NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel

Completed · Phase 1

Conditions studied: Contraception

In brief

The purpose of this study is to determine the usefulness of two transdermal gels to be used in the future development for a male contraceptive.

Key facts

Study ID

NCT00229593

Run by

University of Washington

People needed

140

Starts

2005-09-01

Expected to finish

2007-01-01

Last updated by the study team

2014-12-04

Who can join

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

You may qualify if…

• Healthy men
• Aged 18-50 years
• With normal clinical chemistry, serum levels of testosterone, PSA, gonadotropins within normal limits, and sperm concentration greater than 20 million/mL
• Subject or his partner willing to use a recognized effective method of contraception

You may not qualify if…

• Men not living in area of clinics
• Clinically significant abnormal findings at screening
• Elevated PSA greater than 4
• Partners who are pregnant
• Abnormal laboratory values, liver or kidney dysfunction
• Sperm counts below 20 million/mL.
• Use of androgens or body building substances within 6 months of enrollment,
• Blood pressure greater than 140/90, history of hypertension, including hypertension controlled with treatment
• History of primary testicular disease or disorder of the hypothalamic-pituitary axis
• Hypersensitivity of progestins
• History of venous thromboembolism
• Benign or malignant liver tumors
• Active liver disease, history of reproductive dysfunction including vasectomy or infertility
• History of active or chronic cardiac, renal, hepatic or prostatic disease
• Diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight)
• Known or suspected alcoholism or drug abuse
• Known dermatitis or severe skin disorder
• Men desiring fertility within 6 months or 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

• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Washington Medical Center — 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.