Elagolix for Endometriosis

(EFFECT Trial)

Overseen By Dan Angress

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must be taking: GnRHr agonists, OCPs

Disqualifiers: Diabetes, Hypothyroidism, Hyperprolactinemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called elagolix (also known as Orilissa or Oriahnn) to determine if it can improve pregnancy rates for women with suspected endometriosis undergoing IVF. Endometriosis can reduce pregnancy chances, so the trial compares elagolix with regular birth control pills to identify which is more effective. Women who have tried IVF, have at least one healthy embryo ready for transfer, and have been told they might have endometriosis could be suitable candidates. The trial will measure the number of participants who become pregnant, experience miscarriages, and have successful births. As a Phase 2 trial, this research focuses on assessing elagolix's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves specific treatments for endometriosis, it's best to discuss your current medications with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that elagolix, a treatment being tested for fertility, has also been studied for other health issues. In past studies, serious side effects were uncommon. For instance, only 0.8% of women taking a similar medication, ORIAHNN, experienced serious problems like heavy menstrual bleeding. Some serious side effects of elagolix in similar studies included appendicitis (0.3%), stomach pain (0.2%), and back pain (0.2%).

Although these numbers are low, elagolix can increase the risk of heart issues, such as heart attacks or blood clots. These studies suggest that most patients generally tolerate elagolix well, but awareness of these possible risks is crucial. Always consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Elagolix because it offers a novel approach to enhancing fertility. Unlike standard treatments involving estrogen-containing birth control pills used before IVF or embryo transfer, Elagolix is a non-estrogen oral medication that targets the gonadotropin-releasing hormone (GnRH) receptors. This mechanism reduces hormone levels that can interfere with fertility, potentially optimizing conditions for pregnancy. Additionally, Elagolix is administered at a higher dose than in previous trials for pelvic pain, which may provide more pronounced effects on fertility enhancement.

What evidence suggests that this trial's treatments could be effective for improving pregnancy rates following embryo transfer?

This trial will compare the effectiveness of elagolix with oral contraceptives in improving pregnancy chances for women with suspected endometriosis undergoing IVF-ET (in vitro fertilization and embryo transfer). Research has shown that endometriosis can lower pregnancy rates after embryo transfer. Early studies on elagolix suggest it might help by reducing the effects of endometriosis. However, some studies found no significant difference in pregnancy outcomes compared to other treatments. The trial aims to determine if elagolix can work better than standard treatments like birth control pills in this situation. More data is needed to confirm its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Bruce A Lessey, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Inclusion Criteria

At least 1 euploid embryo for transfer

Endometrial thickness > 5.9 and < 14 mm

Anti-Mullerian Hormone (AMH) > 0.5 and < 10

Exclusion Criteria

You have not received treatment for an underactive thyroid.

Uterine fibroids > 4 cm (intramural)

Positive lupus anticoagulant or positive anti-cardiolipin antibody testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elagolix or oral contraceptives for suppression of suspected endometriosis prior to embryo transfer

8 weeks

Regular visits for monitoring and medication administration

Frozen Embryo Transfer (FET)

Participants undergo frozen embryo transfer of a single euploid embryo

1 week

1 visit for embryo transfer procedure

Follow-up

Participants are monitored for pregnancy outcomes, including miscarriage and live birth rates

15 weeks

Follow-up visits to assess pregnancy outcomes

What Are the Treatments Tested in This Trial?

Interventions

• Elagolix
• Oral Contraceptive

How Is the Trial Designed?

Group I: Elagolix Experimental Treatment 1 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 Control 1 Intervention

Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills.

Elagolix is already approved in United States for the following indications:

Approved in United States as Orilissa for:

• Management of moderate to severe pain associated with endometriosis

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04039204

Study Details | NCT04039204 | Elagolix for Fertility ... Studies suggest that undiagnosed endometriosis results in poor reproductive outcomes in the setting of In Vitro Fertilization and Embryo Transfer (IVF-ET).

2. fertstertreports.org fertstertreports.org/article/S2666-3341(24)00120-X/fulltext

Elagolix for ovulation suppression in in vitro fertilization The findings demonstrated that elagolix showed no significant difference in embryological and clinical outcomes when compared with G/C. However, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207753/

Pre-IVF treatment with a GnRH antagonist in women with ... Most women using elagolix menstruate in the first 2 months with only a 50% amenorrhoea rate after 1 year in the phase III clinical trial, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06375811

Pre-IVF Treatment With a GnRH Antagonist in Women ... A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666334124000771

The role of elagolix in ovulation suppression during ... The primary outcomes were cycle cancellation, biochemical pregnancy, and sustained implantation rates, whereas the secondary outcomes were miscarriage, ...

6. oriahnnhcp.com oriahnnhcp.com/safety-adverse-reactions

ORIAHNN® Safety Profile & Adverse Reactions Serious adverse events were reported in 3 (0.8%) women taking ORIAHNN in ELARIS UF-1 and UF-2. Two women had heavy menstrual bleeding and required blood ...

7. orilissa.com orilissa.com/hcp/clinical-data/safety-information-and-tolerability

Safety and Tolerability Profile of ORILISSA® (elagolix) The most common serious adverse events reported with ORILISSA in ELARIS EM-1 and EM-2 included appendicitis (0.3%), abdominal pain (0.2%), and back pain (0.2%).

8. oriahnn.com oriahnn.com/side-effects-and-safety-considerations

ORIAHNN® Side Effects and Safety Considerations ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) may increase your chances of heart attack, stroke, or blood clots, ...

9. orilissa.com orilissa.com/about/side-effects-and-safety-considerations

Understanding Side Effects The most common serious adverse events reported in the clinical studies included appendicitis (0.3%), abdominal pain (0.2%), and back pain (0.2%). For more ...

10. rxabbvie.com rxabbvie.com/pdf/oriahnn_pi.pdf

Oriahnn-uspi-elagolix-estradiol-and-norethindrone-acetate ORIAHNN may delay the ability to recognize the occurrence of a pregnancy because it may reduce the intensity, duration, and amount of menstrual bleeding [see ...