NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel
NCT ID: NCT00229593
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
140 participants
INTERVENTIONAL
2005-09-30
2007-01-31
Brief Summary
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Detailed Description
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We propose to evaluate whether NES gel alone or in combination with T gel applied transdermally will result in more effective suppression of gonadotropins than NES or T gel applied alone in healthy men. Fifty healthy male subjects, age 18-50 will be enrolled at each center (2 sites).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
100 mg Testosterone gel daily for 3 weeks
Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
2
2 mg Nestorone gel daily for 3 weeks
Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
3
4 mg Nestorone gel daily for 3 weeks
Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
4
100 mg Testosterone gel + 2 mg Nestorone gel
Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
5
100 mg Testosterone gel + 4 mg Nestorone gel
Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
6
100 mg Testosterone Gel + 6 mg Nestorone Gel daily for 3 weeks
Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
7
100 mg Testosterone Gel + 8 mg Nestorone gel daily for 3 weeks
Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Interventions
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Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
50 Years
MALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Washington
OTHER
Responsible Party
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William Bremner
Study Principal Investigator
Principal Investigators
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William J Bremner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Christina Wang, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Harbor-UCLA Medical Center
Torrance, California, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.
Anderson RA, Kinniburgh D, Baird DT. Suppression of spermatogenesis by etonogestrel implants with depot testosterone: potential for long-acting male contraception. J Clin Endocrinol Metab. 2002 Aug;87(8):3640-9. doi: 10.1210/jcem.87.8.8773.
Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300.
Brache V, Massai R, Mishell DR, Moo-Young AJ, Alvarez F, Salvatierra AM, Cochon L, Croxatto H, Robbins A, Faundes A. Ovarian function during use of Nestorone(R) subdermal implants. Contraception. 2000 Mar;61(3):199-204. doi: 10.1016/s0010-7824(00)00092-5.
Cummings DE, Bremner WJ. Prospects for new hormonal male contraceptives. Endocrinol Metab Clin North Am. 1994 Dec;23(4):893-922.
Diaz S, Schiappacasse V, Pavez M, Zepeda A, Moo-Young AJ, Brandeis A, Lahteenmaki P, Croxatto HB. Clinical trial with Nestorone subdermal contraceptive implants. Contraception. 1995 Jan;51(1):33-8. doi: 10.1016/0010-7824(94)00006-i.
Gonzalo IT, Swerdloff RS, Nelson AL, Clevenger B, Garcia R, Berman N, Wang C. Levonorgestrel implants (Norplant II) for male contraception clinical trials: combination with transdermal and injectable testosterone. J Clin Endocrinol Metab. 2002 Aug;87(8):3562-72. doi: 10.1210/jcem.87.8.8710.
Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A. Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55. doi: 10.1016/0010-7824(92)90140-o.
Handelsman DJ, Conway AJ, Howe CJ, Turner L, Mackey MA. Establishing the minimum effective dose and additive effects of depot progestin in suppression of human spermatogenesis by a testosterone depot. J Clin Endocrinol Metab. 1996 Nov;81(11):4113-21. doi: 10.1210/jcem.81.11.8923869.
Kamischke A, Heuermann T, Kruger K, von Eckardstein S, Schellschmidt I, Rubig A, Nieschlag E. An effective hormonal male contraceptive using testosterone undecanoate with oral or injectable norethisterone preparations. J Clin Endocrinol Metab. 2002 Feb;87(2):530-9. doi: 10.1210/jcem.87.2.8218.
Kamischke A, Venherm S, Ploger D, von Eckardstein S, Nieschlag E. Intramuscular testosterone undecanoate and norethisterone enanthate in a clinical trial for male contraception. J Clin Endocrinol Metab. 2001 Jan;86(1):303-9. doi: 10.1210/jcem.86.1.7057.
Mahabadi V, Amory JK, Swerdloff RS, Bremner WJ, Page ST, Sitruk-Ware R, Christensen PD, Kumar N, Tsong YY, Blithe D, Wang C. Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men. J Clin Endocrinol Metab. 2009 Jul;94(7):2313-20. doi: 10.1210/jc.2008-2604. Epub 2009 Apr 14.
Other Identifiers
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HHSN27500002;
Identifier Type: -
Identifier Source: secondary_id
04-3792-D 02
Identifier Type: OTHER
Identifier Source: secondary_id
26852-D
Identifier Type: -
Identifier Source: org_study_id