Polycystic Ovary Syndrome MedDRA version: 20.0 Level: PT Classification code 10036049 Term: Polycystic ovaries System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Code: AZD4901
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: -
CAS Number: 941690-55-7
Current Sponsor code: AZD49
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients between the ages of 18 to 45 years (inclusive) with 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 oligomenorrrhea (defined as = 6 menses per year) -Females must have a negative serum pregnancy test at screening and a negative urine pregnancy test before randomisation, must not be breast-feeding, must not have been pregnant within the 6 months prior to screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Is perimenopausal or has reached natural menopause, defined as FSH > 10 IU/L -Has menstruated within the month prior to the baseline visit -Patients who have had a hysterectomy or bilateral oophorectomy or both -Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding -Patients who are withdrawing from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To determine the change from baseline of free and total testosterone on Days 7 and 28 •To assess the safety and tolerability of multiple dosing of AZD4901 in patients with PCOS •To measure AZD4901 and its active metabolite plasma exposure in patients with PCOS •To evaluate the PK/pharmacodynamic (PD) relationship of AZD4901 and LH and testosterone ;Main Objective: To determine change from baseline of LH area under the concentration curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7 in comparison to placebo.; Primary end point(s): Change from baseline at Day 7 in Luteinizing hormone AUC(0-8) ;Timepoint(s) of evaluation of this end point: Day-1 and Day7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety variables -Change from baseline at Day 7 (free and total testosterone) - Change from baseline at Day 28 (free and total testosterone) - AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: AUC(0-8 hours), Cmin, and Cmax; the ratio of active metabolite Cmax to AZD4901 Cmax; the ratio of active metabolite AUC(0-8) to AZD4901 AUC(0-8)) - AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: AUC(0-8hours), Cmin, and Cmax; the ratio of active metabolit Cmax to AZD4901 Cmax; the ratio of active metabolite AUC(0-8) to AZD4901 AUC(0-8)) -PK/PD relationship between AZD4901 plasma concentration and LH and testosterone levels - 4-ß-OH cholesterol ratio of post treatment:pre treatment concentration - 6-ß-OH testosterone ratio of post treatment:pre treatment concentration ; Timepoint(s) of evaluation of this end point: PD parameters: Baseline, day 0, Day 7, Day 28; PK parameters: Day 7 and Day 28: Safety: Up to 85 days for safety variables PK/PD relationship: cholesterol ratio; testosterone ratio: Throughout baseline to day 28 | — |
Countries
Germany, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed