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A Study of AZD4901 in Females With Polycystic Ovary Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of AZD4901 in Females With Polycystic Ovary Syndrome

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

NCT01872078•AstraZeneca

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (7)

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

Key Dates

Start Date

June 1, 2013

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

October 12, 2015

Enrollment

ACTUAL participants

Conditions

Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder

Interventions

AZD4901 (oral)

DRUG

Placebo to match AZD4901

DRUG