GnRH Antagonist

Elagolix 200 MG for Infertility

UNC Fertility, Raleigh, NC

Targeting 2 different conditionsElagolix 200 MG +1 morePhase 3RecruitingLed by Hugh Taylor, MDResearch Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women who plan to undergo IVF for treatment of infertility

Be between 18 and 65 years old

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 15 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Study Summary

This trial will test if a GnRH antagonist can improve live birth rates in infertile women with endometriosis undergoing IVF.

Eligible Conditions

Infertility
Endometriosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You are a woman who is planning to have in vitro fertilization (IVF) to help with infertility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months 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

Biochemical pregnancy rate

Clinical pregnancy rate

Fertilization rate

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pre-IVF Treatment with 60 day course of Placebo or SOC IVFExperimental Treatment1 Intervention

For those who agree to be randomized, subjects will be randomized to placebo, BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who want to continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.

Group II: Pre-IVF Treatment with 60 day course of oral GnRH antagonistActive Control1 Intervention

For those who agree to be randomized, subjects will be randomized to elagolix 200mg BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who do not want to be randomized while choose elagolix.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,760 Previous Clinical Trials

2,689,096 Total Patients Enrolled

14 Trials studying Infertility

95,963 Patients Enrolled for Infertility

Northwestern UniversityOTHER

1,525 Previous Clinical Trials

911,790 Total Patients Enrolled

5 Trials studying Infertility

1,910 Patients Enrolled for Infertility

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,894 Previous Clinical Trials

2,195,854 Total Patients Enrolled

32 Trials studying Infertility

16,824 Patients Enrolled for Infertility

University of Colorado, DenverOTHER

1,661 Previous Clinical Trials

1,661,254 Total Patients Enrolled

9 Trials studying Infertility

29,635 Patients Enrolled for Infertility

University of North CarolinaOTHER

160 Previous Clinical Trials

1,436,629 Total Patients Enrolled

3 Trials studying Infertility

582 Patients Enrolled for Infertility

Jared Robbins, MDStudy Director

Northwestern University

Esther Eisenberg, MDStudy Director

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

3 Previous Clinical Trials

242 Total Patients Enrolled

2 Trials studying Infertility

203 Patients Enrolled for Infertility

David Weinberg, PhDStudy Director

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1 Previous Clinical Trials

200 Total Patients Enrolled

1 Trials studying Infertility

200 Patients Enrolled for Infertility

Hugh Taylor, MDPrincipal Investigator

Yale University

2 Previous Clinical Trials

69 Total Patients Enrolled

Heping Zhang, PhDStudy Director

Yale University

11 Previous Clinical Trials

4,547 Total Patients Enrolled

7 Trials studying Infertility

3,389 Patients Enrolled for Infertility

Nanette Santoro, MDStudy Director

University of Colorado, Denver

15 Previous Clinical Trials

5,554 Total Patients Enrolled

10 Trials studying Infertility

4,334 Patients Enrolled for Infertility

Emily Jungheim, MDStudy Director

Northwestern University

Abisola Tepede, PharmDStudy Director

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Steven Young, MD, PhDStudy Director

Duke University

Media Library

Elagolix (GnRH Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04173169 — Phase 3

Infertility Research Study Groups: Pre-IVF Treatment with 60 day course of oral GnRH antagonist, Pre-IVF Treatment with 60 day course of Placebo or SOC IVF

Infertility Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT04173169 — Phase 3

Elagolix (GnRH Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173169 — Phase 3

Infertility Patient Testimony for trial: Trial Name: NCT04173169 — Phase 3

Frequently Asked Questions

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

How many different medical facilities are overseeing this clinical trial today?

"Presently, this trial is enrolling patients at 6 sites. The sites are located in Baltimore, Aurora and Raleigh as well as 6 other locations. If you enroll, selecting the location nearest to you will help to minimize travel demands."

Answered by AI

How many people does this research project include?

"That is correct, the listing on clinicaltrials.gov confirms that the research team is currently enrolling patients. The study, which was first advertised on March 15th, requires 814 individuals from 6 different locations."

Answered by AI

What have doctors most commonly prescribed Elagolix 200 MG for?

"Elagolix 200 MG is an effective treatment for menorrhagia, ovulation induction therapy, and fibroid tumors."

Answered by AI

Are there other examples of Elagolix 200 MG being put to clinical use?

"There are currently 55 clinical studies investigating Elagolix 200 MG, with 15 of them being in Phase 3. Many of the Phase 3 trials are based in Chicago, Illinois, but there are a total of 1922 locations running clinical trials for Elagolix 200 MG."

Answered by AI

Would this experiment be appropriate for an elderly subject?

"According to the eligibility criteria for this clinical trial, patients must be between 18-40 years old. If the patient is not qualified for this trial, there are 23 other clinical trials that they could potentially participate in. If the patient is over 65, there are 72 other clinical trials."

Answered by AI

Has Elagolix 200 MG received FDA approval?

"Elagolix 200 MG is Phase 3, so it has some clinical data to support its efficacy and multiple rounds of data supporting its safety--our team rates it a 3."

Answered by AI

Could I potentially join this medical study?

"This clinical trial is looking for 814 participants that currently suffer from infertility. The ideal candidate should be between the ages of 18-40 and meet the following requirements: Be willing to comply with trial procedures, including reporting of obstetrical outcomes after delivery, have the intention of undergoing IVF treatment for infertility, have a documented diagnosis of endometriosis, have a BMI of 18-40 kg/m2, have an AMH of >= 0.5ng/ml, have no known uterine cavity abnormalities, have one ovary with no clinically significant abnormalities, and have negative results for gonorrhea and chlamydia."

Answered by AI

Who else is applying?

What state do they live in?

Illinois

Indiana

Connecticut

Other

How old are they?

18 - 65

What site did they apply to?

Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences

Other

University of Colorado Department of Obstetrics & Gynecology

Northwestern University Department of Obstetrics and Gynecology

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

We have tried 6 rounds of letrozole. My first egg retrieval I only got 1 egg, even with Stims. I have waited my entire life to be a mother and I dream of making this happen.

Patient