Trial Outcomes & Findings for Estrogen Receptor Beta and Mood (NCT NCT03689543)

Last Updated: 2025-09-16

Results Overview

Center for Epidemiologic Studies-Depression (CES-D) Scale is a 20-item questionnaire that asks participants to rate how often over the past week they experienced symptoms associated with depression. Each item is rated from 0 to 3 (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D scores \>8 and \<16 is consistent with subsyndromal depression. CES-D scores \> 16 are consistent with clinically significant depressive symptoms of at least moderate severity. Participants completed the CES-D at baseline and every week for six weeks during each of the study phases (open label estradiol patch, double blind placebo or LY500307 compound). Analysis was calculated as the mean of scores for baseline (week 0) and weekly through week six (6).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Baseline, then weekly through end of week six

Results posted on

2025-09-16

Participant Flow

of the 74 participants consented to study, 19 participants failed screening and nine (9) dropped out prior to randomization

Participant milestones

Participant milestones
Measure	Arm 1: High Dose LY500307 Compound Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received LY500307 compound 75mg orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 2: Low Dose LY500307 Compound Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received a combination of LY500307 compound 25mg and placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 3: Placebo Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.
Overall Study STARTED	15	15	16
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: High Dose LY500307 Compound Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received LY500307 compound 75mg orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 2: Low Dose LY500307 Compound Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received a combination of LY500307 compound 25mg and placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 3: Placebo Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Estrogen Receptor Beta and Mood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: High Dose LY500307 Compound n=15 Participants Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received LY500307 compound 75mg orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 2: Low Dose LY500307 Compound n=15 Participants Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received a combination of LY500307 compound 25mg and placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 3: Placebo n=16 Participants Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Total n=46 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
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	46 Participants n=4 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
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	46 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
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 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
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, then weekly through end of week six

Population: All participants who were randomized to arms in the study. One participant dropped out at week 5 therefore did not complete week 6 questionnaire.

Outcome measures

Outcome measures
Measure	Arm 1: High Dose LY500307 Compound n=15 Participants Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received LY500307 compound 75mg orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 2: Low Dose LY500307 Compound n=15 Participants Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received a combination of LY500307 compound 25mg and placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.	Arm 3: Placebo n=16 Participants Female participants received open label estradiol 0.1mg transdermal patch per day for three weeks. Then participants received placebo orally once per day for three weeks under double blind conditions. Participants with a uterus received Provera 5mg orally once a day for one week after completion of randomization.
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Week 1	9.43 Units on a scale Standard Deviation 7.11	10.67 Units on a scale Standard Deviation 8.01	5.38 Units on a scale Standard Deviation 6.83
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Baseline	12.96 Units on a scale Standard Deviation 9.06	18.02 Units on a scale Standard Deviation 11.27	11.53 Units on a scale Standard Deviation 9.03
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Week 2	4.27 Units on a scale Standard Deviation 4.22	5.60 Units on a scale Standard Deviation 4.70	3.44 Units on a scale Standard Deviation 3.83
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Week 3	3.47 Units on a scale Standard Deviation 4.09	4.13 Units on a scale Standard Deviation 3.87	2.25 Units on a scale Standard Deviation 2.82
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Week 4	5.60 Units on a scale Standard Deviation 5.45	5.27 Units on a scale Standard Deviation 5.08	5.19 Units on a scale Standard Deviation 7.20
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Week 5	7.47 Units on a scale Standard Deviation 11.36	5.47 Units on a scale Standard Deviation 5.18	8.25 Units on a scale Standard Deviation 9.55
Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score Week 6	8.40 Units on a scale Standard Deviation 11.19	6.00 Units on a scale Standard Deviation 6.37	9.93 Units on a scale Standard Deviation 9.32

PRIMARY outcome

Timeframe: Baseline, then weekly through end of week six

Population: All participants who were randomized to arms in the study. One participant dropped out at week 5 therefore did not complete week 6 questionnaire.

The Hamilton Rating Scale of Depression (HRSD) is a 21-item scale used by clinicians to assess the severity of depressive symptoms administered through a structured interview. The HRSD contains 21 items, but four questions are not added to the numerical total score. The first 17 items are scored on a 3 (0-2) or 5 (0-4) point scale, with total score range between 0 and 52. Higher score indicates greater depressive symptom. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. Participants completed the HRSD at baseline and every week for six weeks during each of the study phases (open label estradiol patch, double blind placebo or LY500307 compound). Analysis was calculated as the mean of scores for baseline (week 0) and weekly through week six (6).