Status:
COMPLETED
NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Contraception
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
The success of hormonal male contraception depends on the near complete suppression of spermatogenesis without producing any untoward effects on libido or other androgen-dependent functions or any oth...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00229593
Start Date
September 1 2005
End Date
January 1 2007
Last Update
December 4 2014
Active Locations (2)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
2
University of Washington Medical Center
Seattle, Washington, United States, 98195