A Study of AZD4901 in Females With Polycystic Ovary Syndrome

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder

Treatments: Drug: AZD4901 (oral); Drug: Placebo to match AZD4901

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872078

D5320C00001

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 4 patient groups

AZD4901 20 mg once a day

Experimental group

Description:

AZD4901 20 mg once a day

Treatment:

Drug: AZD4901 (oral)

AZD4901 20mg twice a day

Experimental group

Description:

AZD4901 20mg twice a day

Treatment:

Drug: AZD4901 (oral)

AZD4901 40 mg twice a day

Experimental group

Description:

AZD4901 40 mg twice a day

Treatment:

Drug: AZD4901 (oral)

Placebo to match AZD4901

Experimental group

Treatment:

Drug: Placebo to match AZD4901