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Aromatase Inhibitor

Letrozole for Endometriosis Pain Management (APPOSE Trial)

Q: What are the prevailing applications of Letrozole?

<p>Letrozole can be administered to alleviate <a href="https://www.withpower.com/clinical-trials/breast">breast</a> <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, restore ovulatory cycles, and offer relief from the effects of Tamoxifen.</p>

Phase 2

Waitlist Available

Led By Marcelle I Cedars

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Age 18-42 years

Prior diagnosis of endometriosis by one of the following: (1) surgical diagnosis (2) endometrioma on pelvic ultrasound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years.

Awards & highlights

APPOSE Trial Summary

This trial will test whether ovarian hyperstimulation can improve endometriosis symptoms, as well as whether the use of letrozole during ovarian hyperstimulation can improve symptoms, embryo/egg quality and quantity, and pregnancy rates.

Who is the study for?

This trial is for women aged 18-42 with a prior diagnosis of endometriosis who are planning to undergo controlled ovarian hyperstimulation and intend to freeze all retrieved eggs or embryos. It's not suitable for those with significant health issues, psychiatric disorders, or hypersensitivity to letrozole.Check my eligibility

What is being tested?

The study compares the effects of Letrozole versus a placebo on pain during ovarian stimulation in patients with endometriosis. It also examines how Letrozole affects egg/embryo quality and pregnancy rates in a randomized double-blind setup.See study design

What are the potential side effects?

Letrozole may cause side effects such as fatigue, hot flashes, joint pain, and nausea. Since it's being compared to a placebo (a pill without active medication), some participants won't experience these drug-related side effects.

APPOSE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 42 years old.

Select...

I have been diagnosed with endometriosis either through surgery or an ultrasound.

APPOSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole

Secondary outcome measures

Average Delta in Endometriosis Pain Score Pre and Post Stimulation Compared to No Endometriosis

Does Letrozole Impact Embryo and Egg Quantity in Endometriosis

Egg Maturity

+4 more

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

APPOSE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Endometriosis LetrozoleExperimental Treatment1 Intervention

Participants will be asked to take 5mg letrozole daily throughout their ovarian stimulation and for 2 weeks following retrieval. Participants will be blinded to their randomization to letrozole. Participants will be asked to complete surveys during their stimulation and up to 12 weeks following retrieval to evaluate endometriosis associated symptoms. Specifically, surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval. There will be a total of 20 participants in this arm.

Group II: No Endometriosis ControlActive Control1 Intervention

Participants will be asked to complete surveys during their ovarian stimulation and up to 12 weeks following retrieval to evaluate symptoms of pelvic pain. Specifically, surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval. There will be a total of 20 participants in this arm.

Group III: Endometriosis PlaceboPlacebo Group1 Intervention

Participants will be asked to take one tablet placebo daily throughout their ovarian stimulation and for 2 weeks following retrieval. Participants will be blinded to their randomization to placebo. Participants will be asked to complete surveys during their stimulation and up to 12 weeks following retrieval to evaluate endometriosis associated symptoms. Specifically, surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval. There will be a total of 20 participants in this arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,490 Total Patients Enrolled

1 Trials studying Endometriosis

114 Patients Enrolled for Endometriosis

Marcelle I CedarsPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04002141 — Phase 2

Endometriosis Research Study Groups: Endometriosis Placebo, Endometriosis Letrozole, No Endometriosis Control

Endometriosis Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT04002141 — Phase 2

Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002141 — Phase 2

Frequently Asked Questions

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

Is enrollment for this study still underway?

"Affirmative. According to clinicaltrials.gov, the trial opened on September 17th 2019 and has been modified most recently on November 29th 2022. The study is recruiting 60 patients from a single medical centre."

Answered by AI

Are there any qualifications necessary to join this clinical research endeavor?

"This clinical trial is searching for 60 participants, aged between 18 and 42 years old who have received a diagnosis of endometrioma. In addition to these criteria, the team requires that all retrieved oocytes/embryos be frozen prior to transfer. The patient must also plan on undergoing controlled ovarian hyperstimulation and their affliction with endometriosis can either be confirmed surgically or through an ultrasound scan."

Answered by AI

Has Letrozole been officially ratified by the Food and Drug Administration?

"The safety of letrozole was rated a 2, as it is only supported by preliminary clinical data which demonstrates its security but not its efficacy."

Answered by AI

Have prior experiments demonstrated the efficacy of Letrozole?

"As of now, 154 clinical trials are underway investigating the efficacy and safety of Letrozole. 39 of those studies have reached Phase 3 out of a total 10968 trial sites across San Francisco, California."

Answered by AI

What is the aggregate number of individuals participating in this trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this research study has been actively recruiting since September 17th 2019 and was recently updated in November of 2022. This medical investigation needs to enrol 60 individuals at one site for completion."

Answered by AI

What are the prevailing applications of Letrozole?

"Letrozole can be administered to alleviate breast pain, restore ovulatory cycles, and offer relief from the effects of Tamoxifen."

Answered by AI

Is this research initiative open to participants who are younger than 85 years of age?

"For consideration in this medical study, individuals must be aged 18 to 42. Those under eighteen can apply for one of the 8 trials targeted toward minors and persons over sixty-five have access to 148 clinical studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis

2019. "Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002141.

All > Endometriosis