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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 1 year
Awards & highlights

EFFECT Trial 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

EFFECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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
Number of amniotic sacs
Number of subjects with categorical outcome of biochemical pregnancy
+3 more
Secondary outcome measures
Miscarriage 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

EFFECT 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
1,240 Previous Clinical Trials
1,004,197 Total Patients Enrolled
1 Trials studying Unexplained Infertility
University of North Carolina, Chapel HillOTHER
1,504 Previous Clinical Trials
4,187,652 Total Patients Enrolled
Stanford UniversityOTHER
2,386 Previous Clinical Trials
17,333,998 Total Patients Enrolled
1 Trials studying Unexplained Infertility
41 Patients Enrolled for Unexplained Infertility

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been admitted to this clinical experiment thus far?

"Indeed, clinicaltrials.gov attests that this medical experiment is actively recruiting participants. This study was initially published on the 15th of January 2022 and last updated on December 1st, with a quota of 100 enrollees at one center."

Answered by AI

What health conditions is Elagolix typically employed to address?

"Elagolix is an excellent choice for treating mild to moderate acne; it can also prove beneficial in managing polycystic ovary syndrome, premenstrual dysphoric disorder, and severe menopausal vulvovaginal atrophy."

Answered by AI

Who is authorized to participate in this clinical investigation?

"A total of 100 individuals with endometrioma, aged between 18 and 42, have been accepted into the trial. Admission is only possible if they meet two conditions: their Anti-Mullerian Hormone (AMH) must be greater than 0.5 and less than 10, as well as having at least one euploid embryo for transfer."

Answered by AI

Are applicants aged 45 or younger accepted for participation in this research?

"To be included in this study, patients must fall within the 18-42 age bracket. For those younger than 18 and older than 65, there are 23 trials and 49 studies available respectively."

Answered by AI

Are there still openings for participants in this research investigation?

"Affirmative. Clinicaltrials.gov states that the research study, which was inaugurated on January 15th 2022 is currently welcoming applicants. The clinical trial necessitates 100 individuals from a single centre to partake in it."

Answered by AI

What risks might be associated with utilizing Elagolix?

"Given that it is a Phase 2 trial, with clinical data supporting safety but none for efficacy, Elagolix was assigned a score of two."

Answered by AI

What research has previously been conducted involving Elagolix?

"At the moment, 19 trials are in effect to study Elagolix. Out of these investigations, 6 are situated at Phase 3 and have been established around Chicago, Illinois; however, there exist 608 sites conducting research on this medication across the country."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Utah
How old are they?
18 - 65
What site did they apply to?
Wake Forest Univesity Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~3 spots leftby Apr 2025