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 |
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
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.
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