Trial Outcomes & Findings for The Effects of Reproductive Hormones on Mood and Behavior (NCT NCT00001322)
NCT ID: NCT00001322
Last Updated: 2022-03-22
Results Overview
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures the severity of symptoms accompanying depression. Each item has a minimum score of 0 and a maximum score of 3, with higher numbers consistent with more severe symptoms. The score of each item is summed to amount the overall BDI score, with a minimum score of 0 and a maximum score of 63. Higher BDI scores are consistent with more severe depression. Score of 16 or greater is consistent with clinical depression. Each participant completed the BDI every 2 weeks during each of the study phases (i.e., GnRH agonist alone, estradiol and progesterone) throughout the 6-month study. Outcome measures reported consist of the average of two BDI scores from each phase of the study: the last 4 weeks of the GnRH agonist alone (phase 1), during the 4-week long estradiol phase (phase 2: weeks 2 and 4 of estradiol) and the 4-week long progesterone phase (phase 2: weeks 2 and 4 of progesterone).
COMPLETED
PHASE1/PHASE2
100 participants
Phase 1: Weeks 6 and 8 or 10 and 12; Phase 2: Weeks 2 and 4 of estradiol or progesterone
2022-03-22
Participant Flow
4 participants were screen failures, 4 withdrew prior to start of study and 92 started and completed phase 1 the study. 10 participants did not proceed to phase 2 (crossover arm) of the study.
Participant milestones
| Measure |
Phase 1 - Lupron
Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
|
Phase 2, Arm 1 - Estradiol, Then Progesterone
12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly. Additionally, 4 weeks of transdermal Estradiol (100mcg/day by skin patch) and placebo suppositories. Week 5 involves 100mcg/day transdermal Estradiol and active Progesterone suppositories (200mg vaginally twice/day). Followed by 1-2 weeks (weeks 6-7) washout period. Then crossover to 5 weeks (week 8-12) of Progesterone suppositories (200mg vaginally twice/day) and placebo patches.
|
Phase 2, Arm 2 - Progesterone, Then Estradiol
12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly. Additionally, 5 weeks of Progesterone suppositories (200mg vaginally twice/day) and placebo patches. Followed by 1-2 weeks (weeks 6-7) washout period. Then crossover to 4 weeks (weeks 8-11) of transdermal Estradiol (100mcg/day by skin patch) and placebo suppositories. Week 12 involves 100mcg/day transdermal Estradiol and active Progesterone suppositories (200mg vaginally twice/day).
|
|---|---|---|---|
|
Phase 1 - Lupron Only
STARTED
|
92
|
0
|
0
|
|
Phase 1 - Lupron Only
COMPLETED
|
92
|
0
|
0
|
|
Phase 1 - Lupron Only
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2, Period 1 - Crossover Phase
STARTED
|
0
|
42
|
40
|
|
Phase 2, Period 1 - Crossover Phase
COMPLETED
|
0
|
42
|
40
|
|
Phase 2, Period 1 - Crossover Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2, Period 2 - Crossover Phase
STARTED
|
0
|
42
|
40
|
|
Phase 2, Period 2 - Crossover Phase
COMPLETED
|
0
|
42
|
40
|
|
Phase 2, Period 2 - Crossover Phase
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Reproductive Hormones on Mood and Behavior
Baseline characteristics by cohort
| Measure |
Phase 1 - Lupron
n=92 Participants
Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly before randomization to estradiol or progesterone arm in the crossover phase of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
92 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase 1: Weeks 6 and 8 or 10 and 12; Phase 2: Weeks 2 and 4 of estradiol or progesteronePopulation: Analyses included comparison of mean BDI scores during each phase of the study
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures the severity of symptoms accompanying depression. Each item has a minimum score of 0 and a maximum score of 3, with higher numbers consistent with more severe symptoms. The score of each item is summed to amount the overall BDI score, with a minimum score of 0 and a maximum score of 63. Higher BDI scores are consistent with more severe depression. Score of 16 or greater is consistent with clinical depression. Each participant completed the BDI every 2 weeks during each of the study phases (i.e., GnRH agonist alone, estradiol and progesterone) throughout the 6-month study. Outcome measures reported consist of the average of two BDI scores from each phase of the study: the last 4 weeks of the GnRH agonist alone (phase 1), during the 4-week long estradiol phase (phase 2: weeks 2 and 4 of estradiol) and the 4-week long progesterone phase (phase 2: weeks 2 and 4 of progesterone).
Outcome measures
| Measure |
Phase 1 - Lupron
n=92 Participants
Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
|
Phase 2 - Estradiol
n=82 Participants
4 weeks of transdermal Estradiol (100mcg/day by skin patch) and placebo suppositories. Week 5 involves 100mcg/day transdermal Estradiol and active Progesterone suppositories (200mg vaginally twice/day).
|
Phase 2 - Progesterone
n=82 Participants
5 weeks of Progesterone suppositories (200mg vaginally twice/day) and placebo patches.
|
|---|---|---|---|
|
Mean Beck Depression Inventory Score
|
1.4 Units on a scale
Standard Deviation 2.1
|
1 Units on a scale
Standard Deviation 2
|
1.1 Units on a scale
Standard Deviation 1.8
|
Adverse Events
Lupron
Phase 2 - Estradiol
Phase 2 - Progesterone
Serious adverse events
| Measure |
Lupron
n=92 participants at risk
Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
|
Phase 2 - Estradiol
n=82 participants at risk
4 weeks of transdermal Estradiol (100mcg/day by skin patch)
|
Phase 2 - Progesterone
n=82 participants at risk
5 weeks of Progesterone suppositories (200mg vaginally twice/day)
|
|---|---|---|---|
|
Reproductive system and breast disorders
Breast fibroma
|
1.1%
1/92 • 6 months
|
0.00%
0/82 • 6 months
|
0.00%
0/82 • 6 months
|
Other adverse events
| Measure |
Lupron
n=92 participants at risk
Eight to 12 weeks of GnRH agonist treatment 3.75 mg given intramuscularly monthly.
|
Phase 2 - Estradiol
n=82 participants at risk
4 weeks of transdermal Estradiol (100mcg/day by skin patch)
|
Phase 2 - Progesterone
n=82 participants at risk
5 weeks of Progesterone suppositories (200mg vaginally twice/day)
|
|---|---|---|---|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.1%
1/92 • 6 months
|
0.00%
0/82 • 6 months
|
0.00%
0/82 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/92 • 6 months
|
1.2%
1/82 • 6 months
|
0.00%
0/82 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place