Hot Flashes
Conditions
Keywords
hot flashes, hot flushes, vasomotor symptoms, postmenopausal
Brief summary
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
Interventions
DRUGRAD1901
10 mg Oral once a day for 28 days.
DRUGPlacebo
Placebo Oral once a day for 28 days
Sponsors
Radius Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week. 2. Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities. 3. Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound. 4. Have a normal mammogram at the time of study screening.
Exclusion criteria
1. A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders. 2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease. 3. Unexplained vaginal bleeding within the 3 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Frequency of Hot Flashes Over Time | Week 4 minus baseline week | 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. |
| Percent Change in Composite Score Over Time | Week 4 minus baseline week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | Day 29 minus baseline | Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population. |
| Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | Day 29 minus baseline | Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RAD1901 10 mg Oral once a day for 28 days | 22 |
| RAD1901 25 mg Oral once a day for 28 days | 20 |
| RAD1901 50 mg Oral once a day for 28 days | 21 |
| RAD1901 100 mg Oral once a day for 28 days | 18 |
| Placebo Oral once a day for 28 days | 19 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Inability to complete study procedures | 1 | 0 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Personal reason | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Prohibited medication | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Sponsor decision | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | RAD1901 10 mg | Total | Placebo | RAD1901 100 mg | RAD1901 50 mg | RAD1901 25 mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 5.74 | 54.3 years STANDARD_DEVIATION 6.24 | 53.8 years STANDARD_DEVIATION 5.74 | 55.7 years STANDARD_DEVIATION 6.45 | 53.7 years STANDARD_DEVIATION 5.68 | 55.2 years STANDARD_DEVIATION 7.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 100 Participants | 19 Participants | 18 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Female | 22 Participants | 100 Participants | 19 Participants | 18 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 22 | 14 / 20 | 14 / 21 | 14 / 18 | 11 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 | 0 / 21 | 0 / 18 | 0 / 19 |
Outcome results
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.
Time frame: Week 4 minus baseline week
Population: The intent-to-treat population is defined as all patients who received one or more doses of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAD1901 10 mg | Percent Change in Composite Score Over Time | -75.65 Percent change from baseline | Standard Deviation 18.655 |
| RAD1901 25 mg | Percent Change in Composite Score Over Time | -55.48 Percent change from baseline | Standard Deviation 39.442 |
| RAD1901 50 mg | Percent Change in Composite Score Over Time | -48.78 Percent change from baseline | Standard Deviation 39.806 |
| RAD1901 100 mg | Percent Change in Composite Score Over Time | -66.21 Percent change from baseline | Standard Deviation 33.226 |
| Placebo | Percent Change in Composite Score Over Time | -55.80 Percent change from baseline | Standard Deviation 35.523 |
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.
Time frame: Week 4 minus baseline week
Population: The intent-to-treat population is defined as all patients who received one or more doses of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAD1901 10 mg | Percent Change in Frequency of Hot Flashes Over Time | -77.2 Percent change from baseline | Standard Deviation 20.43 |
| RAD1901 25 mg | Percent Change in Frequency of Hot Flashes Over Time | -51.8 Percent change from baseline | Standard Deviation 45.02 |
| RAD1901 50 mg | Percent Change in Frequency of Hot Flashes Over Time | -53.8 Percent change from baseline | Standard Deviation 39.16 |
| RAD1901 100 mg | Percent Change in Frequency of Hot Flashes Over Time | -67.0 Percent change from baseline | Standard Deviation 33.85 |
| Placebo | Percent Change in Frequency of Hot Flashes Over Time | -54.1 Percent change from baseline | Standard Deviation 37.72 |
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.
Time frame: Day 29 minus baseline
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAD1901 10 mg | Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | 4.24 Percent change from baseline | Standard Deviation 34.077 |
| RAD1901 25 mg | Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | -6.56 Percent change from baseline | Standard Deviation 13.933 |
| RAD1901 50 mg | Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | -4.42 Percent change from baseline | Standard Deviation 24.381 |
| RAD1901 100 mg | Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | -3.26 Percent change from baseline | Standard Deviation 11.373 |
| Placebo | Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time. | 8.67 Percent change from baseline | Standard Deviation 62.175 |
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.
Time frame: Day 29 minus baseline
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAD1901 10 mg | Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | -12.81 Percent change from baseline | Standard Deviation 27.551 |
| RAD1901 25 mg | Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | -0.19 Percent change from baseline | Standard Deviation 19.573 |
| RAD1901 50 mg | Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | -10.94 Percent change from baseline | Standard Deviation 22.609 |
| RAD1901 100 mg | Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | 3.57 Percent change from baseline | Standard Deviation 22.392 |
| Placebo | Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time. | 6.70 Percent change from baseline | Standard Deviation 36.27 |