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NCT05206448 · ClinicalTrials.gov registry record · Phase 4
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation
A Phase 4 study of Infertility and Polycystic Ovary Syndrome, sponsored by Rachel Mejia.
- Active
- Registry status
- Phase 4
- Development phase
- 190
- Enrollment target
- 4
- Study locations
NCT05206448: Active Phase 4 study of Infertility and Polycystic Ovary Syndrome, sponsored by Rachel Mejia.
NCT05206448 is a Phase 4 study of Infertility and Polycystic Ovary Syndrome that is active but no longer recruiting, run by Rachel Mejia. The registered enrollment target is 190 participants, below the 7,587-participant average among 74 other Infertility trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206448, a Phase 4 study of Infertility and Polycystic Ovary Syndrome, is active but no longer recruiting, sponsored by Rachel Mejia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 190 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study evaluates the addition of clomiphene citrate (CC) to letrozole for the treatment of infertility in women with polycystic ovary syndrome across a course of two treatment cycles with stair step dosing of letrozole similar to standard of care. Half of the participants will receive letrozole and CC in combination, while the other half will receive letrozole alone.
Primary Outcome
Number of Participants with Mid-luteal serum progesterone level \>=3 ng/ml Number of cycles with Mid-luteal serum progesterone level \>=3 ng/ml
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Clomiphene Citrate
Study Locations (4)
Iowa
- University of Iowa Hospitals & Clinics - Davenport Clinic - Davenport
- University of Iowa Hospitals & Clinics - Iowa City
- University of Iowa Hospitals & Clinics- West Des Moines Clinic - West Des Moines
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2025-12 |
| Phase | Phase 4 |
What the registry record for NCT05206448 still lists
NCT05206448 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 7,587-participant average among 74 other Infertility trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Infertility appearing as the primary indexed condition, and to 2 interventions - of which Letrozole is the first listed.
NCT05206448 reports a single indexed study location in Iowa, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05206448 about?
NCT05206448 is a clinical study titled "Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation". This study evaluates the addition of clomiphene citrate (CC) to letrozole for the treatment of infertility in women with polycystic ovary syndrome across a course of two treatment cycles with stair step dosing of letrozole similar to standard of care. Half of the participants will receive letrozole ...
What is the current status of trial NCT05206448?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 190 participants. The study started on 2020-10-26. Estimated completion is 2025-12.
What conditions does trial NCT05206448 study?
This clinical trial studies the following conditions: Infertility, Polycystic Ovary Syndrome, PCOS.
What interventions are being tested in trial NCT05206448?
The interventions under investigation include: Letrozole (DRUG), Clomiphene Citrate (DRUG).
Who is sponsoring clinical trial NCT05206448?
This trial is sponsored by Rachel Mejia, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05206448 being conducted?
This trial has 4 study locations across Iowa, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05206448's enrollment target sits among peer trials
190 42nd of 74 higher than 33 of 74 other Infertility trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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