Status:
TERMINATED
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
Lead Sponsor:
University of California, San Francisco
Conditions:
PCOS
Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
Detailed Description
This is a single center, open-label, randomized, pilot clinical trial. Women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin D insufficient are eligible. Subje...
Eligibility Criteria
Inclusion
- Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
- Vitamin D insufficiency (serum Vitamin D \<30 ng/mL)
- Insulin resistance
- Mild or greater severity of depression by Beck Depression Inventory-II
Exclusion
- Current metformin use
- Vitamin D supplementation of \> 50,000 IU following confirmation of Vitamin D insufficiency
- Insulin-dependent diabetes mellitus
- Pregnancy or breastfeeding
- Untreated hypothyroidism
- Current active substance abuse
- Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03380091
Start Date
December 12 2017
End Date
September 1 2019
Last Update
February 9 2021
Active Locations (1)
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1
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158