Letrozole for Endometriosis Pain Management

(APPOSE Trial)

Overseen By Marcelle I Cedars, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests letrozole in women with endometriosis to see if it can improve their symptoms and egg quality. Letrozole works by lowering estrogen levels, potentially helping with symptom management. Letrozole has been used for a long time in various infertility treatments.

Research Team

Marcelle I Cedars

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 42 years old.

You are planning to undergo a medical procedure called controlled ovarian hyperstimulation.

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

Exclusion Criteria

Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results

You are allergic to letrozole.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Stimulation

Participants undergo controlled ovarian hyperstimulation with either letrozole or placebo

2 weeks

Baseline ultrasound, day of trigger shot

Egg Retrieval and Immediate Post-Retrieval

Egg retrieval occurs, and medication is continued for 2 weeks post retrieval

2 weeks

Egg retrieval, follow-up visits for medication continuation

Follow-up

Participants are monitored for endometriosis-related symptoms and other outcomes

12 weeks

Surveys at 3, 6, and 12 weeks post retrieval

Treatment Details

Interventions

• Letrozole
• Placebo oral tablet

Trial Overview 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.

Participant Groups

Group I: Endometriosis Letrozole Experimental Treatment 1 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 Control Active Control 1 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 Placebo Placebo Group 1 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.

Letrozole is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Femara for:

• Breast cancer in postmenopausal women
• Increasing the chance of ovulation in women with polycystic ovary syndrome

Approved in European Union as Letrozole for:

• Early breast cancer in postmenopausal women
• Advanced breast cancer in postmenopausal women

Approved in Canada as Letrozole for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+