CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 190 enrolled
Drug / intervention
Letrozole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05206448
NCT05206448Phase 4Active
CompareCT.gov

Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation

Rachel Mejia·interventional·Posted Jan 25, 2022·Updated Apr 15, 2025

In Brief

A Phase 4 clinical trial evaluating Letrozole and Clomiphene Citrate for Polycystic Ovary Syndrome and 2 related conditions. Active but no longer recruiting, targeting 190 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome, PCOS, Infertility
CountriesUnited States
CollaboratorsSociety for Reproductive Investigation, American Society for Reproductive Medicine, University of Wisconsin, Madison

Timeline

Phase 4ActiveOverdue
202120222023202420252026
First PostedJan 25, 2022
Enrollment StartOct 26, 2020
Primary CompletionApr 12, 2024
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 4.4 years ago

Interventions

Letrozoledrug

Letrozole tablet

Clomiphene Citratedrug

Clomiphene Citrate tablet