To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary SyndromeMedDRA version: 20.0 Level: PT Classification code 10036049 Term: Polycystic ovaries System Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2013-000788-98-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: • To determine the change from baseline of free and total testosterone on Days 7 and 28<br> •To assess the safety and tolerability of multiple dosing of AZD4901 in patients with PCOS <br> •To measure AZD4901 and its active metabolite plasma exposure in patients with PCOS <br> •To evaluate the PK/pharmacodynamic (PD) relationship of AZD4901 and LH and testosterone<br> ;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.;<br> Primary end point(s): Change from baseline at Day 7 in Luteinizing hormone AUC(0-8) <br> ;Timepoint(s) of evaluation of this end point: Day-1 and Day7
- Secondary Outcome Measures
Name Time Method