A Study of AZD4901 in Females With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872078
• Other study ID #: D5320C00001
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2013
• Last updated: September 14, 2015
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endocrine System Diseases
• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
• Syndrome

Intervention

Drug:
• AZD4901 (oral)
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
• Placebo to match AZD4901
Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo

Locations

Country	Name	City	State
Germany	Research Site	Berlin
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	London
United States	Miami Research Associates	Miami	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7	Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7	Day 7	No