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

January 4, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence of significant gynecological disorders. The objective of the study is to determine the effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly. Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed frequently throughout the study. Subjects will be required to use nonhormonal dual contraception consistently during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Site Reference ID/Investigator# 53363
      • Santurce, Puerto Rico, 00910
        • Site Reference ID/Investigator# 53362
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Site Reference ID/Investigator# 50805
      • Colorado Springs, Colorado, United States, 80917
        • Site Reference ID/Investigator# 51270
      • Denver, Colorado, United States, 80246
        • Site Reference ID/Investigator# 50884
      • Lonetree, Colorado, United States, 80124
        • Site Reference ID/Investigator# 50404
    • Florida
      • Miami, Florida, United States, 33126
        • Site Reference ID/Investigator# 50904
      • South Miami, Florida, United States, 33143
        • Site Reference ID/Investigator# 50402
      • Tampa, Florida, United States, 33606
        • Site Reference ID/Investigator# 50808
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Site Reference ID/Investigator# 50807
      • Oak Brook, Illinois, United States, 60523
        • Site Reference ID/Investigator# 50804
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Site Reference ID/Investigator# 50762
      • Winston-Salem, North Carolina, United States, 27103
        • Site Reference ID/Investigator# 50403
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0457
        • Site Reference ID/Investigator# 50810
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 50883
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Site Reference ID/Investigator# 50803
      • Philadelphia, Pennsylvania, United States, 19114
        • Site Reference ID/Investigator# 51546
    • Texas
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 50806
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 51342
    • Utah
      • Sandy, Utah, United States, 84070
        • Site Reference ID/Investigator# 50811
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Site Reference ID/Investigator# 50902
    • Washington
      • Seattle, Washington, United States, 98105
        • Site Reference ID/Investigator# 50882

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elagolix Dose Regimen 1
Elagolix Dose regimen 1 for 84 days
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 2 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 3 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 5 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 6 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Experimental: Elagolix Dose Regimen 2
Elagolix Dose Regimen 2 for 84 days
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 2 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 3 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 5 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 6 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Experimental: Elagolix Dose Regimen 3
Elagolix Dose Regimen 3 for 84 days
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 2 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 3 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 5 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 6 for 84 days
Other Names:
  • ABT-620, elagolix sodium
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.
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 2 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 3 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 5 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 6 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Experimental: Elagolix Dose Regimen 5
Elagolix Dose Regimen 5 for 84 days
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 2 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 3 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 5 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 6 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Experimental: Elagolix Dose Regimen 6
Elagolix Dose Regimen 6 for 84 days
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 2 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 3 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 4 for 84 days Other interventions may be added
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 5 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Drug: Elagolix
Elagolix Dose Regimen 6 for 84 days
Other Names:
  • ABT-620, elagolix sodium
Experimental: Elagolix Dose Regimen 7
Elagolix Dose Regimen 7 for 84 days
Drug: elagolix
Elagolix plus Activella Dose Regimen 7 for 84 days
Other Names:
  • ABT-620, elagolix sodium

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Endocrine Parameters
Time Frame: During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3
Estuarial, Progesterone, luteinizing hormone, follicle stimulating hormone
During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3
Ovarian Reserve
Time Frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Inhibin-B and Antimullerian hormone
During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Adverse events
Time Frame: All adverse events occurring through the Final Visit will be reported
All adverse events will be collected by subject self-report and review of laboratory parameters, physical exam. vital sign measurements and electrocardiograms.
All adverse events occurring through the Final Visit will be reported
Clinical Laboratory Tests
Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit
Chemistry, hematology, urinalysis
Change from baseline to Cycles 1, 2, and 3 or Final Visit
12-lead Electrocardiogram
Time Frame: Change from baseline to Week 4 and Final Visit
12-lead Electrocardiogram
Change from baseline to Week 4 and Final Visit
Vital Signs
Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit
Blood pressure, heart rate, temperature
Change from baseline to Cycles 1, 2, and 3 or Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Neurocrine Biosciences

Investigators

  • Study Director: Kristof Chwalisz, MD, PhD, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M12-673

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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