Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

Completed · Phase 1

Conditions studied: Contraception

In brief

To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Key facts

Study ID: NCT00891228
Run by: Premier Research
People needed: 99
Starts: 2009-05-01
Expected to finish: 2011-11-01
Last updated by the study team: 2018-05-24

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Men who meet all the following criteria are eligible for enrollment in the trial:
Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
18 to 50 years of age
BMI ≤ 33 calculated as weight in Kg/ (height in cm) 2
No history of hormonal therapy use in the last six months prior to the first screening visit
Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, use double-barrier contraception) during the course of the study treatment and recovery phase
In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form
Does not meet any of the exclusion criteria.

You may not qualify if…

Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit
Men not living in the catchment's area of the clinic or within a reasonable distance from the site
Clinically significant abnormal findings at screening
Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values
Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
Sperm concentration below 15 million/mL in more than one of three screening samples
Use of androgens or body building substances within 6 months before first screening visit
Diastolic (D) blood pressure (BP) ≥ 85 and Systolic (S) BP ≥ 135 mm Hg; (BP will be taken 3 times at 5 minute intervals and the mean of all measurements be considered)
History of hypertension, including hypertension controlled with treatment
Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis
Known hypersensitivity to progestins
Family or personal history of venous thromboembolism
Benign or malignant liver tumors; active liver disease
History of breast carcinoma
Known history of reproductive dysfunction including vasectomy or infertility
Known history of cardiac, renal, hepatic or prostatic disease
A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above)
History of sleep apnea
Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance
Known dermatitis or severe skin disorder
Partner is known to be pregnant
Men desiring fertility within the first 24 weeks of study participation.
Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.

Where it is running

Los Angeles Biomedical Research Institute at Harbor-UCLA — Torrance, California, United States
University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.