Clinical Trials Register

Summary
EudraCT Number:	2013-000788-98
Sponsor's Protocol Code Number:	D5320C00001
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-04-26
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2013-000788-98

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.4.1

Sponsor's protocol code number

D5320C00001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	n/a
B.5.3.2	Town/ city	n/a
B.5.3.4	Country	United States
B.5.4	Telephone number	0018002369933
B.5.6	E-mail	information.center@astrazeneca.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	AZD4901
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.1	CAS number	941690-55-7
D.3.9.2	Current sponsor code	AZD4901
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Polycystic Ovary Syndrome

E.1.1.1

Medical condition in easily understood language

Polycystic Ovary Syndrome

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10036049
E.1.2	Term	Polycystic ovaries
E.1.2	System Organ Class	10038604 - Reproductive system and breast disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

• To determine the change from baseline of free and total testosterone on Days 7 and 28
•To assess the safety and tolerability of multiple dosing of AZD4901 in patients with PCOS
•To measure AZD4901 and its active metabolite plasma exposure in patients with PCOS
•To evaluate the PK/pharmacodynamic (PD) relationship of AZD4901 and LH and testosterone

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

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

E.4

Principal exclusion criteria

-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

E.5 End points

E.5.1

Primary end point(s)

Change from baseline at Day 7 in Luteinizing hormone AUC(0-8)

E.5.1.1

Timepoint(s) of evaluation of this end point

Day-1 and Day7

E.5.2

Secondary end point(s)

- Safety variables
-Change from baseline at Day 7 (free and total testosterone)
- Change from baseline at Day 28 (free and total testosterone)
- AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: AUC(0-8 hours), Cmin, and Cmax; the ratio of active metabolite Cmax to AZD4901 Cmax; the ratio of active metabolite AUC(0-8) to AZD4901 AUC(0-8))
- AZD4901 and its active metabolite multiple dose pharmacokinetics profile in plasma (PK parameters: AUC(0-8hours), Cmin, and Cmax; the ratio of active metabolit Cmax to AZD4901 Cmax; the ratio of active metabolite AUC(0-8) to AZD4901 AUC(0-8))
-PK/PD relationship between AZD4901 plasma concentration and LH and testosterone levels
- 4-β-OH cholesterol ratio of post treatment:pre treatment concentration
- 6-β-OH testosterone ratio of post treatment:pre treatment concentration

E.5.2.1

Timepoint(s) of evaluation of this end point

PD parameters: Baseline, day 0, Day 7, Day 28;
PK parameters: Day 7 and Day 28:
Safety: Up to 85 days for safety variables
PK/PD relationship: cholesterol ratio; testosterone ratio: Throughout baseline to day 28

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Germany

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the study is defined as ‘the last visit of the last patient undergoing the study’.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Each patient’s treatment after completion of trial will be chosen at the discretion of the investigator, and according to local clinical practice and patient need

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-07-25

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