Effects of an ER Beta Agonist (Lilly Compound LY500307) on Estradiol-Withdrawal-Induced Mood Symptoms in Women With Past Perimenopausal Depression
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|ClinicalTrials.gov Identifier: NCT03689543|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 8, 2020
Some women who had depression in the perimenopause may have mood symptoms again if they stop estrogen therapy. Estrogen acts in the brain and other tissues by binding to at least three types of estrogen receptors. One of these receptors, estrogen receptor beta may affect anxiety and depression. The drug LY500307 acts only on this receptor. In this study, researchers will initially give you estrogen and then suddenly stop estrogen after three weeks. Then they will study how LY500307 affects mood symptoms.
To study how withdrawing estradiol affects mood. To test the safety and side effects of LY500307.
Healthy women ages 45-65 who had depression related to perimenopause in recent years and whose mood systems got better with estradiol
-Participants will be screened with:
- Participants able to get pregnant must use effective barrier birth control throughout the study.
- During the first 3 weeks, participants will wear an estrogen patch. It is 1x2 inches and will be replaced every 3 days.
- For the next 3 weeks, participants will take 3 study capsules every morning. They will not know if they get the study drug or placebo.
- Some participants will also take a progesterone-like drug for 1 week at the end of the medication phase of the study.
- Participants will have 9 one-hour study visits. They will have blood samples and vital signs taken. They will answer questions about mood and behavior symptoms.
- Participants will keep a daily log of these symptoms.
- Participants will have 2 transvaginal ultrasounds. A probe is temporarily placed 2-3 inches into the vaginal canal and sound waves are used to create pictures of the lining of the uturus.
- Participants will have a final visit 4 weeks after stopping the study drug. They will answer questions about mood and side effects.
|Condition or disease||Intervention/treatment||Phase|
|Perimenopausal Depression||Drug: ER beta agonist Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of an ER Beta Agonist (Lilly Compound LY500307) on Estradiol-withdrawal-induced Mood Symptoms in Women With Past Perimenopausal Depression.|
|Actual Study Start Date :||May 23, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Arm 1
all women receive open label (OL) estradiol therapy (ET) at a dose of 100 micrograms per day bytransdermal skin patch
Drug: ER beta agonist
Lilly Compound LY500307
Experimental: Arm 2
all women receive three weeks of double blind (DB) medication (i.e., LY500307 [at a daily dose of either 25 mg or 75 mg] or placebo)
Drug: ER beta agonist
Lilly Compound LY500307
Placebo Comparator: Arm 3
- Epidemiologic Studies-Depression Scale (CES-D) [ Time Frame: Ongoing ]Epidemiologic Studies-Depression Scale (CES-D)
- bserver ratings - the 17-item Hamilton Rating Scale of Depression(HRSD) [ Time Frame: Ongoing ]bserver ratings - the 17-item Hamilton Rating Scale of Depression(HRSD)
- endometrial thickness as measured by vaginal ultrasound [ Time Frame: ongoing ]
- Plasma LH, FSH, prolactin, and lipid levels [ Time Frame: Ongoing ]
- Visual analogue scale (VAS) [ Time Frame: Ongoing ]
- Beck Depression Inventory (BDI) [ Time Frame: Ongoing ]
- 14 item six point likert-type scale [ Time Frame: Ongoing ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689543
|Contact: Peter J Schmidt, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Peter J Schmidt, M.D.||National Institute of Mental Health (NIMH)|