Letrozole for Endometriosis Pain Management
(APPOSE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMarcelle I Cedars

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

Prior Safety Data

Approved in 3 Jurisdictions

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.

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.

+1 more

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.

Participant Groups

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.

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.

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