Clinical trial NCT03152591: Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Official title: A Randomized, Subject- and Investigator-blinded, Placebo-controlled Pharmacodynamic Study of Oral LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
PCOS
hyperandrogenism
insulin resistance
overweight
obesity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Change From Baseline in Luteinizing Hormone (LH) at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Androstenedione at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Total Testosterone, at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Free Androgen Index (FAI), at Day 15
timeFrame: Baseline, Day 15
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: