An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
- Registration Number
- NCT01403038
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 216
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elagolix Dose Regimen 1 elagolix Elagolix Dose regimen 1 for 84 days Elagolix Dose Regimen 2 elagolix Elagolix Dose Regimen 2 for 84 days Elagolix Dose Regimen 3 elagolix Elagolix Dose Regimen 3 for 84 days Elagolix Dose Regimen 4 elagolix Elagolix Dose Regimen 4 for 84 days Additional Dose Regimens may be added and will be administered for 84 days. Elagolix Dose Regimen 6 elagolix Elagolix Dose Regimen 6 for 84 days Elagolix Dose Regimen 7 elagolix Elagolix Dose Regimen 7 for 84 days Elagolix Dose Regimen 5 elagolix Elagolix Dose Regimen 5 for 84 days
- Primary Outcome Measures
Name Time Method 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
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
Name Time Method 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
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
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.
Clinical Laboratory Tests Change from baseline to Cycles 1, 2, and 3 or Final Visit Chemistry, hematology, urinalysis
12-lead Electrocardiogram Change from baseline to Week 4 and Final Visit 12-lead Electrocardiogram
Vital Signs Change from baseline to Cycles 1, 2, and 3 or Final Visit Blood pressure, heart rate, temperature
Trial Locations
- Locations (22)
Site Reference ID/Investigator# 50805
🇺🇸Colorado Springs, Colorado, United States
Site Reference ID/Investigator# 51270
🇺🇸Colorado Springs, Colorado, United States
Site Reference ID/Investigator# 50884
🇺🇸Denver, Colorado, United States
Site Reference ID/Investigator# 50404
🇺🇸Lonetree, Colorado, United States
Site Reference ID/Investigator# 50904
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 50808
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 50402
🇺🇸South Miami, Florida, United States
Site Reference ID/Investigator# 50807
🇺🇸Naperville, Illinois, United States
Site Reference ID/Investigator# 50804
🇺🇸Oak Brook, Illinois, United States
Site Reference ID/Investigator# 50803
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 51546
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 53363
🇵🇷San Juan, Puerto Rico
Site Reference ID/Investigator# 50902
🇺🇸Norfolk, Virginia, United States
Site Reference ID/Investigator# 51342
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 50882
🇺🇸Seattle, Washington, United States
Site Reference ID/Investigator# 50811
🇺🇸Sandy, Utah, United States
Site Reference ID/Investigator# 53362
🇵🇷Santurce, Puerto Rico
Site Reference ID/Investigator# 50806
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 50762
🇺🇸Durham, North Carolina, United States
Site Reference ID/Investigator# 50403
🇺🇸Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 50883
🇺🇸Portland, Oregon, United States
Site Reference ID/Investigator# 50810
🇺🇸Cincinnati, Ohio, United States