A Study of AZD4901 in Females With Polycystic Ovary Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder

In brief

To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome

Key facts

Study ID

NCT01872078

Run by

AstraZeneca

People needed

67

Starts

2013-06-01

Expected to finish

2014-07-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.