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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 0.3 mg SCE-B Daily |
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| 2 | Experimental | 0.625 mg SCE-B Daily |
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| 3 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCE-B | Drug | 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to End of Treatment (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to End of Treatment (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Anaheim | California | 92801 | United States | ||
| Duramed Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22183214 | Derived | Liu JH, Reape KZ, Hait HI. Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):78-84. doi: 10.1097/AOG.0b013e31823c0145. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3 mg SCE-B Daily | SCE-B tablet 0.3 mg/day orally |
| FG001 | 0.625 mg SCE-B Daily | SCE-B tablet 0.625 mg/day orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching placebo for 0.3 mg and 0.625 mg tablets |
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| 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). | Baseline to End of Treatment (Week 12) |
| 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. | From baseline to End of Treatment (Week 12) |
| 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. | Baseline to End of Treatment (Week 12) |
| 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. | Baseline to End of Treatment (12 weeks) |
| Sacramento |
| California |
| 95821 |
| United States |
| Duramed Investigational Site | San Diego | California | 92108 | United States |
| Duramed Investigational Site | Clearwater | Florida | 33759 | United States |
| Duramed Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Duramed Investigational Site | Lexington | Kentucky | 40509 | United States |
| Duramed Investigational Site | Louisville | Kentucky | 40291 | United States |
| Duramed Investigational Site | Lincoln | Nebraska | 68510 | United States |
| Duramed Investigational Site | Moorestown | New Jersey | 08057 | United States |
| Duramed Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Duramed Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Duramed Investigational Site | Cleveland | Ohio | 44122 | United States |
| Duramed Investigational Site | Mayfield Heights | Ohio | 44124 | United States |
| Duramed Investigational Site | Medford | Oregon | 97504 | United States |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Duramed Investigational Site | Columbia | South Carolina | 29201 | United States |
| Duramed Investigational Site | San Antonio | Texas | 78229 | United States |
| FG002 |
| Placebo Daily |
Placebo tablet daily orally |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3 mg SCE-B Daily | SCE-B tablet 0.3 mg/day orally |
| BG001 | 0.625 mg SCE-B Daily | SCE-B tablet 0.625 mg/day orally |
| BG002 | Placebo Daily | Placebo tablet daily orally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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 | 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. | Posted | Least Squares Mean | Standard Error | Awakenings | Baseline to End of Treatment (Week 12) |
|
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| |||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline to End of Treatment (Week 12) |
| |||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Least Squares Mean | Standard Error | Score on Scale | Baseline to End of Treatment (Week 12) |
|
| ||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | nM BCE | From baseline to End of Treatment (Week 12) |
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| 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. | 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. | Posted | Mean | Standard Deviation | ng*ml | Baseline to End of Treatment (Week 12) |
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| 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. | 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. | Posted | Median | Standard Deviation | nmol/L | Baseline to End of Treatment (12 weeks) |
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Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks).
Adverse events were reported during the subject's regularly scheduled visits at the investigational site.
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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 | 0.3 mg SCE-B Daily | SCE-B tablet 0.3 mg/day orally | 0 | 53 | 0 | 53 | ||
| EG001 | 0.625 mg SCE-B Daily | SCE-B tablet 0.625 mg/day orally | 0 | 52 | 4 | 52 | ||
| EG002 | Placebo Daily | Placebo tablet daily orally | 1 | 52 | 1 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right tibia and fibula shaft fracture | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Naspoharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duramed Research Protocol Chair | Duramed Research | 215-293-7279 | medicalaffairs@barrlabs.com |
| ID | Term |
|---|---|
| C509657 | estrogens, conjugated synthetic B |
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