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A Study of AZD4901 in Females With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT01872078
Recruitment Status : Completed
First Posted : June 7, 2013
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

May 23, 2013
June 7, 2013
July 22, 2015
October 12, 2015
October 12, 2015
June 2013
July 2014   (Final data collection date for primary outcome measure)
Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 [ Time Frame: 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
Change from baseline at Day 7 in Luteinizing hormone AUC(0-8) [ Time Frame: Day-1 and Day7 ]
Complete list of historical versions of study NCT01872078 on ClinicalTrials.gov Archive Site
Not Provided
  • Safety variables (adverse events, physical exam, vital signs, ECGs, clinical laboratory safety tests C-SSRS) [ Time Frame: Up to 85 days ]
  • Change from baseline at Day 7 (free and total testosterone) [ Time Frame: Baseline (Day -1) to Day 7 ]
  • Change from baseline at Day 28 (free and total testosterone) [ Time Frame: Baseline (Day -1) to Day 28 ]
  • 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 ]
  • AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: tmax, AUC(0-8hours), Cmin, and Cmax) [ Time Frame: Day 28 ]
  • 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 ]
    A mathematical model that dsecribes 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 ]
  • 6-β-OH testosterone ratio of post treatment:pre treatment concentration [ Time Frame: Baseline (Day -1) to Day 28 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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
To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
  • 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
  • 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
  • Experimental: AZD4901 20 mg once a day
    AZD4901 20 mg once a day
    Intervention: Drug: AZD4901 (oral)
  • Experimental: AZD4901 20mg twice a day
    AZD4901 20mg twice a day
    Intervention: Drug: AZD4901 (oral)
  • Experimental: AZD4901 40 mg twice a day
    AZD4901 40 mg twice a day
    Intervention: Drug: AZD4901 (oral)
  • Experimental: Placebo to match AZD4901
    Intervention: Drug: Placebo to match AZD4901
George JT, Kakkar R, Marshall J, Scott ML, Finkelman RD, Ho TW, Veldhuis J, Skorupskaite K, Anderson RA, McIntosh S, Webber L. Neurokinin B Receptor Antagonism in Women With Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4313-4321. Epub 2016 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
56
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom,   United States
 
 
NCT01872078
D5320C00001
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Jyothis George, MD University of Oxford
AstraZeneca
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP