Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome

Novartis Pharmaceuticals29 enrolled

Overview

The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

LIK066DRUG

LIK066 tablets for oral administration

PlaceboDRUG

Placebo tablets matching LIK066 tablets, for oral administration

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism. * Overweight/obese female subjects with BMI of 28 - 45 kg/m\^2, inclusive, and stable weight +/- 3 kg over previous 3 months * Subjects must use non-hormonal methods of contraception during the study. Key Exclusion Criteria: * Subjects with exogenous causes of hirsutism * Menstruation in the 30 days prior to screening or treatment * Pregnant or nursing (lactating) women * Use of prohibited medications * Preexisting medical condition which may significantly alter the absorption, metabolism, or excretion of the study drug, or which may jeopardize the subject in case of participation in the study

Locations (5)

Novartis Investigative Site

Springfield, Missouri, United States

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Outcomes

Primary Outcomes

Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline

Time frame: Baseline, Day 15

Secondary Outcomes

Change From Baseline in Luteinizing Hormone (LH) at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Androstenedione at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Total Testosterone, at Day 15

Time frame: Baseline, Day 15

Change From Baseline in Free Androgen Index (FAI), at Day 15

Free Androgen Index (FAI) is a ratio used to determine abnormal androgen status in humans. The ratio is the total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by 100. FAI has no units.

Time frame: Baseline, Day 15

Data from ClinicalTrials.gov

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