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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT00229593
First received: September 27, 2005
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: Nestorone gel
Drug: Testosterone Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized, Open Label Clinical Trial to Evaluate if Nestorone Gel Has Gonadotropin Suppressive Activity and if Nestorone in Combination With Testosterone Will Have an Additive Effect on Gonadotropin Suppression When Applied Transdermally in Healthy Men

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • - To determine the gonadotropin suppressive activity of Nestorone (NES) Gel at two doses and T gel at one dose alone or in combination over a 3-week period. Serum levels of gonadotropins will be assessed in all subjects. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effects on serum levels of total and free testosterone and SHBG and measure serum levels of NES gel. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Safety measured laboratory evaluations, vitals, pre- and post treatment physical exam results and PSA levels [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: September 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
100 mg Testosterone gel daily for 3 weeks
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Name: Testim
Active Comparator: 2
2 mg Nestorone gel daily for 3 weeks
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 3
4 mg Nestorone gel daily for 3 weeks
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Active Comparator: 4
100 mg Testosterone gel + 2 mg Nestorone gel
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Name: Testim
Active Comparator: 5
100 mg Testosterone gel + 4 mg Nestorone gel
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Name: Testim
Active Comparator: 6
100 mg Testosterone Gel + 6 mg Nestorone Gel daily for 3 weeks
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Name: Testim
Active Comparator: 7
100 mg Testosterone Gel + 8 mg Nestorone gel daily for 3 weeks
Drug: Nestorone gel
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
Drug: Testosterone Gel
100 mg Testosterone gel daily for 3 weeks
Other Name: Testim

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 other adverse events. The treatment with androgen alone has geen shown to be highly effective in Asian men but less effective in non-Asian men in clinical trials. To increase the efficacy of androgen alone treatment on spermatogenesis, combined regimens of a progestin and an androgen have shown promising results. The steady-state delivery of a progestin and an androgen by transdermal gel application would be a user-friendly delivery method as compared to injectable or implant approaches. Nestorone (NES) is a synthetic progestin that does not have any androgenic and estrogenic activity and is not expected to have some of the undesirable side effects of other drugs.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00229593

Locations
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: William J Bremner, MD, PhD University of Washington
Principal Investigator: Christina Wang, MD University of California, Los Angeles
  More Information

Additional Information:
Publications:

Responsible Party: John Amory, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00229593     History of Changes
Other Study ID Numbers: 26852-D, HHSN27500002;, 04-3792-D 02
Study First Received: September 27, 2005
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
Male contraception
Androgen
Progestin
Spermatogenesis
Gonadotropin suppression
Testosterone
Nestorone

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
ST 1435
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 29, 2014