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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) )

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.

Condition or disease Intervention/treatment Phase
Folliculogenesis Drug: Elagolix Drug: elagolix Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

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 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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  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.

  4. Clinical Laboratory Tests [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ]
    Chemistry, hematology, urinalysis

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

  6. Vital Signs [ Time Frame: Change from baseline to Cycles 1, 2, and 3 or Final Visit ]
    Blood pressure, heart rate, temperature



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403038


Locations
Show Show 22 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Neurocrine Biosciences
Investigators
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Study Director: Kristof Chwalisz, MD, PhD, MD AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01403038    
Other Study ID Numbers: M12-673
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
healthy volunteers
elagolix
endometriosis
ovarian reserve
gonadotropin-releasing hormone antagonist
ovulation
ovarian activity