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GnRH Antagonist

Elagolix for Unexplained Infertility (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 month 9
Awards & highlights

Summary

This trial is testing whether a new generation GnRHr antagonist is more effective than oral contraceptives for suppressing endometriosis prior to ET.

Eligible Conditions
  • Unexplained Infertility
  • Endometriosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Live birth rate
Secondary outcome measures
Inflammation measurements
Miscarriage rate
Pregnancy rate

Side effects data

From 2021 Phase 4 trial • 82 Patients • NCT03886220
13%
HEADACHE
11%
HOT FLUSH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Elagolix 150 mg

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
~5710

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,922 Total Patients Enrolled
1 Trials studying Unexplained Infertility
University of North Carolina, Chapel HillOTHER
1,526 Previous Clinical Trials
4,197,227 Total Patients Enrolled
Stanford UniversityOTHER
2,411 Previous Clinical Trials
17,462,929 Total Patients Enrolled
1 Trials studying Unexplained Infertility
41 Patients Enrolled for Unexplained Infertility
~3 spots leftby Jul 2025