Status:
COMPLETED
A Study of AZD4901 in Females With Polycystic Ovary Syndrome
Lead Sponsor:
AstraZeneca
Conditions:
Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion
- Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within the 6 months prior to screening.
Exclusion
- Perimenopausal or reached natural menopause, defined as FSH \> 10 IU/L. Menstruated within the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both. Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding.
- Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01872078
Start Date
June 1 2013
End Date
July 1 2014
Last Update
October 12 2015
Active Locations (7)
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1
Miami Research Associates
Miami, Florida, United States
2
Research Site
Orlando, Florida, United States
3
Research Site
Springfield, Missouri, United States
4
Research Site
Berlin, Germany