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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01403038
Phase
PHASE1
Status
Completed

Conditions

  • Folliculogenesis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Elagolix — DRUG
    Elagolix Dose Regimen 1 for 84 days
  • Elagolix — DRUG
    Elagolix Dose Regimen 2 for 84 days
  • Elagolix — DRUG
    Elagolix Dose Regimen 3 for 84 days
  • Elagolix — DRUG
    Elagolix Dose Regimen 4 for 84 days Other interventions may be added
  • Elagolix — DRUG
    Elagolix Dose Regimen 5 for 84 days
  • Elagolix — DRUG
    Elagolix Dose Regimen 6 for 84 days
  • elagolix — DRUG
    Elagolix plus Activella Dose Regimen 7 for 84 days

Study Details

This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.

Key Dates

Start date
Jun 30, 2011
Status verified
Jan 2013
Primary completion
Oct 31, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Elagolix Dose Regimen 1
    Elagolix Dose regimen 1 for 84 days
  • Experimental: Elagolix Dose Regimen 2
    Elagolix Dose Regimen 2 for 84 days
  • Experimental: Elagolix Dose Regimen 3
    Elagolix Dose Regimen 3 for 84 days
  • Experimental: Elagolix Dose Regimen 4
    Elagolix Dose Regimen 4 for 84 days Additional Dose Regimens may be added and will be administered for 84 days.
  • Experimental: Elagolix Dose Regimen 5
    Elagolix Dose Regimen 5 for 84 days
  • Experimental: Elagolix Dose Regimen 6
    Elagolix Dose Regimen 6 for 84 days
  • Experimental: Elagolix Dose Regimen 7
    Elagolix Dose Regimen 7 for 84 days

Primary Outcome Measure

Ovulation Classification [ Time Frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. ]

Locations (20)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 50805Colorado SpringsColorado80910-
Site Reference ID/Investigator# 51270Colorado SpringsColorado80917-
Site Reference ID/Investigator# 50884DenverColorado80246-
Site Reference ID/Investigator# 50404LonetreeColorado80124-
Site Reference ID/Investigator# 50904MiamiFlorida33126-
Site Reference ID/Investigator# 50402South MiamiFlorida33143-
Site Reference ID/Investigator# 50808TampaFlorida33606-
Site Reference ID/Investigator# 50807NapervilleIllinois60540-
Site Reference ID/Investigator# 50804Oak BrookIllinois60523-
Site Reference ID/Investigator# 50762DurhamNorth Carolina27713-
Site Reference ID/Investigator# 50403Winston-SalemNorth Carolina27103-
Site Reference ID/Investigator# 50810CincinnatiOhio45267-0457-
Site Reference ID/Investigator# 50883PortlandOregon97239-
Site Reference ID/Investigator# 50803PhiladelphiaPennsylvania19104-
Site Reference ID/Investigator# 51546PhiladelphiaPennsylvania19114-
Site Reference ID/Investigator# 50806San AntonioTexas78229-
Site Reference ID/Investigator# 51342San AntonioTexas78229-
Site Reference ID/Investigator# 50811Sandy CityUtah84070-
Site Reference ID/Investigator# 50902NorfolkVirginia23507-
Site Reference ID/Investigator# 50882SeattleWashington98105-

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Site Reference ID/Investigator# 50805· Colorado Springs, COSite Reference ID/Investigator# 51270· Colorado Springs, COSite Reference ID/Investigator# 50884· Denver, COSite Reference ID/Investigator# 50404· Lonetree, COSite Reference ID/Investigator# 50904· Miami, FLSite Reference ID/Investigator# 50402· South Miami, FL