminated before completion.
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 93 |
| Start date | 17 January 2018 |
| Primary completion | 9 June 2019 |
| Estimated completion | 6 April 2022 |
| Sites | 103 locations across New Zealand, South Africa, Malaysia, Israel, Bulgaria, China, Singapore, United States |
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18 and older, female only, with Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 16 | |
| Vilaprisan (A2) | 20 | |
| Placebo+Vilaprisan (B1) | 4 | |
| Vilaprisan+Placebo (B2) | 15 |
HMB response was defined as MBL \<80 mL during the last 28 days of treatment and \>50% reduction from baseline based on AH-method.
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 17 | |
| Vilaprisan (A2) | 20 | |
| Placebo+Vilaprisan (B1) | 8 | |
| Vilaprisan+Placebo (B2) | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 6 | |
| Vilaprisan (A2) | 14 | |
| Placebo+Vilaprisan (B1) | 6 | |
| Vilaprisan+Placebo (B2) | 1 |
Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \< 2 mL (amenorrhea defined similar to primary endpoint).
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 3 | 2 – 4 |
| Vilaprisan (A2) | NA | NA – NA |
| Placebo+Vilaprisan (B1) | NA | NA – NA |
| Vilaprisan+Placebo (B2) | 6 | 1 – 46 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 21 | 2 – 32 |
| Vilaprisan (A2) | NA | NA – NA |
| Placebo+Vilaprisan (B1) | 2 | 1 – NA |
| Vilaprisan+Placebo (B2) | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | NA | NA – NA |
| Vilaprisan (A2) | 9 | 3 – 107 |
| Placebo+Vilaprisan (B1) | NA | NA – NA |
| Vilaprisan+Placebo (B2) | NA | NA – NA |
Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<80.00 mL based on AH-method.
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 1 | 1 – 2 |
| Vilaprisan (A2) | NA | NA – NA |
| Placebo+Vilaprisan (B1) | NA | 53 – NA |
| Vilaprisan+Placebo (B2) | 1 | 1 – 1 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 1 | 1 – 1 |
| Vilaprisan (A2) | NA | NA – NA |
| Placebo+Vilaprisan (B1) | 1 | 1 – 2 |
| Vilaprisan+Placebo (B2) | NA | NA – NA |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | NA | NA – NA |
| Vilaprisan (A2) | 1 | 1 – 7 |
| Placebo+Vilaprisan (B1) | NA | NA – NA |
| Vilaprisan+Placebo (B2) | NA | NA – NA |
Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the Uterine Fibroid Daily Bleeding Diary (UF-DBD).
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 16 | |
| Vilaprisan (A2) | 20 | |
| Placebo+Vilaprisan (B1) | 4 | |
| Vilaprisan+Placebo (B2) | 15 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 6 | |
| Vilaprisan (A2) | 13 | |
| Placebo+Vilaprisan (B1) | 6 | |
| Vilaprisan+Placebo (B2) | 0 |
Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 17 | |
| Vilaprisan (A2) | 20 | |
| Placebo+Vilaprisan (B1) | 17 | |
| Vilaprisan+Placebo (B2) | 22 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 0 | |
| Vilaprisan (A2) | 0 | |
| Placebo+Vilaprisan (B1) | 0 | |
| Vilaprisan+Placebo (B2) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 1 | |
| Vilaprisan (A2) | 0 | |
| Placebo+Vilaprisan (B1) | 0 | |
| Vilaprisan+Placebo (B2) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 0 | |
| Vilaprisan (A2) | 0 | |
| Placebo+Vilaprisan (B1) | 0 | |
| Vilaprisan+Placebo (B2) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | 1 | |
| Vilaprisan (A2) | 1 | |
| Placebo+Vilaprisan (B1) | 1 | |
| Vilaprisan+Placebo (B2) | 0 |
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | -2.2 | ± 3.0 |
| Vilaprisan (A2) | -1.3 | ± 4.3 |
| Placebo+Vilaprisan (B1) | -1.8 | ± 4.9 |
| Vilaprisan+Placebo (B2) | -1.8 | ± 3.4 |
| Group | Value | 95% CI |
|---|---|---|
| Vilaprisan (A1) | -3.0 | ± 4.6 |
| Vilaprisan (A2) | -0.5 | ± 3.8 |
| Placebo+Vilaprisan (B1) | -3.1 | ± 4.0 |
| Vilaprisan+Placebo (B2) | -1.8 | ± 3.7 |
Time frame: For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Vilaprisan - Treatment Eme… | Placebo - Treatment Emerge… | Vilaprisan (A1) - Post Tre… | Vilaprisan (A2) - Post Tre… | Placebo+ Vilaprisan (B1) -… | Vilaprisan+ Placebo (B2) -… |
|---|---|---|---|---|---|---|---|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Hysterectomy | Surgical and medical procedures | — | — | — | — | — | — |
| Myomectomy | Surgical and medical procedures | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Iron deficiency anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — | — | — |
| Adrenal mass | Endocrine disorders | — | — | — | — | — | — |
| Chest pain | General disorders | — | — | — | — | — | — |
| Cystoscopy | Investigations | — | — | — | — | — | — |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Renal mass | Renal and urinary disorders | — | — | — | — | — | — |
| Dysmenorrhoea | Reproductive system and breast disorders | — | — | — | — | — | — |
| Endometrial hyperplasia | Reproductive system and breast disorders | — | — | — | — | — | — |
| Menometrorrhagia | Reproductive system and breast disorders | — | — | — | — | — | — |
| Uterine haemorrhage | Reproductive system and breast disorders | — | — | — | — | — | — |
| Abnormal uterine bleeding | Reproductive system and breast disorders | — | — | — | — | — | — |
| Renal lesion excision | Surgical and medical procedures | — | — | — | — | — | — |
| Salpingectomy | Surgical and medical procedures | — | — | — | — | — | — |
| Endometrial ablation | Surgical and medical procedures | — | — | — | — | — | — |
| Hysterosalpingectomy | Surgical and medical procedures | — | — | — | — | — | — |
| Deep vein thrombosis | Vascular disorders | — | — | — | — | — | — |
| Reaction | System | Vilaprisan - Treatment Eme… | Placebo - Treatment Emerge… | Vilaprisan (A1) - Post Tre… | Vilaprisan (A2) - Post Tre… | Placebo+ Vilaprisan (B1) -… | Vilaprisan+ Placebo (B2) -… |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Hot flush | Vascular disorders | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Abdominal pain lower | Gastrointestinal disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Endometrial thickening | Reproductive system and breast disorders | — | — | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — | — | — |
| Blood testosterone increased | Investigations | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Ovarian cyst | Reproductive system and breast disorders | — | — | — | — | — | — |
| Heavy menstrual bleeding | Reproductive system and breast disorders | — | — | — | — | — | — |
| Night sweats | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — | — | — |
| Cushing's syndrome | Endocrine disorders | — | — | — | — | — | — |
| Eye swelling | Eye disorders | — | — | — | — | — | — |
| Chest pain | General disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Onychomycosis | Infections and infestations | — | — | — | — | — | — |
| Pyoderma | Infections and infestations | — | — | — | — | — | — |
| Blood pressure increased | Investigations | — | — | — | — | — | — |
| Blood thyroid stimulating hormone increased | Investigations | — | — | — | — | — | — |
| Cortisol increased | Investigations | — | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — | — |
| Presyncope | Nervous system disorders | — | — | — | — | — | — |
| Poor quality sleep | Psychiatric disorders | — | — | — | — | — | — |
| Endometrial hyperplasia | Reproductive system and breast disorders | — | — | — | — | — | — |
| Uterine polyp | Reproductive system and breast disorders | — | — | — | — | — | — |
| Vaginal haemorrhage | Reproductive system and breast disorders | — | — | — | — | — | — |
| Fallopian tube cyst | Reproductive system and breast disorders | — | — | — | — | — | — |
Most-reported serious reactions: Uterine leiomyoma, Hysterectomy, Myomectomy, Anaemia, Iron deficiency anaemia, Palpitations, Adrenal mass, Chest pain.
Data from ClinicalTrials.gov NCT03400943 adverse events section.
The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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