Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT01386606
Eligibility Criteria:
Inclusion Criteria:
* Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
* All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent
* Agreement to use a condom, and with a fertile female partner, another form of contraception.
* Agreement to provide a semen sample in the clinic
Exclusion Criteria:
* Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
* Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
* Use of Clomid in the past year or during the study
* Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
* A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
* Clinically significant abnormal findings on screening examination
* Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
* Known hypersensitivity to Clomid
* Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
* Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
* History of breast cancer
* History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \>3.6
* History of known hyperprolactinemia with or without a tumor
* Chronic use of medications use such as glucocorticoids
* Chronic use of narcotics
* Subjects known to be positive for HIV
* Subjects with end stage renal disease
* Subjects with cystic fibrosis (mutation of the CFTR gene)
* Subjects unable to provide a semen sample in the clinic
* Subject has a BMI \>42 kg/m2
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01386606
Study Brief:
Protocol Section:
NCT01386606