Study S000534

A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)

Included trial: extracted data ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)Informed Consent Form (PDF)

Registration

Registration: NCT03480022
Acronym: SAXAPCOS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 88
Start: 2018-09-26
Primary completion: 2021-02-22
Lead sponsor: Woman's
Conditions: Pre Diabetes; Polycystic Ovary Syndrome; Obesity Android
Interventions: DRUG:Liraglutide Pen Injector [Saxenda]; DRUG:Placebo Liraglutide Pen Injector
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Absolute Body Weight (BW) [32 weeks of treatment]
Free Androgen Index (FAI) [32 weeks of treatment]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0020654	Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study. Elkind-Hirsch KE, Fertility and sterility	2022	Randomized trial	PMID 35710599 DOI	cites ClinicalTrials.gov:NCT03480022; registry reference DERIVED:35710599
R0022023	A randomized, double-blind, placebo-controlled study of liraglutide 3 mg [LIRA 3mg] on weight, body composition, hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome (PCOS) Elkind-Hirsch K, Research Square	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03480022