NCT01403038

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2011

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

June 1, 2011

Last Update Submit

January 4, 2013

Conditions

Folliculogenesis

Keywords

healthy volunteerselagolixendometriosisovarian reservegonadotropin-releasing hormone antagonistovulationovarian activity

Outcome Measures

Primary Outcomes (2)

  • Ovulation Classification

    Presence or absence of ovulation

    During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.

  • Ovarian Activity

    As measured by the Hoogland and Skouby 6-point ovarian activity grading system

    During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.

Secondary Outcomes (6)

  • Endocrine Parameters

    During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3

  • Ovarian Reserve

    During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.

  • Adverse events

    All adverse events occurring through the Final Visit will be reported

  • Clinical Laboratory Tests

    Change from baseline to Cycles 1, 2, and 3 or Final Visit

  • 12-lead Electrocardiogram

    Change from baseline to Week 4 and Final Visit

  • +1 more secondary outcomes

Study Arms (7)

Elagolix Dose Regimen 1

EXPERIMENTAL

Elagolix Dose regimen 1 for 84 days

Drug: Elagolix

Elagolix Dose Regimen 2

EXPERIMENTAL

Elagolix Dose Regimen 2 for 84 days

Drug: Elagolix

Elagolix Dose Regimen 3

EXPERIMENTAL

Elagolix Dose Regimen 3 for 84 days

Drug: Elagolix

Elagolix Dose Regimen 4

EXPERIMENTAL

Elagolix Dose Regimen 4 for 84 days Additional Dose Regimens may be added and will be administered for 84 days.

Drug: Elagolix

Elagolix Dose Regimen 5

EXPERIMENTAL

Elagolix Dose Regimen 5 for 84 days

Drug: Elagolix

Elagolix Dose Regimen 6

EXPERIMENTAL

Elagolix Dose Regimen 6 for 84 days

Drug: Elagolix

Elagolix Dose Regimen 7

EXPERIMENTAL

Elagolix Dose Regimen 7 for 84 days

Drug: elagolix

Interventions

elagolixDRUG

Elagolix Dose Regimen 1 for 84 days

Also known as: ABT-620, elagolix sodium
Elagolix Dose Regimen 1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Premenopausal female, between 18 and 40 years of age, inclusive - History of regular menstrual cycles - Endocrine and ultrasonographic evidence of ovulation and normal ovulatory cycle during the screening period - Follicle-stimulating hormone level of \<35 mIU/mL - Agrees to use required birth control methods during the entire length of participation in the study

You may not qualify if:

  • \- Screening ultrasound results show a clinically significant gynecological disorder - Surgical history of hysterectomy without oophorectomy, unilateral or bilateral oophorectomy, removal of ovarian cysts - Less than 6 months postpartum or post-lactation at the start of study drug dosing - Pregnant or breast feeding or is planning a pregnancy within the next 12 months - Testosterone concentration \>120 ng/dL at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Site Reference ID/Investigator# 50805

Colorado Springs, Colorado, 80910, United States

Location

Site Reference ID/Investigator# 51270

Colorado Springs, Colorado, 80917, United States

Location

Site Reference ID/Investigator# 50884

Denver, Colorado, 80246, United States

Location

Site Reference ID/Investigator# 50404

Lonetree, Colorado, 80124, United States

Location

Site Reference ID/Investigator# 50904

Miami, Florida, 33126, United States

Location

Site Reference ID/Investigator# 50402

South Miami, Florida, 33143, United States

Location

Site Reference ID/Investigator# 50808

Tampa, Florida, 33606, United States

Location

Site Reference ID/Investigator# 50807

Naperville, Illinois, 60540, United States

Location

Site Reference ID/Investigator# 50804

Oak Brook, Illinois, 60523, United States

Location

Site Reference ID/Investigator# 50762

Durham, North Carolina, 27713, United States

Location

Site Reference ID/Investigator# 50403

Winston-Salem, North Carolina, 27103, United States

Location

Site Reference ID/Investigator# 50810

Cincinnati, Ohio, 45267-0457, United States

Location

Site Reference ID/Investigator# 50883

Portland, Oregon, 97239, United States

Location

Site Reference ID/Investigator# 50803

Philadelphia, Pennsylvania, 19104, United States

Location

Site Reference ID/Investigator# 51546

Philadelphia, Pennsylvania, 19114, United States

Location

Site Reference ID/Investigator# 50806

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 51342

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 50811

Sandy City, Utah, 84070, United States

Location

Site Reference ID/Investigator# 50902

Norfolk, Virginia, 23507, United States

Location

Site Reference ID/Investigator# 50882

Seattle, Washington, 98105, United States

Location

Site Reference ID/Investigator# 53363

San Juan, 00935, Puerto Rico

Location

Site Reference ID/Investigator# 53362

Santurce, 00910, Puerto Rico

Location

Related Publications (2)

  • Archer DF, Ng J, Chwalisz K, Chiu YL, Feinberg EC, Miller CE, Feldman RA, Klein CE. Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz086. doi: 10.1210/clinem/dgz086.

    PMID: 31650182DERIVED

  • Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6.

    PMID: 29476499DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

elagolix

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kristof Chwalisz, MD, PhD, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

July 27, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(20)PR(2)