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Aromatase Inhibitor

Letrozole + GnRH Antagonist for Healthy Subjects

Phase 1 & 2
Waitlist Available
Led By Janet E Hall, M.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of androgen excess
Normal Liver Function Test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up efp: average of menstrual cycle day 6 in the efp; lfp: average of 2 days after follicle size of 16 mm
Awards & highlights

Study Summary

This trial is looking at the effects of two drugs, letrozole and NAL-GLU GnRH antagonist, on women's hormone levels. The purpose is to study how the drugs affect the menstrual cycle and fertility.

Who is the study for?
This trial is for healthy women aged 18-35 with regular menstrual cycles and no hormonal medication use in the last 3 months. Participants must not be trying to conceive, have a history of hormone-dependent cancer, substance abuse, or liver/kidney disease. They should use reliable contraception during the study.Check my eligibility
What is being tested?
The study tests Letrozole's effects on estrogen blocking and FSH control in normal women and those with GnRH deficiency. It also examines how NAL-GLU GnRH antagonist impacts hormone stimulation by temporarily blocking GnRH action.See study design
What are the potential side effects?
Potential side effects may include changes in menstrual cycle, mood swings, hot flashes, bone density reduction due to lowered estrogen levels from Letrozole, and possible injection site reactions from the NAL-GLU GnRH antagonist.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have high levels of male hormones.
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My liver function tests are normal.
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I am between 18 and 35 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~efp: average of menstrual cycle day 6 in the efp; lfp: average of 2 days after follicle size of 16 mm
This trial's timeline: 3 weeks for screening, Varies for treatment, and efp: average of menstrual cycle day 6 in the efp; lfp: average of 2 days after follicle size of 16 mm for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FSH Level

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

Trial Design

2Treatment groups
Experimental Treatment
Group I: Aromatase inhibitor LFPExperimental Treatment2 Interventions
Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2. Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Group II: Aromatase inhibitor EFPExperimental Treatment2 Interventions
Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,340 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,573 Total Patients Enrolled
Janet E Hall, M.D.Principal InvestigatorMassachusetts General Hospital
10 Previous Clinical Trials
26,716 Total Patients Enrolled

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00351416 — Phase 1 & 2
Healthy Subjects Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT00351416 — Phase 1 & 2
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00351416 — Phase 1 & 2
Healthy Subjects Research Study Groups: Aromatase inhibitor EFP, Aromatase inhibitor LFP

Frequently Asked Questions

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

What does the scientific community know about Letrozole from other research?

"As of right now, 211 clinical trials are underway that involve Letrozole. Of those, 55 are in the critical Phase 3 stage. Most of the research is being conducted in San Francisco, but there are 13744 active trial sites across America."

Answered by AI

How many people are signing up to participate in this research?

"Unfortunately, this study is no longer enrolling patients. Although, if you are seeking other clinical trials, 895 studies are admitting healthy subjects and 211 trials are recruiting for Letrozole specifically."

Answered by AI

What is the common purpose of Letrozole?

"While letrozole is most often prescribed to treat breast cancer, it can also be used as part of anovulatory cycle therapy, tamoxifen treatment, and ovulation induction therapy."

Answered by AI

Are patients currently being recruited for this research?

"The clinical trial in question was last updated over 3 years ago, meaning it is not currently recruiting patients. However, there are 1106 other trials that are still open to participants."

Answered by AI

Does this research allow for volunteers that are senior citizens?

"The age range that is eligible for this trial starts at 18 and ends at 40 years old."

Answered by AI

To whom does this trial grant access?

"The ideal applicant for this clinical trial would be a healthy woman aged 18-40 who has not been taking any medications, including hormonal drugs, for at least 3 months. Additionally, she should have regular menstrual cycles every 25-35 days with ovulation confirmed by luteal phase progesterone levels >3 ng/ml. There should also be no evidence of androgen excess, normal TSH, prolactin and hemoglobin levels, and the use of double-barrier contraception is necessary. Finally, the woman must have a negative pregnancy test (serum) at the beginning of each cycle of study and normal liver function test"

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Reproductive Endocrine Unit, Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Letrozole Treatment in Normal and GnRH Deficient Women
Janet E. Hall, MD 2004. "Letrozole Treatment in Normal and GnRH Deficient Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00351416.
~1 spots leftby Apr 2025
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