A Study of AZD4901 in Females With Polycystic Ovary Syndrome

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

Official Title
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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

Conditions
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Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder

Intervention / Treatment
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* Drug: AZD4901 (oral)
* Drug: Placebo to match AZD4901


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD4901 20 mg once a day<br>AZD4901 20 mg once a day | Drug: AZD4901 (oral)<br>* 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<br>|
| Experimental: AZD4901 20mg twice a day<br>AZD4901 20mg twice a day | Drug: AZD4901 (oral)<br>* 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<br>|
| Experimental: AZD4901 40 mg twice a day<br>AZD4901 40 mg twice a day | Drug: AZD4901 (oral)<br>* 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<br>|
| Experimental: Placebo to match AZD4901<br> | Drug: Placebo to match AZD4901<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH