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GnRH Antagonist

Elagolix for Endometriosis (PREGnant Trial)

Phase 3

Recruiting

Led By Hugh Taylor, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Age ≥18 and <40 years at time of egg retrieval or signing informed consent

Documentation of diagnosis of endometriosis by surgical visualization of endometriosis (laparoscopy or laparotomy) or diagnosis by pathology within the last 10 years before the initial trial entry visit or documentation of ovarian endometrioma >2 cm or two or more smaller endometriomas that total >2 cm in diameter. If entry is based on the presence of an endometrioma, transvaginal ultrasound evaluation must document the same unambiguous endometrioma on two separate occasions in more than one menstrual cycle. Images will be printed or transmitted electronically and read centrally by investigators at Yale to assure uniform diagnostic criteria (classic ground glass appearance) are applied

Must not have

Presence of hydrosalpinx measuring >2cm on ultrasound, untreated endometrial polyps or intrauterine adhesions

Patients with cirrhosis or abnormal LFTs per self report or documented in the electronic medical record (EMR)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication given by mouth to women with endometriosis who are trying to get pregnant through IVF. The main goal is to see if the medication can increase the chances

Who is the study for?

This trial is for women with endometriosis who are struggling to get pregnant and planning to undergo IVF. Participants should not have received any hormonal treatments within the last three months.

What is being tested?

The study tests if taking a GnRH antagonist called Elagolix before starting IVF can increase the chances of giving birth. Women in the trial will either receive Elagolix or a placebo (a pill without active medication).

What are the potential side effects?

Elagolix may cause side effects like headache, nausea, insomnia, anxiety, reduced bone density, hot flashes, mood changes, and menstrual irregularities.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 40 years old.

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My endometriosis was confirmed by surgery or pathology within the last 10 years, or I have an ovarian cyst linked to endometriosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a fluid-filled fallopian tube or untreated growths in my uterus.

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I have cirrhosis or abnormal liver function tests.

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I am scheduled for surgery related to endometriosis or in the abdominal area during the trial.

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I have been pregnant in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Live birth rate

Secondary study objectives

Biochemical pregnancy rate

Clinical pregnancy rate

Fertilization rate

+6 more

Awards & Highlights

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 the participants 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 / 6Eligibility criteria met