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GnRH Antagonist
Elagolix for Fertility Enhancement Clinical Trial (EFFECT Trial)
Phase 2
Waitlist Available
Led By Bruce A Lessey, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 15
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing a new medication called elagolix to birth control pills in women who have had unsuccessful IVF treatments and may have undiagnosed endometriosis. Elagolix helps by blocking hormones that can make endometriosis worse, which might improve pregnancy rates.
Eligible Conditions
- Unexplained Infertility
- Endometriosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 15
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Miscarriages
Other study objectives
Inflammation Measurements
Side effects data
From 2021 Phase 4 trial • 82 Patients • NCT0388622013%
HEADACHE
11%
HOT FLUSH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Elagolix 150 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ElagolixExperimental Treatment1 Intervention
Elagolix will be dosed at the higher dose used in pelvic pain trials, 200 mg twice a day for 2 months.
Group II: Oral contraceptives (Ortho Cyclen)Active Control1 Intervention
Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elagolix
2019
Completed Phase 4
~6190
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,925 Total Patients Enrolled
1 Trials studying Unexplained Infertility
University of North Carolina, Chapel HillOTHER
1,569 Previous Clinical Trials
4,319,574 Total Patients Enrolled
Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,519,202 Total Patients Enrolled
1 Trials studying Unexplained Infertility
41 Patients Enrolled for Unexplained Infertility
Bruce A Lessey, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
82 Total Patients Enrolled
1 Trials studying Unexplained Infertility