A study of AZD4901 in females with Polycystic Ovary Syndrome
Study identifier:D5320C00001
ClinicalTrials.gov identifier:NCT01872078
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-blind, Placebo-controlled Phase IIa Study to Assess the Pharmacodynamics, Safety, and Pharmacokinetics of AZD4901 When Given in Multiple Doses to Females with Polycystic Ovary Syndrome
Medical condition
Polycystic ovary syndrome (PCOS), female endocrine disorder
Phase
Phase 2
Healthy volunteers
Yes
Study drug
AZD4901 (oral), Placebo to match AZD4901
Sex
Female
Actual Enrollment
67
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jun 2013
Primary Completion Date: 01 Jul 2014
Study Completion Date: 01 Jul 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD4901 20 mg once a day AZD4901 20 mg once a day | Drug: 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 |
| Experimental: AZD4901 20mg twice a day AZD4901 20mg twice a day | Drug: 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 |
| Experimental: AZD4901 40 mg twice a day AZD4901 40 mg twice a day | Drug: 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 |
| Experimental: Placebo to match AZD4901 | Drug: 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 |
Contacts
Investigators
Principal Investigator
Jyothis George
University of Oxford
