A Study of AZD4901 in Females With Polycystic Ovary Syndrome

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
• Interventions: Drug: AZD4901 (oral); Drug: Placebo to match AZD4901

• Registration Number: NCT01872078
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-23
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-07-22
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-14
• Last Update Submitted: 2015-09-14
• Results First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD4901 20 mg once a day	AZD4901 (oral)	AZD4901 20 mg once a day
AZD4901 20mg twice a day	AZD4901 (oral)	AZD4901 20mg twice a day
AZD4901 40 mg twice a day	AZD4901 (oral)	AZD4901 40 mg twice a day
Placebo to match AZD4901	Placebo to match AZD4901	-

Primary Outcome Measures

Name	Time	Method
Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7	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

Trial Locations

Locations (2)

Research Site; 🇬🇧 London, United Kingdom

Miami Research Associates; 🇺🇸 Miami, Florida, United States