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AZD4901

Phase 2

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

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

Clinical trial landscape

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 the treatment of Polycystic Ovary Syndrome (PCOS) and Female Endocrine Disorder. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes AZD4901?

AZD4901 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical trials for endocrine conditions.

What phase is AZD4901 in?

AZD4901 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is AZD4901 in?

AZD4901 has one completed Phase 2 clinical trial, identified as NCT01872078, which studied the drug in females with Polycystic Ovary Syndrome. The trial enrolled 67 participants across the United States, Germany, and the United Kingdom.

Is AZD4901 the same as any other drug?

No alternative names for AZD4901 have been disclosed in the available information. The drug is referred to solely by its development code AZD4901 in clinical trial records and related documentation.