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

NCT ID: NCT01403038

Last Updated: 2013-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

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Detailed Description

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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.

Conditions

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Folliculogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Elagolix Dose Regimen 1

Elagolix Dose regimen 1 for 84 days

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix Dose Regimen 1 for 84 days

Elagolix Dose Regimen 2

Elagolix Dose Regimen 2 for 84 days

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix Dose Regimen 2 for 84 days

Elagolix Dose Regimen 3

Elagolix Dose Regimen 3 for 84 days

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix Dose Regimen 3 for 84 days

Elagolix Dose Regimen 4

Elagolix Dose Regimen 4 for 84 days

Additional Dose Regimens may be added and will be administered for 84 days.

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix Dose Regimen 4 for 84 days Other interventions may be added

Elagolix Dose Regimen 5

Elagolix Dose Regimen 5 for 84 days

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix Dose Regimen 5 for 84 days

Elagolix Dose Regimen 6

Elagolix Dose Regimen 6 for 84 days

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix Dose Regimen 6 for 84 days

Elagolix Dose Regimen 7

Elagolix Dose Regimen 7 for 84 days

Group Type EXPERIMENTAL

elagolix

Intervention Type DRUG

Elagolix plus Activella Dose Regimen 7 for 84 days

Interventions

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Elagolix

Elagolix Dose Regimen 1 for 84 days

Intervention Type DRUG

Elagolix

Elagolix Dose Regimen 2 for 84 days

Intervention Type DRUG

Elagolix

Elagolix Dose Regimen 3 for 84 days

Intervention Type DRUG

Elagolix

Elagolix Dose Regimen 4 for 84 days Other interventions may be added

Intervention Type DRUG

Elagolix

Elagolix Dose Regimen 5 for 84 days

Intervention Type DRUG

Elagolix

Elagolix Dose Regimen 6 for 84 days

Intervention Type DRUG

elagolix

Elagolix plus Activella Dose Regimen 7 for 84 days

Intervention Type DRUG

Other Intervention Names

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ABT-620, elagolix sodium ABT-620, elagolix sodium ABT-620, elagolix sodium ABT-620, elagolix sodium ABT-620, elagolix sodium ABT-620, elagolix sodium ABT-620, elagolix sodium

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Neurocrine Biosciences

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristof Chwalisz, MD, PhD, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 50805

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 51270

Colorado Springs, Colorado, United States

Site Status

Site Reference ID/Investigator# 50884

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 50404

Lonetree, Colorado, United States

Site Status

Site Reference ID/Investigator# 50904

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 50402

South Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 50808

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 50807

Naperville, Illinois, United States

Site Status

Site Reference ID/Investigator# 50804

Oak Brook, Illinois, United States

Site Status

Site Reference ID/Investigator# 50762

Durham, North Carolina, United States

Site Status

Site Reference ID/Investigator# 50403

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 50810

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 50883

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 50803

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 51546

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 50806

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 51342

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 50811

Sandy City, Utah, United States

Site Status

Site Reference ID/Investigator# 50902

Norfolk, Virginia, United States

Site Status

Site Reference ID/Investigator# 50882

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 53363

San Juan, , Puerto Rico

Site Status

Site Reference ID/Investigator# 53362

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Archer DF, Ng J, Chwalisz K, Chiu YL, Feinberg EC, Miller CE, Feldman RA, Klein CE. Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz086. doi: 10.1210/clinem/dgz086.

Reference Type DERIVED
PMID: 31650182 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29476499 (View on PubMed)

Other Identifiers

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M12-673

Identifier Type: -

Identifier Source: org_study_id

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