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

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01403038
Collaborator
Neurocrine Biosciences (Industry)
216
22
7
17.1
9.8
0.6

Study Details

Study Description

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.

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 Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

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
  • Experimental: Elagolix Dose Regimen 2

    Elagolix Dose Regimen 2 for 84 days

    Drug: Elagolix
    Elagolix Dose Regimen 2 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 3 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 4 for 84 days Other interventions may be added
    Other Names:
  • ABT-620, elagolix sodium
  • Experimental: Elagolix Dose Regimen 5

    Elagolix Dose Regimen 5 for 84 days

    Drug: Elagolix
    Elagolix Dose Regimen 5 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 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
  • Outcome Measures

    Primary Outcome Measures

    1. Ovulation Classification [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

    2. Ovarian Activity [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

    Secondary Outcome Measures

    1. Endocrine Parameters [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

    2. Ovarian Reserve [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

    3. Adverse events [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.

    4. Clinical Laboratory Tests [Change from baseline to Cycles 1, 2, and 3 or Final Visit]

      Chemistry, hematology, urinalysis

    5. 12-lead Electrocardiogram [Change from baseline to Week 4 and Final Visit]

      12-lead Electrocardiogram

    6. Vital Signs [Change from baseline to Cycles 1, 2, and 3 or Final Visit]

      Blood pressure, heart rate, temperature

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 50805 Colorado Springs Colorado United States 80910
    2 Site Reference ID/Investigator# 51270 Colorado Springs Colorado United States 80917
    3 Site Reference ID/Investigator# 50884 Denver Colorado United States 80246
    4 Site Reference ID/Investigator# 50404 Lonetree Colorado United States 80124
    5 Site Reference ID/Investigator# 50904 Miami Florida United States 33126
    6 Site Reference ID/Investigator# 50402 South Miami Florida United States 33143
    7 Site Reference ID/Investigator# 50808 Tampa Florida United States 33606
    8 Site Reference ID/Investigator# 50807 Naperville Illinois United States 60540
    9 Site Reference ID/Investigator# 50804 Oak Brook Illinois United States 60523
    10 Site Reference ID/Investigator# 50762 Durham North Carolina United States 27713
    11 Site Reference ID/Investigator# 50403 Winston-Salem North Carolina United States 27103
    12 Site Reference ID/Investigator# 50810 Cincinnati Ohio United States 45267-0457
    13 Site Reference ID/Investigator# 50883 Portland Oregon United States 97239
    14 Site Reference ID/Investigator# 50803 Philadelphia Pennsylvania United States 19104
    15 Site Reference ID/Investigator# 51546 Philadelphia Pennsylvania United States 19114
    16 Site Reference ID/Investigator# 50806 San Antonio Texas United States 78229
    17 Site Reference ID/Investigator# 51342 San Antonio Texas United States 78229
    18 Site Reference ID/Investigator# 50811 Sandy Utah United States 84070
    19 Site Reference ID/Investigator# 50902 Norfolk Virginia United States 23507
    20 Site Reference ID/Investigator# 50882 Seattle Washington United States 98105
    21 Site Reference ID/Investigator# 53363 San Juan Puerto Rico 00935
    22 Site Reference ID/Investigator# 53362 Santurce Puerto Rico 00910

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)
    • Neurocrine Biosciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01403038
    Other Study ID Numbers:
    • M12-673
    First Posted:
    Jul 27, 2011
    Last Update Posted:
    Jan 8, 2013
    Last Verified:
    Jan 1, 2013

    Study Results

    No Results Posted as of Jan 8, 2013