A Study of AZD4901 in Females With Polycystic Ovary Syndrome



Status:Completed
Conditions:Women's Studies, Endocrine
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:June 2013
End Date:July 2014

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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

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


Inclusion Criteria:

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 Criteria:

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.
We found this trial at
4
sites
Miami, Florida
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Miami, FL
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Berlin,
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Orlando, FL
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Springfield, MO
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