A Study of AZD4901 in Females With Polycystic Ovary Syndrome
NCT ID: NCT01872078
Last Updated: 2015-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2013-06-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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AZD4901 20 mg once a day
AZD4901 20 mg once a day
AZD4901 (oral)
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
AZD4901 20mg twice a day
AZD4901 20mg twice a day
AZD4901 (oral)
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
AZD4901 40 mg twice a day
AZD4901 40 mg twice a day
AZD4901 (oral)
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
Placebo to match AZD4901
Placebo to match AZD4901
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
Interventions
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AZD4901 (oral)
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
Placebo to match AZD4901
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.
18 Years
45 Years
FEMALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jyothis George, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Miami Research Associates
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Springfield, Missouri, United States
Research Site
Berlin, , Germany
Research Site
Belfast, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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George JT, Kakkar R, Marshall J, Scott ML, Finkelman RD, Ho TW, Veldhuis J, Skorupskaite K, Anderson RA, McIntosh S, Webber L. Neurokinin B Receptor Antagonism in Women With Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4313-4321. doi: 10.1210/jc.2016-1202. Epub 2016 Jul 26.
Other Identifiers
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D5320C00001
Identifier Type: -
Identifier Source: org_study_id
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