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

NCT01403038 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2013-01-08

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • Neurocrine Biosciences

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Kristof Chwalisz, MD, PhD, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01403038 on ClinicalTrials.gov