Folliculogenesis Clinical Trial
Official title:
A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females
| Verified date | January 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 216 |
| Est. completion date | November 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Site Reference ID/Investigator# 53363 | San Juan | |
| Puerto Rico | Site Reference ID/Investigator# 53362 | Santurce | |
| United States | Site Reference ID/Investigator# 50810 | Cincinnati | Ohio |
| United States | 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# 50762 | Durham | North Carolina |
| United States | Site Reference ID/Investigator# 50404 | Lonetree | Colorado |
| United States | Site Reference ID/Investigator# 50904 | Miami | Florida |
| United States | Site Reference ID/Investigator# 50807 | Naperville | Illinois |
| United States | Site Reference ID/Investigator# 50902 | Norfolk | Virginia |
| 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# 50883 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 50806 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 51342 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 50811 | Sandy | Utah |
| United States | Site Reference ID/Investigator# 50882 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 50402 | South Miami | Florida |
| United States | Site Reference ID/Investigator# 50808 | Tampa | Florida |
| United States | Site Reference ID/Investigator# 50403 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) | Neurocrine Biosciences |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ovulation Classification | Presence or absence of ovulation | During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. | No |
| Primary | Ovarian Activity | As measured by the Hoogland and Skouby 6-point ovarian activity grading system | During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. | No |
| Secondary | Endocrine Parameters | Estuarial, Progesterone, luteinizing hormone, follicle stimulating hormone | During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3 | No |
| Secondary | Ovarian Reserve | Inhibin-B and Antimullerian hormone | During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3. | No |
| Secondary | Adverse events | All adverse events will be collected by subject self-report and review of laboratory parameters, physical exam. vital sign measurements and electrocardiograms. | All adverse events occurring through the Final Visit will be reported | Yes |
| Secondary | Clinical Laboratory Tests | Chemistry, hematology, urinalysis | Change from baseline to Cycles 1, 2, and 3 or Final Visit | Yes |
| Secondary | 12-lead Electrocardiogram | 12-lead Electrocardiogram | Change from baseline to Week 4 and Final Visit | Yes |
| Secondary | Vital Signs | Blood pressure, heart rate, temperature | Change from baseline to Cycles 1, 2, and 3 or Final Visit | Yes |