A Study of AZD4901 in Females With Polycystic Ovary Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01872078
First received: May 23, 2013
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
Drug: AZD4901 (oral)
Drug: Placebo to match AZD4901
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline at Day 7 in Luteinizing hormone AUC(0-8) [ Time Frame: Day-1 and Day7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, physical exam, vital signs, ECGs, clinical laboratory safety tests C-SSRS) [ Time Frame: Up to 85 days ] [ Designated as safety issue: Yes ]
  • Change from baseline at Day 7 (free and total testosterone) [ Time Frame: Baseline (Day -1) to Day 7 ] [ Designated as safety issue: No ]
  • Change from baseline at Day 28 (free and total testosterone) [ Time Frame: Baseline (Day -1) to Day 28 ] [ Designated as safety issue: No ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: tmax, AUC(0-8 hours), Cmin, and Cmax) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: tmax, AUC(0-8hours), Cmin, and Cmax) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • The relationship between different plasma exposures/doses of AZD4901 and clinical response as measured by changes in LH and testosterone concentrations [ Time Frame: Baseline (Day -1) to Day 28 ] [ Designated as safety issue: No ]
    A mathematical model that describes the AZD4901 plasma concentration time profile, LH and testosterone concentration and the mathematical relation between AZD4901 plasma concentration and LH and testosterone.

  • 4-β-OH cholesterol ratio of post treatment:pre treatment concentration [ Time Frame: Baseline (Day -1) to Day 28 ] [ Designated as safety issue: No ]
  • 6-β-OH testosterone ratio of post treatment:pre treatment concentration [ Time Frame: Baseline (Day -1) to Day 28 ] [ Designated as safety issue: No ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: the ratio of active metabolite Cmax to AZD4901 Cmax) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: the ratio of active metabolite AUC(0-8) to AZD4901 AUC(0-8)) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: the ratio of active metabolite Cmax to AZD4901 Cmax) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: the ratio of active metabolite AUC(0-8) to AZD4901 AUC(0-8)) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD4901 20 mg once a day
AZD4901 20 mg once a day
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
Experimental: AZD4901 20mg twice a day
AZD4901 20mg twice a day
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
Experimental: AZD4901 40 mg twice a day
AZD4901 40 mg twice a day
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
Experimental: Placebo to match AZD4901 Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872078

Locations
United States, Florida
Miami Research Associates
Miami, Florida, United States
Research Site
Orlando, Florida, United States
United States, Missouri
Research Site
Springfield, Missouri, United States
Germany
Research Site
Berlin, Germany
United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jyothis George, MD University of Oxford
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01872078     History of Changes
Other Study ID Numbers: D5320C00001
Study First Received: May 23, 2013
Last Updated: July 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH

Additional relevant MeSH terms:
Endocrine System Diseases
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders

ClinicalTrials.gov processed this record on August 21, 2014