Trial Outcomes & Findings for Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women (NCT NCT00592839)
NCT ID: NCT00592839
Last Updated: 2013-07-19
Results Overview
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
COMPLETED
PHASE4
157 participants
Baseline to End of Treatment (Week 12)
2013-07-19
Participant Flow
Participant milestones
| Measure |
0.3 mg SCE-B Daily
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
Placebo tablet daily orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
52
|
|
Overall Study
COMPLETED
|
51
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
6
|
Reasons for withdrawal
| Measure |
0.3 mg SCE-B Daily
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
Placebo tablet daily orally
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
0.3 mg SCE-B Daily
n=53 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=52 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=52 Participants
Placebo tablet daily orally
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Between 30 and 65 years
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
52 participants
n=5 Participants
|
157 participants
n=4 Participants
|
|
Age Continuous
|
53.9 years
STANDARD_DEVIATION 6.00 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 5.38 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 6.27 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 5.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
52 participants
n=5 Participants
|
157 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Outcome measures
| Measure |
0.3 mg SCE-B Daily
n=52 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=48 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=51 Participants
Placebo tablet daily orally
|
|---|---|---|---|
|
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
|
-19.54 Awakenings
Standard Error 1.195
|
-20.55 Awakenings
Standard Error 1.286
|
-15.99 Awakenings
Standard Error 1.234
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
0.3 mg SCE-B Daily
n=52 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=49 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=51 Participants
Placebo tablet daily orally
|
|---|---|---|---|
|
Mean Change in Individual Sleep Parameters on a Three-point Scale
|
0.54 scores on a scale
Standard Error 0.066
|
0.56 scores on a scale
Standard Error 0.068
|
0.47 scores on a scale
Standard Error 0.067
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
0.3 mg SCE-B Daily
n=47 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=49 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=48 Participants
Placebo tablet daily orally
|
|---|---|---|---|
|
Mean Change in Stanford Sleepiness Scale
|
-0.79 Score on Scale
Standard Error 0.117
|
-0.44 Score on Scale
Standard Error 0.117
|
-0.62 Score on Scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: 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.
Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Outcome measures
| Measure |
0.3 mg SCE-B Daily
n=45 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=41 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=42 Participants
Placebo tablet daily orally
|
|---|---|---|---|
|
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
|
-1.1 nM BCE
Standard Deviation 6.67
|
-3.8 nM BCE
Standard Deviation 5.37
|
-0.6 nM BCE
Standard Deviation 7.53
|
SECONDARY outcome
Timeframe: 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.
Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Outcome measures
| Measure |
0.3 mg SCE-B Daily
n=45 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=40 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=42 Participants
Placebo tablet daily orally
|
|---|---|---|---|
|
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
|
-3.7 ng*ml
Standard Deviation 7.29
|
-4.4 ng*ml
Standard Deviation 7.94
|
-0.3 ng*ml
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
0.3 mg SCE-B Daily
n=45 Participants
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=41 Participants
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=42 Participants
Placebo tablet daily orally
|
|---|---|---|---|
|
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
|
19.5 nmol/L
Standard Deviation 21.05
|
44.8 nmol/L
Standard Deviation 38.86
|
-3.3 nmol/L
Standard Deviation 13.68
|
Adverse Events
0.3 mg SCE-B Daily
0.625 mg SCE-B Daily
Placebo Daily
Serious adverse events
| Measure |
0.3 mg SCE-B Daily
n=53 participants at risk
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=52 participants at risk
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=52 participants at risk
Placebo tablet daily orally
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Right tibia and fibula shaft fracture
|
0.00%
0/53 • 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.
|
0.00%
0/52 • 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.
|
1.9%
1/52 • Number of events 1 • 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.
|
Other adverse events
| Measure |
0.3 mg SCE-B Daily
n=53 participants at risk
SCE-B tablet 0.3 mg/day orally
|
0.625 mg SCE-B Daily
n=52 participants at risk
SCE-B tablet 0.625 mg/day orally
|
Placebo Daily
n=52 participants at risk
Placebo tablet daily orally
|
|---|---|---|---|
|
Infections and infestations
Naspoharyngitis
|
0.00%
0/53 • 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.
|
3.8%
2/52 • Number of events 2 • 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.
|
1.9%
1/52 • Number of events 1 • 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • 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.
|
3.8%
2/52 • Number of events 2 • 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.
|
0.00%
0/52 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER