Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

Clinical Trial Details

The purpose of this study is to assess serum testosterone levels after administration of clomiphene citrate (CC) in men with low serum testosterone.

Clomiphene citrate is approved by the U.S. Food and Drug Administration (FDA) to treat some types of infertility in women and is sometimes prescribed off-label for treatment of low testosterone in men. Clomiphene citrate is not FDA approved for this purpose.

Participants will be randomized into one of two study groups to receive either 25 mg of clomiphene citrate daily or 50 mg of clomiphene citrate every other day. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. Participants will be informed about the dose of the study medication they are receiving.

Total study participation will last for up to 16 weeks, including screening and follow-up, and will include coming into the office for blood draws at various stages throughout the study.

Key Eligibility:

Open to men between 21-45 years of age with testosterone deficiency.
Participants must not have used hormone-modifying medications, had any prior chemotherapy or radiation therapy to the groin/pelvis, or have a history of testicular or prostate cancer.

Detailed eligibility will be reviewed when you contact the study team.

Return to List

Study contact by location

Upper East Side - Manhattan

Contact(s)

Grace Tan
212-746-3208
grt2008@med.cornell.edu

Primary Investigator(s)

Jessica Marinaro, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2010022773

ClinicalTrials.gov:

NCT05096169

Status

Open to Enrollment

Age Group

Adult

Disease

Testosterone Deficiency

Urology