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A Study of AZD4901 in Females With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AZD4901 (oral)

Placebo to match AZD4901

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder focused on measuring Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

Miami Research Associates
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

AZD4901 20 mg once a day

AZD4901 20mg twice a day

AZD4901 40 mg twice a day

Placebo to match AZD4901

Arm Description

AZD4901 20 mg once a day

AZD4901 20mg twice a day

AZD4901 40 mg twice a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01872078

First Posted

May 23, 2013

Last Updated

September 14, 2015

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01872078

Brief Title

A Study of AZD4901 in Females With Polycystic Ovary Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder

Keywords

Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AZD4901 20 mg once a day

Arm Type

Experimental

Arm Description

AZD4901 20 mg once a day

Arm Title

AZD4901 20mg twice a day

Arm Type

Experimental

Arm Description

AZD4901 20mg twice a day

Arm Title

AZD4901 40 mg twice a day

Arm Type

Experimental

Arm Description

AZD4901 40 mg twice a day

Arm Title

Placebo to match AZD4901

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AZD4901 (oral)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo to match AZD4901

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 7

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jyothis George, MD

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miami Research Associates

City

Miami

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Missouri

Country

United States

Facility Name

Research Site

City

Berlin

Country

Germany

Facility Name

Research Site

City

Belfast

Country

United Kingdom

Facility Name

Research Site

City

Edinburgh

Country

United Kingdom

Facility Name

Research Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27459523

Citation

George JT, Kakkar R, Marshall J, Scott ML, Finkelman RD, Ho TW, Veldhuis J, Skorupskaite K, Anderson RA, McIntosh S, Webber L. Neurokinin B Receptor Antagonism in Women With Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4313-4321. doi: 10.1210/jc.2016-1202. Epub 2016 Jul 26.

Results Reference

derived

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A Study of AZD4901 in Females With Polycystic Ovary Syndrome

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