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Perimenopausal Effects of Estradiol on Reward Responsiveness (PEERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255175
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Perimenopausal Depression
Interventions Drug: Estradiol
Drug: Progesterone
Enrollment 64
Recruitment Details The recruitment process included, social media advertising using Facebook, Instagram, and Craigslist; mass emailing using university wide emails and a database of select University of North Carolina (UNC) healthcare patients (Carolina data warehouse); and flyer advertisements placed in university buildings and local businesses.
Pre-assignment Details Enrolled participants were excluded prior to the start of study intervention due to: exclusionary psychiatric history (i.e. substance abuse, past hypomania, persistent depression), exclusionary gynecological history (i.e. fibroids, abnormal pap), exclusionary medical history (i.e. abnormal lab values), exclusionary medication, and imaging concerns.
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Period Title: Overall Study
Started 33 31
Completed 16 19
Not Completed 17 12
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed Total
Hide Arm/Group Description

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Total of all reporting groups
Overall Number of Baseline Participants 33 31 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 33 participants 31 participants 64 participants
50.13
(44 to 55)
50.76
(44 to 55)
50.44
(44 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 31 participants 64 participants
Female
33
 100.0%
31
 100.0%
64
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 33 participants 31 participants 64 participants
White or Caucasion
23
  69.7%
30
  96.8%
53
  82.8%
Black or African American
8
  24.2%
1
   3.2%
9
  14.1%
Multi-Racial
1
   3.0%
0
   0.0%
1
   1.6%
Cuban or Carribean
1
   3.0%
0
   0.0%
1
   1.6%
1.Primary Outcome
Title Caudate Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment
Hide Description Caudate reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment.
Time Frame Pre-treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
.027  (.105) .043  (.074)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .620
Comments [Not Specified]
Method t-test, 2 sided
Comments t=.501, df=33
2.Primary Outcome
Title Nucleus Accumbens (NAcc) Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment
Hide Description Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment.
Time Frame Pre-treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
.045  (.117) .052  (.108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .855
Comments [Not Specified]
Method t-test, 2 sided
Comments t=.185, df=33
3.Primary Outcome
Title Putamen Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment
Hide Description Putamen reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment.
Time Frame Pre-treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
.015  (.103) .004  (.093)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .758
Comments [Not Specified]
Method t-test, 2 sided
Comments t=-.310, df=33
4.Primary Outcome
Title Caudate Signal Intensity in Response to Reward During the MID fMRI Task Following Estradiol Treatment.
Hide Description Caudate reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment.
Time Frame Post-treatment (visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
.005  (.079) .026  (.103)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .518
Comments [Not Specified]
Method t-test, 2 sided
Comments t=.653, df=33
5.Primary Outcome
Title Nucleus Accumbens (NAcc) Signal Intensity in Response to Reward During the MID fMRI Task Following Estradiol Treatment.
Hide Description Nucleus accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment.
Time Frame Post-treatment (visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
.040  (.110) .059  (.118)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .645
Comments [Not Specified]
Method t-test, 2 sided
Comments t=.465, df=33
6.Primary Outcome
Title Putamen Signal Intensity in Response to Reward During the MID fMRI Task Following Estradiol Treatment.
Hide Description Putamen reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment.
Time Frame Post-treatment (visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
-.030  (.068) .032  (.073)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .015
Comments [Not Specified]
Method t-test, 2 sided
Comments t=2.56, df=33
7.Secondary Outcome
Title Response Latency to Reward During the MID fMRI Task at Pre-treatment
Hide Description Time (ms) between stimulus and response will be measured during the Monetary Incentive Delay (MID) task during the win trials. During MID the task, participants need to select the correct response during "win" and "lose" conditions by pressing a button on a button box in the MRI.
Time Frame Pre-treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: Milliseconds
204.17  (25.11) 209.63  (20.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .486
Comments [Not Specified]
Method t-test, 2 sided
Comments t=.705, df=33
8.Secondary Outcome
Title Response Latency to Reward During the MID fMRI Task Following Estradiol Treatment
Hide Description Time (ms) between stimulus and response will be measured during reward trials of the Monetary Incentive Delay (MID) task. During MID the task, participants need to select the correct response during "win" and "lose" conditions by pressing a button on a button box in the MRI.
Time Frame Post-treatment (visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: Milliseconds
190.68  (34.98) 193.43  (39.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Perimenopausal Women, Non-depressed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .831
Comments [Not Specified]
Method t-test, 2 sided
Comments t=.216, df=33
9.Secondary Outcome
Title Change in Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Scores
Hide Description The Dysphoria Scale of the Inventory of Depression and Anxiety Symptoms (IDAS) will be used to assess the change in depressive symptom severity. The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating "not at all" and 5 indicating "extremely". As such, the range of possible scores is 10 to 50. The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry. Higher scores indicate worse depression symptoms.
Time Frame Assessed at pre- and post-treatment (visits 3 and 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Perimenopausal Women, Depressed, Baseline Perimenopausal Women, Non-depressed, Baseline Perimenopausal Women, Depressed, Following Estradiol Treatment Perimenopausal Women, Non-depressed, Following Estradiol
Hide Arm/Group Description:

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Overall Number of Participants Analyzed 16 19 16 19
Mean (Standard Error)
Unit of Measure: score on a scale
24.56  (1.47) 13.79  (1.35) 15.25  (1.13) 11.84  (1.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Perimenopausal Women, Depressed, Baseline, Perimenopausal Women, Non-depressed, Baseline, Perimenopausal Women, Depressed, Following Estradiol Treatment, Perimenopausal Women, Non-depressed, Following Estradiol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0002
Comments [Not Specified]
Method Repeated measures ANOVA
Comments F(1,33)=17.91
Time Frame Adverse event data was tracked over a participants time in the protocol (1 month), all unresolved adverse events were tracked by the investigator until the events were resolved, the subject was lost to follow-up, or the adverse event was otherwise explained.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Hide Arm/Group Description

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Participants will receive transdermal estradiol (100μg/day) for 3 weeks. Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

Estradiol: Participants will receive transdermal estradiol (100μg/day) for 3 weeks

Progesterone: Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.

All-Cause Mortality
Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/31 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Perimenopausal Women, Depressed Perimenopausal Women, Non-depressed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/33 (48.48%)      17/31 (54.84%)    
Endocrine disorders     
Bloating * [1]  2/33 (6.06%)  2 2/31 (6.45%)  2
Hot Flashes *  2/33 (6.06%)  2 1/31 (3.23%)  1
Gastrointestinal disorders     
Nausea *  3/33 (9.09%)  3 2/31 (6.45%)  2
General disorders     
Waking during the night *  0/33 (0.00%)  0 2/31 (6.45%)  2
Lower Back Pain *  2/33 (6.06%)  2 0/31 (0.00%)  0
Nervous system disorders     
Headaches *  4/33 (12.12%)  4 4/31 (12.90%)  4
Dizziness *  1/33 (3.03%)  1 2/31 (6.45%)  2
Reproductive system and breast disorders     
Breast Tenderness * [2]  6/33 (18.18%)  6 3/31 (9.68%)  3
Cramps * [3]  5/33 (15.15%)  5 3/31 (9.68%)  3
Menstrual Bleeding *  2/33 (6.06%)  2 2/31 (6.45%)  2
Skin and subcutaneous tissue disorders     
Itchiness at patch site *  5/33 (15.15%)  5 4/31 (12.90%)  4
Acne *  2/33 (6.06%)  2 0/31 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Water retention or bloating
[2]
Breast fullness or tenderness.
[3]
menstrual type cramps, abdominal pain and tenderness, sensitive groin
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Crystal Edler Schiller, PhD
Organization: UNC School of Medicine
Phone: 919-966-4810
EMail: crystal_schiller@med.unc.edu
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02255175    
Other Study ID Numbers: 13-3572
K12HD001441-15 ( U.S. NIH Grant/Contract )
K23MH105569-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 29, 2014
First Posted: October 2, 2014
Results First Submitted: September 25, 2019
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019