Nocturnal Vasomotor Symptoms
Conditions
Keywords
Nocturnal vasomotor symptoms in postmenopausal women
Brief summary
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.
Interventions
DRUGSCE-B
0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
DRUGPlacebo
Matching placebo for 0.3 mg and 0.625 mg tablets
Sponsors
Duramed Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Naturally or surgically menopausal * Minimum 7 daily or 50 weekly moderate-to-severe hot flashes
Exclusion criteria
* Any contraindication to hormone therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes | Baseline to End of Treatment (Week 12) | Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Individual Sleep Parameters on a Three-point Scale | Baseline to End of Treatment (Week 12) | Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality) |
| Mean Change in Stanford Sleepiness Scale | Baseline to End of Treatment (Week 12) | Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest). |
| Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). | From baseline to End of Treatment (Week 12) | Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort. |
| Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) | Baseline to End of Treatment (Week 12) | Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort. |
| Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin). | Baseline to End of Treatment (12 weeks) | Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.3 mg SCE-B Daily SCE-B tablet 0.3 mg/day orally | 53 |
| 0.625 mg SCE-B Daily SCE-B tablet 0.625 mg/day orally | 52 |
| Placebo Daily Placebo tablet daily orally | 52 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Total | 0.3 mg SCE-B Daily | 0.625 mg SCE-B Daily | Placebo Daily |
|---|---|---|---|---|
| Age Continuous | 54.1 years STANDARD_DEVIATION 5.87 | 53.9 years STANDARD_DEVIATION 6 | 54.6 years STANDARD_DEVIATION 5.38 | 53.8 years STANDARD_DEVIATION 6.27 |
| Age, Customized Between 30 and 65 years | 157 participants | 53 participants | 52 participants | 52 participants |
| Region of Enrollment United States | 157 participants | 53 participants | 52 participants | 52 participants |
| Sex: Female, Male Female | 157 Participants | 53 Participants | 52 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 4 / 52 | 1 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 | 1 / 52 |
Outcome results
Primary
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Time frame: Baseline to End of Treatment (Week 12)
Population: Participants analyzed consisted of subjects from the intent-to-treat (ITT) cohort, \[all subjects who were exposed to investigational product therapy,provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit\]. Not all study subjects completed all data elements in their study diaries.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg SCE-B Daily | Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes | -19.54 Awakenings | Standard Error 1.195 |
| 0.625 mg SCE-B Daily | Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes | -20.55 Awakenings | Standard Error 1.286 |
| Placebo Daily | Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes | -15.99 Awakenings | Standard Error 1.234 |
Secondary
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Time frame: From baseline to End of Treatment (Week 12)
Population: Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg SCE-B Daily | Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). | -1.1 nM BCE | Standard Deviation 6.67 |
| 0.625 mg SCE-B Daily | Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). | -3.8 nM BCE | Standard Deviation 5.37 |
| Placebo Daily | Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). | -0.6 nM BCE | Standard Deviation 7.53 |
Secondary
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Time frame: Baseline to End of Treatment (Week 12)
Population: Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg SCE-B Daily | Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) | -3.7 ng*ml | Standard Deviation 7.29 |
| 0.625 mg SCE-B Daily | Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) | -4.4 ng*ml | Standard Deviation 7.94 |
| Placebo Daily | Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) | -0.3 ng*ml | Standard Deviation 6.47 |
Secondary
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Time frame: Baseline to End of Treatment (12 weeks)
Population: Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 0.3 mg SCE-B Daily | Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin). | 19.5 nmol/L | Standard Deviation 21.05 |
| 0.625 mg SCE-B Daily | Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin). | 44.8 nmol/L | Standard Deviation 38.86 |
| Placebo Daily | Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin). | -3.3 nmol/L | Standard Deviation 13.68 |
Secondary
Mean Change in Individual Sleep Parameters on a Three-point Scale
Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)
Time frame: Baseline to End of Treatment (Week 12)
Population: Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg SCE-B Daily | Mean Change in Individual Sleep Parameters on a Three-point Scale | 0.54 scores on a scale | Standard Error 0.066 |
| 0.625 mg SCE-B Daily | Mean Change in Individual Sleep Parameters on a Three-point Scale | 0.56 scores on a scale | Standard Error 0.068 |
| Placebo Daily | Mean Change in Individual Sleep Parameters on a Three-point Scale | 0.47 scores on a scale | Standard Error 0.067 |
Secondary
Mean Change in Stanford Sleepiness Scale
Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).
Time frame: Baseline to End of Treatment (Week 12)
Population: Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg SCE-B Daily | Mean Change in Stanford Sleepiness Scale | -0.79 Score on Scale | Standard Error 0.117 |
| 0.625 mg SCE-B Daily | Mean Change in Stanford Sleepiness Scale | -0.44 Score on Scale | Standard Error 0.117 |
| Placebo Daily | Mean Change in Stanford Sleepiness Scale | -0.62 Score on Scale | Standard Error 0.123 |