Folliculogenesis
Conditions
Keywords
healthy volunteers, elagolix, endometriosis, ovarian reserve, gonadotropin-releasing hormone antagonist, ovulation, ovarian activity
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.
Interventions
DRUGElagolix
Elagolix Dose Regimen 1 for 84 days
DRUGelagolix
Elagolix plus Activella Dose Regimen 7 for 84 days
Sponsors
Neurocrine Biosciences
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Vital Signs | Change from baseline to Cycles 1, 2, and 3 or Final Visit | Blood pressure, heart rate, temperature |
| 12-lead Electrocardiogram | Change from baseline to Week 4 and Final Visit | 12-lead Electrocardiogram |
| 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 |
Countries
Puerto Rico, United States
Outcome results
None listed