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AZD4901

Phase 2

Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder | Small molecule | Endocrine |AstraZeneca PLC|Trials Updated: Oct 12, 2015

AZD4901 target and mechanism

ModalitySmall molecule

Also known as AZD4901 (oral)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

AZD4901 clinical trials

AZD4901 · 1 trial · 1 indication

Phase 2 1
NCT01872078A Study of AZD4901 in Females With Polycystic Ovary SyndromePolycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
COMPLETED67 Analytics
PHASE2COMPLETED
A Study of AZD4901 in Females With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Female Endocrine DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AZD4901 20 mg once a dayEXPERIMENTALAZD4901 20 mg once a day
AZD4901 20mg twice a dayEXPERIMENTALAZD4901 20mg twice a day
AZD4901 40 mg twice a dayEXPERIMENTALAZD4901 40 mg twice a day
Placebo to match AZD4901EXPERIMENTAL -

Interventions

NameTypeDescription
AZD4901 (oral)DRUGPatients 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
Placebo to match AZD4901DRUGPatients 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
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites7

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 ye...

Countries:United StatesGermanyUnited Kingdom
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Frequently asked questions about AZD4901

What is AZD4901 used for?

AZD4901 is an investigational small molecule being studied for Polycystic Ovary Syndrome (PCOS) and female endocrine disorders. It has been evaluated in a Phase 2 clinical trial in women with PCOS. It is not approved for any indication and remains in clinical development.

Who is developing AZD4901?

AZD4901 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 2 study of the drug in women with Polycystic Ovary Syndrome.

What phase is AZD4901 in?

AZD4901 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for marketing in any indication.

What clinical trials is AZD4901 in?

AZD4901 has been studied in one completed Phase 2 trial, NCT01872078, titled A Study of AZD4901 in Females With Polycystic Ovary Syndrome. The trial enrolled 67 female participants aged 18 years and older across the United States, Germany, and the United Kingdom.

Is AZD4901 the same as AZD4901 (oral)?

Yes, AZD4901 (oral) is an alternative name for AZD4901. Both refer to the same investigational small molecule developed by AstraZeneca for Polycystic Ovary Syndrome and female endocrine disorders.