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

NCT05206448 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-04-15

Study results available
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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.

Conditions

Interventions

DRUG

Letrozole

Letrozole tablet

DRUG

Clomiphene Citrate

Clomiphene Citrate tablet

Sponsors & Collaborators

  • Society for Reproductive Investigation

    collaborator UNKNOWN

  • American Society for Reproductive Medicine

    collaborator UNKNOWN

  • University of Wisconsin, Madison

    collaborator OTHER

  • Rachel Mejia

    lead OTHER

Principal Investigators

  • Rachel Mejia, DO · University of Iowa Hospitals & Clinics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2024-04-12
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05206448 on ClinicalTrials.gov