Trial Outcomes & Findings for Raloxifene and Rimostil for Perimenopause-Related Depression (NCT NCT00030147)
NCT ID: NCT00030147
Last Updated: 2016-09-05
Results Overview
Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.
COMPLETED
PHASE4
65 participants
Baseline
2016-09-05
Participant Flow
Two participants signed the consent but were not started (did not meet inclusion criteria.)
Participant milestones
| Measure |
Estradiol
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
|
Placebo
Placebo skin patch and placebo tablets for eight weeks
|
Raloxifene
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
|
Rimostil
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
16
|
11
|
|
Overall Study
COMPLETED
|
17
|
18
|
16
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Raloxifene and Rimostil for Perimenopause-Related Depression
Baseline characteristics by cohort
| Measure |
Estradiol
n=17 Participants
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
|
Placebo
n=19 Participants
Placebo skin patch and placebo tablets for eight weeks
|
Raloxifene
n=16 Participants
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
|
Rimostil
n=11 Participants
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
63 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analyses included those subjects who started the study.
Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.
Outcome measures
| Measure |
Estradiol
n=17 Participants
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
|
Placebo
n=19 Participants
Placebo skin patch and placebo tablets for eight weeks
|
Raloxifene
n=16 Participants
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
|
Rimostil
n=11 Participants
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
|
|---|---|---|---|---|
|
Center for Epidemiologic Studies-Depression Scale (CES-D)
|
27.4 Units on a scale
Standard Deviation 5.76
|
29.1 Units on a scale
Standard Deviation 9
|
28.8 Units on a scale
Standard Deviation 7.9
|
24.6 Units on a scale
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: Week 8Population: The analyses included those subjects who completed eight weeks of study
Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.
Outcome measures
| Measure |
Estradiol
n=16 Participants
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
|
Placebo
n=17 Participants
Placebo skin patch and placebo tablets for eight weeks
|
Raloxifene
n=16 Participants
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
|
Rimostil
n=11 Participants
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
|
|---|---|---|---|---|
|
Center for Epidemiologic Studies-Depression Scale (CES-D)
|
9.6 Units on a scale
Standard Deviation 9.4
|
10.5 Units on a scale
Standard Deviation 11.3
|
15.8 Units on a scale
Standard Deviation 8.9
|
16.1 Units on a scale
Standard Deviation 8.8
|
Adverse Events
Estradiol
Placebo
Raloxifene
Rimostil
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Estradiol
n=17 participants at risk
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
|
Placebo
n=19 participants at risk
Placebo skin patch and placebo tablets for eight weeks
|
Raloxifene
n=16 participants at risk
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
|
Rimostil
n=11 participants at risk
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
|
|---|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/17
|
5.3%
1/19
|
0.00%
0/16
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/17
|
0.00%
0/19
|
6.2%
1/16
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17
|
0.00%
0/19
|
6.2%
1/16
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/17
|
5.3%
1/19
|
0.00%
0/16
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17
|
0.00%
0/19
|
0.00%
0/16
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place