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

This study has been completed.
Sponsor:
Collaborator:
Neurocrine Biosciences
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01403038
First received: June 1, 2011
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Folliculogenesis
Drug: Elagolix
Drug: elagolix
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Ovulation Classification [ Time Frame: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    As measured by the Hoogland and Skouby 6-point ovarian activity grading system


Secondary Outcome Measures:
  • Endocrine Parameters [ Time Frame: During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Inhibin-B and Antimullerian hormone

  • Adverse events [ Time Frame: All adverse events occurring through the Final Visit will be reported ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Chemistry, hematology, urinalysis

  • 12-lead Electrocardiogram [ Time Frame: Change from baseline to Week 4 and Final Visit ] [ Designated as safety issue: Yes ]
    12-lead Electrocardiogram

  • Vital Signs [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, temperature


Enrollment: 216
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elagolix Dose Regimen 1
Elagolix Dose regimen 1 for 84 days
Drug: Elagolix
Elagolix Dose Regimen 1 for 84 days
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: ABT-620, elagolix sodium

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403038

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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01403038     History of Changes
Other Study ID Numbers: M12-673
Study First Received: June 1, 2011
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
healthy volunteers
elagolix
endometriosis
ovarian reserve
gonadotropin-releasing hormone antagonist
ovulation
ovarian activity

ClinicalTrials.gov processed this record on July 29, 2014