Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Repros Therapeutics Inc.
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.
Age
18–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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