An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

PHASE1CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

November 30, 2012

Conditions
Folliculogenesis
Interventions
DRUG

Elagolix

Elagolix Dose Regimen 1 for 84 days

DRUG

Elagolix

Elagolix Dose Regimen 2 for 84 days

DRUG

Elagolix

Elagolix Dose Regimen 3 for 84 days

DRUG

Elagolix

Elagolix Dose Regimen 4 for 84 days Other interventions may be added

DRUG

Elagolix

Elagolix Dose Regimen 5 for 84 days

DRUG

Elagolix

Elagolix Dose Regimen 6 for 84 days

DRUG

elagolix

Elagolix plus Activella Dose Regimen 7 for 84 days

Trial Locations (22)

19104

Site Reference ID/Investigator# 50803, Philadelphia

19114

Site Reference ID/Investigator# 51546, Philadelphia

23507

Site Reference ID/Investigator# 50902, Norfolk

27103

Site Reference ID/Investigator# 50403, Winston-Salem

27713

Site Reference ID/Investigator# 50762, Durham

33126

Site Reference ID/Investigator# 50904, Miami

33143

Site Reference ID/Investigator# 50402, South Miami

33606

Site Reference ID/Investigator# 50808, Tampa

60523

Site Reference ID/Investigator# 50804, Oak Brook

60540

Site Reference ID/Investigator# 50807, Naperville

78229

Site Reference ID/Investigator# 50806, San Antonio

Site Reference ID/Investigator# 51342, San Antonio

80124

Site Reference ID/Investigator# 50404, Lonetree

80246

Site Reference ID/Investigator# 50884, Denver

80910

Site Reference ID/Investigator# 50805, Colorado Springs

80917

Site Reference ID/Investigator# 51270, Colorado Springs

84070

Site Reference ID/Investigator# 50811, Sandy City

97239

Site Reference ID/Investigator# 50883, Portland

98105

Site Reference ID/Investigator# 50882, Seattle

45267-0457

Site Reference ID/Investigator# 50810, Cincinnati

00935

Site Reference ID/Investigator# 53363, San Juan

00910

Site Reference ID/Investigator# 53362, Santurce

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Neurocrine Biosciences

INDUSTRY

lead

AbbVie (prior sponsor, Abbott)

INDUSTRY