Letrozole for Endometrioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UCSF Center for Reproductive Health, San Francisco, CA
Endometrioma+1 More
Letrozole - Drug
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether ovarian hyperstimulation impacts endometriosis-related symptoms.

See full description

Eligible Conditions

  • Endometrioma
  • Ovarian Hyperstimulation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Endometrioma

Study Objectives

This trial is evaluating whether Letrozole will improve 1 primary outcome and 7 secondary outcomes in patients with Endometrioma. Measurement will happen over the course of 2 weeks.

2 weeks
Embryo Grade
Day 12
Average Delta in Endometriosis Pain Score Pre and Post Stimulation Compared to No Endometriosis
Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole
Day 14
Does Letrozole Impact Embryo and Egg Quantity in Endometriosis
Follicular Fluid
Day 7
Egg Maturity
Week 12
Trend in Endometriosis Pain Score Pre and Post Stimulation With Use Of Letrozole
Up to 2 years.
Pregnancy Outcomes

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Endometrioma

Side Effects for

Anastrozole
Fracture
10%
Acne
8%
Scoliosis
5%
Hair loss
3%
Sacroiliitis
3%
Neuro event
3%
Aggression
0%
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02137538) in the Anastrozole ARM group. Side effects include: Fracture with 10%, Acne with 8%, Scoliosis with 5%, Hair loss with 3%, Sacroiliitis with 3%.

Trial Design

3 Treatment Groups

No Endometriosis Control
1 of 3
Endometriosis Letrozole
1 of 3
Endometriosis Placebo
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Letrozole is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Endometriosis Letrozole
Drug
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.
Endometriosis Placebo
Drug
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.
No Endometriosis ControlParticipants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years. for reporting.

Closest Location

UCSF Center for Reproductive Health - San Francisco, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-42 years
Planning to undergo controlled ovarian hyperstimulation
Prior diagnosis of endometriosis by one of the following: (1) surgical diagnosis (2) endometrioma on pelvic ultrasound
Planning to freeze all retrieved oocytes/embryos prior to transfer

Patient Q&A Section

What are common treatments for endometrioma?

"The treatment of endometriosis remains controversial. A surgical conservative treatment should be considered as the first-line treatment in patients with a history of previous endometriosis resection who are not pregnant and have no prior abdominal pain. Surgery may be considered in patients with persistent or recurrent symptoms after resection or for symptom control and as an alternative to pharmacotherapy. Laparoscopic surgery may decrease the requirement for analgesics and shorten the hospital stay. In patients who fail to respond to surgery, hormonal therapy may be used to restore menstrual flow and improve quality of life. Treatment of endometriosis may require several different pharmacologic agents." - Anonymous Online Contributor

Unverified Answer

What are the signs of endometrioma?

"While symptoms are highly variable, the most common symptoms, and signs, that help to identify endometrioma consist of the following: abdominal pain and/or discomfort, vaginal bleeding, and/or infertility. [Bibliography omitted] endometrioma is an encapsulated benign tumor. The cells are normally dispersed within a stromal sac that is covered from both outside and inside by the endometrium. As the body ages, there is an increased rate of endometriosis, which also causes uterine fibroids. The fibroid cells proliferate, pushing out the endometrium. As this occurs, the endometrium begins to bleed. Fibroids do not invade the peritoneum." - Anonymous Online Contributor

Unverified Answer

What causes endometrioma?

"We concluded that endometriomas are most likely to occur in late-onset (older) women, particularly postmenopausal women, and are typically benign or borderline in a histological (mucosal) context. In these cases, uterine endometrium is exposed and at risk, but the cause remains to be determined." - Anonymous Online Contributor

Unverified Answer

How many people get endometrioma a year in the United States?

"There is a higher prevalence of endometriomas among black women, but black women make up only 28 to 33% of the population in many U.S. metropolitan areas without a minority population. In addition, the number of women with endometriomas is stable. This suggests that preventive measures to reduce the prevalence and the number of patients are probably not justified." - Anonymous Online Contributor

Unverified Answer

Can endometrioma be cured?

"We believe that endometrioma biopsy should be done when biopsy is suggested, or when the endometrioma is large or is thought to have been present for more than 3 cycles of gonadotropin stimulating hormone (Sperm or NorEstrada or NorLutea)(norethisterone enantimorph, Progynon, GnRH-antagonist, Lupron or Triptorelin)." - Anonymous Online Contributor

Unverified Answer

What is endometrioma?

"Endometrioma is a benign tumoural growth that is characterized by the presence of endometrial tissues that line the uterus. It is more common in women over 45. Because endometriomas have a higher chance of becoming symptomatic in women, especially in those who have menstrual irregularities and infertility, there is an [increased need for ultrasonography of the pelvis and lower abdomen.] If you are looking for an ideal treatment for the endometrioma, a surgical procedure [endometrial curettage (EC)] can be the best treatment as it completely removes the endometrial tissue without scars." - Anonymous Online Contributor

Unverified Answer

What is the latest research for endometrioma?

"The surgical staging of endometriosis and the definitive treatment of endometrioma is determined by the extent and nature of adenomegaly, the absence or presence of ascites and bowel, peritoneal fluid, or ovarian involvement with endometriosis. Further studies and an understanding of the impact of the type of surgery on residual adenoma and recurrence of disease are needed." - Anonymous Online Contributor

Unverified Answer

Does letrozole improve quality of life for those with endometrioma?

"Compared with placebo, treatment with letrozole for 6 months results in improved quality of life and reduced pain; however, these benefits are not sustained in the long term." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving letrozole?

"Letrozole does not appear to significantly reduce the number of endometrioma lesions in these placebo-controlled clinical trials. Other potential options for treatment of endometrioma include the use of progestogens, surgery, and hormonal therapy. The effectiveness of these options requires additional investigation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for endometrioma?

"Most women would respond well to hormonal/antibiotic therapy, and clinical trials will probably never provide a permanent cure with these drugs. The likelihood and duration to get pregnant with children are uncertain in this cohort, and this should be considered when evaluating a patient's potential for reproduction. Results from a recent paper does not compare two treatment options which are both effective in halting the disease." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets endometrioma?

"A large percentage of patients receive a diagnosis of endometrioma for menarche after the age of 15, and this number remains constant through all of the patient's life. On average age at menarche (the age at which a woman first begins menstruation) is around 12 years of age. Thus this disease appears to be more common than initially thought, and women should be informed about this, especially in the light of the increased longevity experienced by many." - Anonymous Online Contributor

Unverified Answer

Has letrozole proven to be more effective than a placebo?

"In a recent study, findings showed that letrozole was more effective in suppressing tumours both at a short and long term when compared with placebo." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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