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The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD1901 10 mg | Experimental | Oral once a day for 28 days |
|
| RAD1901 25 mg | Experimental | Oral once a day for 28 days |
|
| RAD1901 50 mg | Experimental | Oral once a day for 28 days |
|
| RAD1901 100 mg | Experimental | Oral once a day for 28 days |
|
| Placebo | Placebo Comparator | Oral once a day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD1901 | Drug | 10 mg Oral once a day for 28 days. |
| |
| RAD1901 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Frequency of Hot Flashes Over Time | Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population. | Week 4 minus baseline week |
| Percent Change in Composite Score Over Time | Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population. | Week 4 minus baseline week |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population. | Day 29 minus baseline |
| Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Radius Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radius Health, Inc. | Cambridge | Massachusetts | 02139 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27575546 | Derived | Hattersley G, Harris AG, Simon JA, Constantine GD. Clinical investigation of RAD1901, a novel estrogen receptor ligand, for the treatment of postmenopausal vasomotor symptoms: a phase 2 randomized, placebo-controlled, double-blind, dose-ranging, proof-of-concept trial. Menopause. 2017 Jan;24(1):92-99. doi: 10.1097/GME.0000000000000726. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RAD1901 10 mg | Oral once a day for 28 days |
| FG001 | RAD1901 25 mg | Oral once a day for 28 days |
| FG002 | RAD1901 50 mg | Oral once a day for 28 days |
| FG003 | RAD1901 100 mg | Oral once a day for 28 days |
| FG004 | Placebo | Oral once a day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RAD1901 10 mg | Oral once a day for 28 days |
| BG001 | RAD1901 25 mg | Oral once a day for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Frequency of Hot Flashes Over Time | Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population. | The intent-to-treat population is defined as all patients who received one or more doses of study drug. | Posted | Mean | Standard Deviation | Percent change from baseline | Week 4 minus baseline week |
|
Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.
Method of routinely determining whether or not certain adverse events have occurred was by regular investigator assessment and regular laboratory testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RAD1901 10 mg | Oral once a day for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Director | Radius Health, Inc. | (617) 551-4700 | info@radiuspharm.com |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626184 | RAD1901 |
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| Drug |
25 mg Oral once a day for 28 days |
|
| RAD1901 | Drug | 50 mg Oral once a day for 28 days. |
|
| RAD1901 | Drug | 100 mg Oral once a day for 28 days |
|
| Placebo | Drug | Placebo Oral once a day for 28 days |
|
Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population. |
| Day 29 minus baseline |
| Inability to complete study procedures |
|
| Lost to Follow-up |
|
| Personal reason |
|
| Prohibited medication |
|
| Sponsor decision |
|
| Withdrawal by Subject |
|
| BG002 |
| RAD1901 50 mg |
Oral once a day for 28 days |
| BG003 | RAD1901 100 mg | Oral once a day for 28 days |
| BG004 | Placebo | Oral once a day for 28 days |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| RAD1901 50 mg |
Oral once a day for 28 days |
| OG003 | RAD1901 100 mg | Oral once a day for 28 days |
| OG004 | Placebo | Oral once a day for 28 days |
|
|
| Secondary | Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population. | The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29. | Posted | Mean | Standard Deviation | Percent change from baseline | Day 29 minus baseline |
|
|
|
| Secondary | Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population. | The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29. | Posted | Mean | Standard Deviation | Percent change from baseline | Day 29 minus baseline |
|
|
|
| Primary | Percent Change in Composite Score Over Time | Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population. | The intent-to-treat population is defined as all patients who received one or more doses of study drug. | Posted | Mean | Standard Deviation | Percent change from baseline | Week 4 minus baseline week |
|
|
|
| 0 |
| 22 |
| 16 |
| 22 |
| EG001 | RAD1901 25 mg | Oral once a day for 28 days | 0 | 20 | 14 | 20 |
| EG002 | RAD1901 50 mg | Oral once a day for 28 days | 0 | 21 | 14 | 21 |
| EG003 | RAD1901 100 mg | Oral once a day for 28 days | 0 | 18 | 14 | 18 |
| EG004 | Placebo | Oral once a day for 28 days | 0 | 19 | 11 | 19 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Salivary Gland Enlargement | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Blood Triglyerides Increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Hypocholesterolaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscle Contracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sensation of Heaviness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cluster Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Trigeminal Neuralgia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Varicose Vein | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Results may not be published prior to Study Report completion. Subsequent to formation of a Publications Committee, Investigators may publish results, providing a manuscript to Sponsor =/> 30 days prior to its submission. Sponsor will provide manuscript to Investigators =/> 30 days prior to its submission. Investigator will comply with Sponsor's policy, withholding publication for another 60 days to permit Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.