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Gonadotropin-releasing hormone (GnRH) antagonist

Elagolix vs Leuprolide for Endometriosis and Infertility

Q: Are there any available vacancies in this experiment for participants?

According to clinicaltrials.gov, the search for participants is ongoing and has been since September 1st 2020 when this trial was first posted. Updates were last made on July 20th 2022.

Q: Does the age-range criterion for this research extend beyond octogenarians?

This trial has established age limitations of 21 to 42 years, thus excluding below-age and elderly participants.

Q: What precedent exists for employing laboratory analyses in other clinical investigations?

Currently, 70 studies related to Lab work are ongoing. Out of these investigations, 28 have been assigned Phase 3 status. The majority of the experiments for Lab work take place in Duarte <a href="https://www.withpower.com/clinical-trials/california">California</a>; however there are 5950 sites conducting clinical trials on this topic globally.

Q: What is the total participant count for this research endeavor?

Affirmative. Clinicaltrials.gov has documented that this medical trial, initially published on September 1st 2020 and most recently updated July 20th 2022, is actively enrolling patients. A total of 30 individuals are being sought from a single site.

Q: How is laboratory testing commonly employed?

Lab work can be utilized to combat menorrhagia, <a href="https://www.withpower.com/clinical-trials/advanced-prostate-cancer">advanced prostate cancer</a>, and the reoccurrence of symptoms.

Q: What criteria are necessary for potential participants to be eligible for this clinical trial?

This clinical trial is looking to enroll 30 individuals with endometrioma that are between 21 and 42 years of age. Prospective participants must have not used GnRH agonist or antagonist for more than a month, nor any treatment for <a href="https://www.withpower.com/clinical-trials/endometriosis">endometriosis</a> in the last four months prior to enrolment. Additionally, applicants should possess at least one euploid embryo available for transfer.

Phase < 1

Waitlist Available

Led By Eric Surrey, MD

Research Sponsored by Colorado Center for Reproductive Medicine

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 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)

Awards & highlights

Study Summary

This trial is testing whether a drug called Elagolix can improve implantation rates in patients with endometriosis who are undergoing IVF.

Who is the study for?

This trial is for women aged 21-42 with surgically confirmed endometriosis, regular menstrual cycles, and at least one embryo ready for IVF transfer. Participants must not have used certain endometriosis treatments recently, agree to use barrier contraception, and have a normal uterine cavity. Women with untreated hydrosalpinx or who've had prolonged GnRH treatments are excluded.Check my eligibility

What is being tested?

The study compares the effectiveness of Elagolix versus Leuprolide Acetate in preparing patients with endometriosis for frozen embryo transfers. One group will take Elagolix daily for two months; the other receives Leuprolide injections every four weeks twice before starting embryo transfer prep.See study design

What are the potential side effects?

Elagolix may cause hot flashes, headache, fatigue, insomnia, mood changes, bone loss and change in menstrual bleeding patterns. Leuprolide can lead to similar effects like hot flashes and mood swings but also includes potential risks such as decreased bone density and changes in reproductive hormone levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of Implantation Rates

Secondary outcome measures

Comparison of Biochemical pregnancy rates

Comparison of hormone levels between the two groups

Comparison of live birth rates and pregnancy loss rates

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test groupExperimental Treatment2 Interventions

Subjects will receive the medication elagolix

Group II: Control groupActive Control2 Interventions

Subjects will receive leuprolide acetate

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Colorado Center for Reproductive MedicineLead Sponsor

5 Previous Clinical Trials

620 Total Patients Enrolled

1 Trials studying Endometriosis

37 Patients Enrolled for Endometriosis

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,354 Total Patients Enrolled

14 Trials studying Endometriosis

5,119 Patients Enrolled for Endometriosis

Eric Surrey, MD4.331 ReviewsPrincipal Investigator - Colorado Center for Reproductive Medicine

Colorado Center for Reproductive Medicine

5Patient Review

Dr. Surrey is an excellent physician who is both knowledgeable and kind. He is also very thorough in his explanations and I would highly recommend him to anyone.

Media Library

Elagolix (Gonadotropin-releasing hormone (GnRH) antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04445025 — Phase < 1

Endometriosis Research Study Groups: Control group, Test group

Endometriosis Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT04445025 — Phase < 1

Elagolix (Gonadotropin-releasing hormone (GnRH) antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04445025 — Phase < 1

Frequently Asked Questions

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

Are there any available vacancies in this experiment for participants?

"According to clinicaltrials.gov, the search for participants is ongoing and has been since September 1st 2020 when this trial was first posted. Updates were last made on July 20th 2022."

Answered by AI

Does the age-range criterion for this research extend beyond octogenarians?

"This trial has established age limitations of 21 to 42 years, thus excluding below-age and elderly participants."

Answered by AI

What precedent exists for employing laboratory analyses in other clinical investigations?

"Currently, 70 studies related to Lab work are ongoing. Out of these investigations, 28 have been assigned Phase 3 status. The majority of the experiments for Lab work take place in Duarte California; however there are 5950 sites conducting clinical trials on this topic globally."

Answered by AI

What is the total participant count for this research endeavor?

"Affirmative. Clinicaltrials.gov has documented that this medical trial, initially published on September 1st 2020 and most recently updated July 20th 2022, is actively enrolling patients. A total of 30 individuals are being sought from a single site."

Answered by AI

How is laboratory testing commonly employed?

"Lab work can be utilized to combat menorrhagia, advanced prostate cancer, and the reoccurrence of symptoms."

Answered by AI

What criteria are necessary for potential participants to be eligible for this clinical trial?

"This clinical trial is looking to enroll 30 individuals with endometrioma that are between 21 and 42 years of age. Prospective participants must have not used GnRH agonist or antagonist for more than a month, nor any treatment for endometriosis in the last four months prior to enrolment. Additionally, applicants should possess at least one euploid embryo available for transfer."

Answered by AI