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Selective Estrogen Receptor Modulator (SERM)
Letrozole + Clomiphene Citrate for Anovulation (CLC II Trial)
Phase 4
Waitlist Available
Led By Rachel Mejia, DO
Research Sponsored by Rachel Mejia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of polycystic ovary syndrome based on Revised Rotterdam criteria.
Partner with a normal sperm concentration and motility or total motile sperm count, or has fathered a pregnancy in the past
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
CLC II Trial Summary
This trial is testing whether adding clomiphene citrate to letrozole helps treat infertility in women with polycystic ovary syndrome.
Who is the study for?
This trial is for women with polycystic ovary syndrome (PCOS) who are struggling to get pregnant. They should be able to have regular intercourse and their partners must have normal sperm or a history of causing pregnancy. Women under 35 must have tried for a year, those over 35 for six months, without success.Check my eligibility
What is being tested?
The study is testing if adding clomiphene citrate (CC) to letrozole helps treat infertility in women with PCOS better than using letrozole alone. Participants will receive one of these two treatments randomly across two cycles.See study design
What are the potential side effects?
Letrozole and clomiphene can cause hot flashes, stomach upset, headaches, breast tenderness, mood swings, blurred vision and rarely increase the chance of having twins or more.
CLC II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with polycystic ovary syndrome.
Select...
My partner has normal sperm or has fathered a child before.
CLC II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ovulation
Secondary outcome measures
Clinical pregnancy
Conception
Endometrial thickness
+5 moreSide effects data
From 2018 Phase 4 trial • 79 Patients • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole
CLC II Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Letrozole + Clomiphene CitrateExperimental Treatment2 Interventions
Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomiphene Citrate 50 mg orally for 5 days on cycle days 3-7. Participants who ovulate and do not become pregnant will repeat the same treatment protocol for their next study cycle. Participants who do not ovulate will repeat the protocol with Letrozole dose increase of 2.5mg daily in the next treatment cycle to a maximum dose of 7.5 mg in the 3rd cycle, while maintaining the same dose of Clomiphene Citrate.
Group II: LetrozoleActive Control1 Intervention
Letrozole 2.5 mg orally for 5 days on cycle days 3-7 in first study treatment cycle. Participants who ovulate and do not become pregnant will repeat the same treatment protocol for their next study cycle. Participants who do not ovulate will repeat the protocol with Letrozole dose increase of 2.5 mg daily in the next treatment cycle, to a maximum dose of 7.5 mg in the 3rd cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved
Clomifene
FDA approved
Find a Location
Who is running the clinical trial?
Rachel MejiaLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Infertility
70 Patients Enrolled for Infertility
American Society for Reproductive MedicineUNKNOWN
University of Wisconsin, MadisonOTHER
1,182 Previous Clinical Trials
3,167,198 Total Patients Enrolled
1 Trials studying Infertility
224 Patients Enrolled for Infertility
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high prolactin levels that haven't been treated.I am willing and able to follow all study rules and attend all appointments.I have been diagnosed with polycystic ovary syndrome.I am currently using hormonal birth control methods.I haven't taken medication that affects fertility or metabolism in the last month.I have a known cause of infertility such as endometriosis, tubal issues, or uterine abnormalities.I can have regular intercourse during the study's ovulation phase.I have a thyroid condition that hasn't been treated.My partner and I have been unable to conceive despite trying for a specific period.I have been unable to get pregnant after trying for the required time based on my age.I cannot take clomiphene citrate or letrozole due to health reasons.I can have regular sexual intercourse during the study's ovulation phase.If you are a man, you need to have a certain amount of healthy sperm or have fathered a pregnancy before.My partner has normal sperm or has fathered a child before.If you have uncontrolled diabetes or high blood pressure, it's better to wait until they are under control before getting pregnant.You have been diagnosed with polycystic ovary syndrome based on specific medical criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Letrozole + Clomiphene Citrate
- Group 2: Letrozole
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation accepting participants who are over sixty years of age?
"The age criteria for this research trial necessitates that all participants must be between 18 and 40 years of age."
Answered by AI
What qualifications are necessary to qualify for this medical experiment?
"This medical trial is looking to recruit 184 individuals grappling with infertility, whose age falls between 18 and 40. The criteria for participation are as follows: a period of 12 months without successful pregnancy following regular unprotected intercourse (for those under 35) or 6 months without contraception use (if over 35); anovulation/oligomenorrhea; capacity for consistent sexual activity during the ovulatory induction phase; partner's sperm concentration at 15 million/mL with motility exceeding 40% per World Health Organization cutoffs, or total motile count higher than 10 mil.; and finally, willingness to comply with all study procedures throughout its duration."
Answered by AI
How many individuals have enrolled in this research project so far?
"Affirmative. Per the clinicaltrials.gov website, this research study is actively recruiting participants which began on October 26th 2020 and was recently updated on January 24th 2022. A total of 184 volunteers are sought from two different medical facilities."
Answered by AI
Are there any open slots for enrollment in this clinical trial?
"Affirmative. Clinicaltrials.gov data displays that this clinical trial, which commenced on October 26th 2020, is actively looking for new participants. A total of 184 individuals must be recruited from 2 distinct locations to complete the study."
Answered by AI
What side effects have been reported in patients taking Letrozole?
"Our team at Power assessed the safety of Letrozole to be a 3 since this is an approved Phase 4 trial, signifying that there is ample evidence attesting its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Texas
Kentucky
Other
How old are they?
18 - 65
What site did they apply to?
UIHC - Davenport Clinic
University of Wisconsin
University of Iowa Hospitals & Clinics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have been trying but not working.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
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