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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403038
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : January 8, 2013
Sponsor:
Collaborator:
Neurocrine Biosciences
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE June 1, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date January 8, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01403038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
  • 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
  • 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
  • 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.
  • Clinical Laboratory Tests [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ]
    Chemistry, hematology, urinalysis
  • 12-lead Electrocardiogram [ Time Frame: Change from baseline to Week 4 and Final Visit ]
    12-lead Electrocardiogram
  • Vital Signs [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ]
    Blood pressure, heart rate, temperature
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • Endocrine Parameters [ Time Frame: During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3 ]
    Estradiol, Progesterone, luteininzing hormone, follicle stimulating hormone
  • 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
  • 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.
  • Clinical Laboratory Tests [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ]
    Chemistry, hematology, urinalysis
  • 12-lead Electrocardiogram [ Time Frame: Change from baseline to Week 4 and Final Visit ]
    12-lead Electrocardiogram
  • Vital Signs [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ]
    Blood pressure, heart rate, temperature
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
Official Title  ICMJE A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Folliculogenesis
Intervention  ICMJE
  • Drug: Elagolix
    Elagolix Dose Regimen 1 for 84 days
    Other Name: ABT-620, elagolix sodium
  • Drug: Elagolix
    Elagolix Dose Regimen 2 for 84 days
    Other Name: ABT-620, elagolix sodium
  • Drug: Elagolix
    Elagolix Dose Regimen 3 for 84 days
    Other Name: ABT-620, elagolix sodium
  • Drug: Elagolix
    Elagolix Dose Regimen 4 for 84 days Other interventions may be added
    Other Name: ABT-620, elagolix sodium
  • Drug: Elagolix
    Elagolix Dose Regimen 5 for 84 days
    Other Name: ABT-620, elagolix sodium
  • Drug: Elagolix
    Elagolix Dose Regimen 6 for 84 days
    Other Name: ABT-620, elagolix sodium
  • Drug: elagolix
    Elagolix plus Activella Dose Regimen 7 for 84 days
    Other Name: ABT-620, elagolix sodium
Study Arms  ICMJE
  • Experimental: Elagolix Dose Regimen 1
    Elagolix Dose regimen 1 for 84 days
    Intervention: Drug: Elagolix
  • Experimental: Elagolix Dose Regimen 2
    Elagolix Dose Regimen 2 for 84 days
    Intervention: Drug: Elagolix
  • Experimental: Elagolix Dose Regimen 3
    Elagolix Dose Regimen 3 for 84 days
    Intervention: Drug: Elagolix
  • 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.

    Intervention: Drug: Elagolix
  • Experimental: Elagolix Dose Regimen 5
    Elagolix Dose Regimen 5 for 84 days
    Intervention: Drug: Elagolix
  • Experimental: Elagolix Dose Regimen 6
    Elagolix Dose Regimen 6 for 84 days
    Intervention: Drug: Elagolix
  • Experimental: Elagolix Dose Regimen 7
    Elagolix Dose Regimen 7 for 84 days
    Intervention: Drug: elagolix
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2013)
216
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
200
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403038
Other Study ID Numbers  ICMJE M12-673
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Neurocrine Biosciences
Investigators  ICMJE
Study Director: Kristof Chwalisz, MD, PhD, MD AbbVie
PRS Account AbbVie
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP