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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


Phase 2
18 Years
45 Years
Not Enrolling
Female
Polycycstic Ovary Syndrome (PCOS), Female Endocrine Disorder

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Trial Information

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


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 oligomenorrrhea (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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Time Frame:

Day-1 and Day7

Safety Issue:

No

Principal Investigator

Jyothis George, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Edinburgh

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D5320C00001

NCT ID:

NCT01872078

Start Date:

June 2013

Completion Date:

March 2014

Related Keywords:

  • Polycycstic Ovary Syndrome (PCOS), Female Endocrine Disorder
  • Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH
  • Endocrine System Diseases
  • Polycystic Ovary Syndrome

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